Wednesday, February 10, 2016

Feb 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials

Feb 2016 Update

The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.

Follow the links provided below for current research on both Gileads Sofosbuvir/Velpatasvir and Abbvies ABT-493/ABT-530 investigational hepatitis C regimens;

Gileads Sofosbuvir/Velpatasvir
Gileads Sofosbuvir/Velpatasvir to treat HCV Genotype 1-6 was recently granted FDA Grants Priority Review, read more here, on the blog here. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.   

Feb 11
Hepatitis C treatment studies from NEJM: Closer to One Size for All
The December 31, 2015 issue of the New England Journal of Medicine (NEJM) published three back-to-back-to-back articles on the results of clinical trials of sofosbuvir and velpatasvir in different hepatitis C populations. These three articles, published in the most prestigious medical journal, will likely form the basis of new HCV recommendations in the near future.

Abbvies  ABT-493/ABT-530
Read the press release for Abbvies six global Phase 3 studies for evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus regimen, ABT-493,and ABT-530, in patients with HCV genotypes 1-6 (GT1-6), here. To read additional updates posted on the  blog click here

FDA APPROVED ZEPATIER
Mercks ZEPATIER (Elbasvir (MK-8742) and Grazoprevir (MK-5172) was FDA approved on Jan 28 of this year, here is the Press Release, blog updates here.

For a quick reference guide of drugs under development please visit: HCV Advocate Hepatitis C Treatments in Current Clinical Development – Detailed Reference Guide.

