Thursday, March 17, 2016

Mar 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials

Mar 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials

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

Hepatitis Clinical Trials Listed By State
A listing of Hepatitis medical research trials actively recruiting patient volunteers. Click on the closest city to find more detailed information on a research study in your area.

Related
Feb 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials

Informational Links
For additional information on treatment options for genotypes 1-6, FDA approved or investigational hepatitis C regimens including Gileads Sofosbuvir/Velpatasvir or Abbvies ABT-493/ABT-530 please follow the links provided.

News and Research
HCV Genotypes and Treatment 
A collection of updated research and news articles with a focus on treating HCV according to genotype. Information is extracted from peer-reviewed journals, liver meetings/conferences, research manuscripts and interactive learning activities

PDF Download
Summarize recommended treatments for chronic hepatitis C genotypes 1-6

Sovaldi with velpatasvir
Gileads once-daily, fixed-dose combination of Sovaldi with velpatasvir is an investigational pangenotypic NS5Ainhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection

HCV Advocate
Drug Pipeline – Quick Reference Guides

NIH PubMed Search: hepatitis C

FDA Approved
Drug Summaries, Clinical Studies, and Slide Decks
All materials are available for download in their original formats as PDF or PowerPoint.
Daclatasvir (Daklinza)
Elbasvir-Grazoprevir (Zepatier)
Ledipasvir-Sofosbuvir (Harvoni)
Ombitasvir-Paritaprevir-Ritonavir (Technivie)
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak)
 
Upcoming and Recruiting Hepatitis C Clinical Trials

https://www.clinicaltrials.gov/ct2/home

ClinicalTrials.gov: updated in the last 30 days 

United States Canada
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

United States
Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease
‎Monday, ‎February ‎22, ‎2016, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention: Drug: LDV/SOF FDC
Sponsors: Peter J. Ruane, M.D., Inc.; Gilead Sciences
Not yet recruiting - verified February 2016

United States
Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection
‎Wednesday, ‎March ‎9, ‎2016, ‏‎12:00:00 PM
Conditions: HIV; Hepatitis C, Chronic
Intervention: Behavioral: Nurse Case Management
Sponsor: Johns Hopkins University
Not yet recruiting - verified March 2016

United States Canada Puerto Rico
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 ‎5, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified March 2016

United States Canada Australia France Germany New Zealand United Kingdom Puerto Rico
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
Recruiting - verified March 2016

United States Canada Australia France Germany New Zealand United Kingdom Russian Federation Sweden Switzerland
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
‎Tuesday, ‎December ‎22, ‎2015, ‏‎12:00:00 PM
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 March 2016

United States Canada France Germany New Zealand Puerto Rico United Kingdom
Safety and Efficacy of SOF/VEL/GS-9857 FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
‎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 March 2016

United States 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 March 2016

United States 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 February 2016

United States Australia 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 February 2016

Brazil 
An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection
‎Tuesday, ‎November ‎3, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention:
Sponsor: Janssen-Cilag Ltd.
Not yet recruiting - verified March 2016

Iran
Sofosbuvir, Ledipasvir, Ribavirin for HCV Cirrhotics, Genotype 1
‎Monday, ‎March ‎7, ‎2016, ‏‎12:00:00 PM
Conditions: Hepatitis C; Cirrhosis
Interventions: Drug: Sofosbuvir; Drug: Ledipasvir; Drug: Ribavirin
Sponsors: Tehran University of Medical Sciences; Bakhtar Bioshimi Co
Not yet recruiting - verified March 2016

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 March 2016

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
Recruiting - verified February 2016

Japan
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
‎Wednesday, ‎March ‎9, ‎2016, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C Virus; Hepatitis C Virus
Interventions: Drug: ABT-493/ABT-530; Drug: Ombitasvir/paritaprevir/ritonavir
Sponsor: AbbVie
Recruiting - verified March 2016

A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
‎Tuesday, ‎February ‎23, ‎2016, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; HCV; Hepatitis C Virus
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Not yet recruiting - verified February 2016

Iceland
Treatment as Prevention for Hepatitis C in Iceland
‎Wednesday, ‎December ‎30, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Intervention:
Sponsors: Landspitali University Hospital; SAA -National Center of Addiction Medicine
Recruiting - verified January 2016

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 March 2016



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