FDA approved Hepatitis C Treatments, click here

Upcoming and Recruiting Hepatitis C Clinical Trials


The following trials are headed up under Sponsor and in no particular order

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Sponsor: Gilead Sciences
‎Friday, ‎January ‎29, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Intervention: Drug: SOF/VEL
Sponsor: Gilead Sciences
Not yet recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02671500
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Sponsor: Gilead Sciences
Locations: United States, California, San Francisco, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana , Louisiana, Maryland, , Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin
Australia, New South Wales, Canada, France, Germany, New Zealand, Puerto Rico,United Kingdom
Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
‎Monday, ‎November ‎16, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: SOF/VEL/GS-9857; Drug: SOF/VEL
Sponsor: Gilead Sciences
Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02607800
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Sponsor: Gilead Sciences
Locations: United States, California, Colorado, Washington, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee Texas, Utah, Virginia, Washington, Wisconsin
Australia, , Canada, France,Germany, New Zealand, Puerto Rico,United Kingdom
Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
‎Monday, ‎November ‎16, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: SOF/VEL/GS-9857; Drug: Placebo
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02607735
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Sponsor: Gilead Sciences
Locations: United States, California, Colorado, District of Columbia, Florida. Georgia. Illinois, Indiana, Louisiana, Maryland. Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington
Australia, Canada, France, Germany, New Zealand, Puerto Rico, United Kingdom,
‎Monday, ‎December ‎21, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL/GS-9857; Drug: SOF/VEL
Sponsor: Gilead Sciences
Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02639247
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Sponsor: Gilead Sciences
Locations: United States, California, Colorado, District of Columbia,Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts,Michigan, Missouri New Jersey, New York, North Carolina, Pennsylvania,Rhode Island, Tennessee, Texas, Utah, Virginia, Washington
Australia, Canada, France, Germany New Zealand, Puerto Rico,United Kingdom
Safety and Efficacy of SOF/VEL/GS-9857 FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
‎Monday, ‎December ‎21, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL/GS-9857; Drug: SOF/VEL
Sponsor: Gilead Sciences
Some Locations Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02639338
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Sponsor: Gilead Sciences
Locations: United States, California, District of Columbia, Florida, Georgia, Indiana, Maryland, Massachusetts, Missouri, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia
Australia, Belgium, Germany, Italy, New Zealand, Russian Federation, United Kingdom
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
‎Tuesday, ‎June ‎24, ‎2014, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF (oral tablets); Drug: RBV; Drug: SOF (oral granules)
Sponsor: Gilead Sciences
Recruiting - verified February 2016
ClinicalTrials.gov Identifier:NCT02175758
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Sponsor: Gilead Sciences
Locations: United States, Alabama, Arizona, California, Colorado, District of Columbia, Florida
Georgia, Indiana, Kentucky, Maryland, Massachusetts, Missouri, Nebraska, New York,North Carolina, Ohio, Pennsylvania, Tennessee Texas, Washington, West Virginia
Australia, New Zealand, United Kingdom
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
‎Tuesday, ‎September ‎23, ‎2014, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: Placebo to match LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:
NCT02249182 
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Sponsor: AbbVie
Locations: United States, California, Florida, New Mexico, New York, North Carolina, Rhode Island
Washington 
Belgium, Canada. Germany, South Africa
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
‎Monday, ‎December ‎28, ‎2015, ‏‎12:00:00 PM
Conditions: Hepatitis C Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Some Locations Recruiting - verified January 2016 
ClinicalTrials.gov Identifier:NCT02642432
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Sponsor: AbbVie
Locations: United States, California, Florida, Georgia, Louisiana, Maryland, New Jersey,Texas, Washington
Belgium, France, Italy, Korea, Lithuania, Portugal, Taiwan
Condition: Chronic Hepatitis C Virus (HCV) Infection
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02640482
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Sponsor: AbbVie
Locations: United States, Alabama, California, Colorado, Florida, Louisiana, Louisiana
Minnesota, ,New York, North Carolina, Oregon, Rhode Island, Texas
Australia, Canada,  France, New Zealand, Russian,  Sweden, Switzerland, United Kingdom
Conditions: Chronic Hepatitis C; Hepatitis C Virus; Genotype 3 Hepatitis C Virus
Interventions: Drug: ABT-493/ABT-530; Drug: sofosbuvir; Drug: daclatasvir; Drug: daclatasvir
Sponsor: AbbVie
Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02640157
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Sponsor: AbbVie
Locations: Belgium, Canada, France, Italy, Portugal, South Africa, Spain, United Kingdom
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)  (ENDURANCE-4)
‎Wednesday, ‎December ‎16, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Recruiting - verified February 2016 
ClinicalTrials.gov Identifier: NCT02636595
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Sponsor: AbbVie
Locations: United States, California, Florida, Illinois, Indiana, Maryland, Michigan, New Jersey
North Carolina, Tennessee, Wisconsin
Australia, Austria, Belgium, Canada, Chile, France, Germany, Hungary, Israel, Italy
Korea, Lithuania, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Sweden, Switzerland,Taiwan, United Kingdom
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
‎Wednesday, ‎November ‎11, ‎2015, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C Virus; HCV
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02604017
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Sponsor: AbbVie
Locations: Russian
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
‎Thursday, ‎January ‎28, ‎2016, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Genotype 1
Intervention: Drug: ABBVIE REGIMEN ± RBV
Sponsor: AbbVie
Not yet recruiting - verified January 2016
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Sponsor: Bristol-Myers Squibb
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
‎Thursday, ‎January ‎28, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: DCV; Drug: SOF; Drug: RBV
Sponsor: Bristol-Myers Squibb
Not yet recruiting - verified February 2016
Please refer to this study by its ClinicalTrials.gov identifier: NCT02673489
Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
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Sponsor: Merck
Locations: United States, Florida
A Study of the Pharmacokinetics of MK-3682 and MK-8408 in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
‎Monday, ‎January ‎25, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C, Chronic
Interventions: Drug: MK-3682; Drug: MK-8408
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02666352
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Sponsor: FixHepC
Locations: Australia, Tasmania
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
‎Thursday, ‎January ‎14, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Sofosbuvir+Ledipasvir; Drug: Sofosbuvir+Daclatasvir
Sponsor: FixHepC
Enrolling by invitation - verified January 2016
Sponsor: AbbVie
Locations: Poland
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C
‎Monday, ‎December ‎21, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsors: AbbVie; IST GmbH, Germany
Recruiting - verified January 2016 
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Sponsor: AbbVie
Locations: Germany
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)
‎Tuesday, ‎November ‎24, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified February 2016
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Sponsor: AbbVie
Locations: France
The Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
‎Tuesday, ‎November ‎24, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified February 2016
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Sponsor: Gilead Sciences
Locations: Taiwan
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
‎Monday, ‎November ‎23, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Intervention: Drug: LDV/SOF
Sponsor: Gilead Sciences
Recruiting - verified February 2016
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Sponsor: Merck
Locations: United States, California, Colorado, Florida, Georgia, Indiana, Louisiana, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, North Carolina, Pennsylvania , Texas,Washington
France, Germany, Spain, Sweden
Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
‎Friday, ‎November ‎20, ‎2015, ‏‎12:00:00 PM
Conditions: Hepatitis; Hepatitis C; Digestive System Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Liver Diseases; RNA Virus Infections; Virus Diseases
Interventions: Drug: MK- 3682B; Drug: Ribavirin
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02613403
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Sponsor: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Locations: United States, California, Illinois, Missouri, New York, Texas
12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
‎Thursday, ‎November ‎12, ‎2015, ‏‎12:00:00 PM
Conditions: HIV-1 Infection; Hepatitis C
Interventions: Drug: Ledipasvir/sofosbuvir; Drug: Ribavirin
Sponsors: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02605304
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Sponsor: Merck
Locations: United Kingdom
Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection
‎Monday, ‎November ‎09, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir; Drug: Elbasvir; Drug: Ribavirin; Drug: Sofosbuvir
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02601573
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Sponsor: Erasmus Medical Center
Locations: Belgium, Netherlands
Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
‎Thursday, ‎November ‎05, ‎2015, ‏‎12:00:00 PM
Conditions: Acute Hepatitis C; Human Immunodeficiency Virus; Hepatitis C
Intervention: Drug: Grazoprevir/Elbasvir 100mg/50mg
Sponsor: Erasmus Medical Center
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02600325
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Sponsor: Gilead Sciences
Locations: United States, California, Florida, Louisiana, Maryland, Minnesota, Missouri
New Jersey, North Carolina, Texas
Canada
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
‎Thursday, ‎November ‎05, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02600351
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Sponsor: Gilead Sciences
Locations: India
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
‎Thursday, ‎October ‎29, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention: Drug: SOF
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02592057
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Sponsor: University of Colorado, Denver
Locations: United States, Colorado
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
‎Monday, ‎October ‎26, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C and HIV Coinfection
Intervention: Other: Blood draws for tenofovir PK, renal function
Sponsor: University of Colorado, Denver
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02588287
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Sponsor: Ottawa Hospital Research Institute
Collaborators: Gilead Sciences, CIHR Canadian HIV Trials Network
HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection
‎Wednesday, ‎October ‎21, ‎2015, ‏‎12:00:00 PM
Conditions: Human Immunodeficiency Virus; Hepatitis C, Chronic
Interventions: Drug: E/C/F/TAF;; Drug: Ledipasvir-Sofosbuvir
Sponsors: Ottawa Hospital Research Institute; Gilead Sciences; CIHR Canadian HIV Trials Network
Not yet recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02660905 
Contact: Curtis Cooper, MD, FRCPC 613-737-8899 ext 78924 ccooper@ohri.ca 
_________________________________________________________

Sponsor: AbbVie
Locations: Austria
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
‎Tuesday, ‎October ‎20, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: Ireland
The Effectiveness of ABT-450/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
‎Tuesday, ‎October ‎20, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: Canada - Many Locations
Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada
‎Monday, ‎October ‎19, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsors: AbbVie; IST GmbH, Germany; Cato Research
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02581189
Contact: Nabil Ackad, MD 514-832-7439 nabil.ackad@abbvie.com
Contact: Catherine Pinsonnault, BS 514-832-7015 catherine.pinsonnault@abbvie.com 
_________________________________________________________

Sponsor: AbbVie
Locations: Japan
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
‎Monday, ‎October ‎19, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention:
Sponsor: AbbVie
Not yet recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: Belgium
Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, +/- Dasabuvir, +/- Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
‎Monday, ‎October ‎19, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C, Genotype 1 or 4
Intervention:
Sponsors: AbbVie; IST GmbH, Germany
Recruiting - verified February 2016
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Sponsor: Alios Biopharma Inc.
Locations: New Zealand
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, ACH-3102, and Simeprevir
‎Thursday, ‎October ‎01, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Interventions: Drug: AL-335; Drug: ACH-3102; Drug: Simeprevir
Sponsor: Alios Biopharma Inc.
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02569710
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Sponsor: Gilead Sciences
Locations: Japan
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
‎Monday, ‎September ‎28, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: SOF; Drug: REB
Sponsors: Gilead Sciences; Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
_________________________________________________________

Sponsor: Gilead Sciences
Locations Japan
Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
‎Friday, ‎August ‎28, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF; Drug: COPE
Sponsors: Gilead Sciences; Chugai Pharmaceutical
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: United States, Canada , Spain
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma
‎Monday, ‎July ‎20, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin
Sponsor: AbbVie
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02504099
_________________________________________________________

Sponsor:  AbbVie
Locations: United States, New York, France
Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
‎Thursday, ‎July ‎02, ‎2015, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir; Drug: ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02493855
_________________________________________________________

Sponsor:  AbbVie
Locations: Australia, New Zealand, Spain, United Kingdom
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
‎Monday, ‎June ‎29, ‎2015, ‏‎12:00:00 PM
Conditions: HCV; Genotype 1a; Genotype 4; Chronic Kidney Disease; Hepatitis C; pegIFN; IFN
Interventions: Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02487199
_________________________________________________________

Sponsor:  Gilead Sciences
Locations: Egypt
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
‎Saturday, ‎June ‎27, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02487030
_________________________________________________________

Sponsor:  AbbVie
Locations: United States, Massachusetts
Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
‎Wednesday, ‎June ‎17, ‎2015, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir; Drug: ribavirin
Sponsor: AbbVie
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02476617
_________________________________________________________

Sponsor: AbbVie
Locations: United States, California, Colorado, Florida, Indiana, Louisiana, Massachusetts
New York, North Carolina, Ohio, Pennsylvania, Texas, Washington
Canada
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
‎Wednesday, ‎June ‎17, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ombitasvir; Drug: paritaprevir; Drug: ritonavir; Drug: dasabuvir; Drug: ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02486406
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Sponsor: University Health Network, Toronto
Locations: Canada, Ontario
Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)
‎Friday, ‎June ‎05, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Viral Infection
Intervention: Drug: Sofosbuvir (SOF) and Ledipasvir (LDV)
Sponsor: University Health Network, Toronto
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02478229
_________________________________________________________

Sponsor: Janssen 
Locations: Belgium
A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
‎Wednesday, ‎April ‎15, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C, Chronic
Interventions: Drug: Simeprevir (SMV); Drug: Ledipasvir (LDV); Drug: Sofosbuvir (SOF)
Sponsor: Janssen Sciences Ireland UC
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02421211
_________________________________________________________

Sponsor: AbbVie
Locations: United States, Alabama, California, Colorado, Florida, North Carolina, Rhode Island Tennessee, Texas, Utah, Washington
A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Sofosbuvir and RBV in DAA Treatment-experienced Adults With Chronic Hepatitis C Virus Infection
‎Monday, ‎February ‎02, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: Ombitasvir/ABT-450/r; Drug: Dasabuvir; Drug: Sofosbuvir; Drug: Ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02356562
_________________________________________________________

Sponsor: Gilead Sciences
Locations: United States, California,  Illinois,  Louisiana, Michigan, New York, Texas
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
‎Monday, ‎January ‎26, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Intervention: Drug: LDV/SOF
Sponsor: Gilead Sciences
Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02350569 
_________________________________________________________

Sponsor: Merck 
Locations: United States, California, Colorado, Florida, Georgia, Illinois, Michigan, New Jersey,  New York, North Carolina, Oklahoma, Texas, Virginia, Wisconsin
Canada, Denmark, France, Germany, Israel, Italy, New Zealand
Efficacy and Safety of Grazoprevir (MK-5172) and MK-3682 With Elbasvir (MK-8742) or MK-8408 for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3 Infection (MK-3682-012)
‎Tuesday, ‎January ‎06, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir; Drug: MK-3682; Drug: Elbasvir; Drug: MK-8408; Drug: MK-3682B; Drug: RBV
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier:NCT02332720
_________________________________________________________

Sponsor: Merck 
Locations: United States, California,Coronado,United States, District of Columbia, Florida,Georgia,
Maryland,New Jersey,New Mexico,New York,North Carolina,Oklahoma,Pennsylvania,
Texas,Virginia
Austria, France, Italy, Lithuania, Poland, Puerto Rico, United Kingdom
Efficacy and Safety of Grazoprevir (MK-5172) and MK-3682 With Elbasvir (MK-8742) or MK-8408 for Chronic Hepatitis C Genotype (GT) 1 and GT2 Infection (MK-3682-011)
‎Tuesday, ‎January ‎06, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir; Drug: MK-3682; Drug: Elbasvir; Drug: MK-8408; Drug: MK-3682B; Drug: Ribavirin
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02332707
_________________________________________________________

Sponsor: AbbVie
Locations: Australia, Canada, New Zealand, United Kingdom
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With and Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
‎Thursday, ‎November ‎13, ‎2014, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Virus Infection
Interventions: Drug: Ombitasvir/ABT-450/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02292719 
_________________________________________________________

Sponsor: Merck
Locations: Vietnam
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
‎Thursday, ‎September ‎25, ‎2014, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir/Elbasvir; Drug: Placebo
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02251990 
_________________________________________________________

Sponsor: Bristol-Myers Squibb
Locations: Japan
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C ‎Wednesday, ‎September ‎24, ‎2014, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: Bristol-Myers Squibb
Recruiting - verified January 2016 

‎Thursday, ‎September ‎04, ‎2014, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C Virus
Interventions: Drug: ABT-493; Drug: ABT-530; Drug: Ribavirin (RBV); Drug: ABT-493/ABT-530
Sponsor: AbbVie
Recruiting - verified February 2016
_________________________________________________________

Sponsor: AbbVie
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
‎Thursday, ‎July ‎31, ‎2014, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
Interventions: Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir; Drug: Ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Locations: United States, Alabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Maryland, Massachusetts, Missouri, New JerseyNew Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Washington
Puerto Rico
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy
‎Thursday, ‎July ‎17, ‎2014, ‏‎12:00:00 PM
Condition: HIV Infections
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02194998
_________________________________________________________

Sponsors: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Locations: United States, California, Colorado,  Georgia, Illinois, Maryland, Massachusetts, Missouri, New York,  North Carolina, Pennsylvania, Rhode Island, Texas 
Puerto Rico
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection
‎Tuesday, ‎April ‎29, ‎2014, ‏‎12:00:00 PM
Conditions: HIV-1 Infection; Hepatitis
Interventions: Drug: Ribavirin; Drug: Sofosbuvir; Drug: Ledipasvir/Sofosbuvir
Sponsors: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02128217
_________________________________________________________

Sponsors: Centre hospitalier de l'Université de Montréal (CHUM); Canadian Institutes of Health Research (CIHR); Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Locations: Canada
Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound
‎Monday, ‎January ‎20, ‎2014, ‏‎12:00:00 PM
Conditions: Hepatitis C; Hepatitis B; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)
Intervention: Device: Transient elastography, acoustic radiation force impulse, magnetic resonance elastography
Sponsors: Centre hospitalier de l'Université de Montréal (CHUM); Canadian Institutes of Health Research (CIHR); Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Recruiting - verified January 2016 
ClinicalTrials.gov Identifier: NCT02044523
Contacts
Contact: An Tang, MD, MSc 514-890-8000 ext 36400 an.tang@umontreal.ca
Contact: Assia Belblidia 514-890-8000 ext 34369 assia.belblidia.chum@ssss.gouv.qc.ca

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