Thursday, June 16, 2016

June - Recruiting and upcoming hepatitis C clinical trials

Hello folks, as we wait for the FDA's final decision on the approval of Gilead's Sofosbuvir/Velpatasvir expected on June 28, here is a short list of recruiting and upcoming hepatitis C clinical trials for the month of June.

Peppered throughout this post you will find correlating news and interim results from ongoing hepatitis C clinical trials placed before some recruiting information.

However, this is not a complete list; to find out if a study is enrolling patients in your area, please click here, or here for hepatitis trials listed by state, as well as HCV Advocate Monthly Pipeline Update for additional information.

News
GS-9857, in combination with sofosbuvir and velpatasvir
June 14 2016
New Combination Therapy May Be Effective Against Chronic HCV Infection
NEW YORK (Reuters Health) - The new NS3/4A protease inhibitor GS-9857, in combination with sofosbuvir and velpatasvir (SOF/VEL), produces sustained viral response in most patients with hepatitis C virus (HCV) genotype 1 or 3 infections, according to a phase 2 trial from Gilead Sciences.

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02745535
Condition: Chronic Hepatitis C
Intervention: Drug: Sofosbuvir/Velpatasvir/GS-9857
Contacts
Contact: Eleanor Wilson, MD 410-706-1710 ewilson@ihv.umaryland.edu
Contact: Jennifer Hoffmann, MSN/MPH 410-706-0294 jhoffmann@som.umaryland.edu 
Locations
United States, Maryland
Institute of Human Virology Recruiting
Baltimore, Maryland, United States, 21201

News
Sofosbuvir/Velpatasvir
Jan 2016
Gilead's Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection received FDA priority review status in January 2016 -- Final FDA Decision Anticipated by June 28, 2016 --

May 2016
EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes
--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--

Research
Healio
VIDEO: Sofosbuvir/velpatasvir may offer improved patient reported outcomes
June 6
SAN DIEGO — In this exclusive video from DDW 2016, Zobair Younossi, MD, MPH, chairman of the department of medicine, Inova Fairfax Hospital, and vice president for research of Inova Health System, discusses new data showing the pan-genotypic regimen of a fixed-dose combination of Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir (Gilead Sciences) was associated with improved patient reported outcomes, or PROs.
Watch the video, here

Additional Information on this blogs website - Sovaldi /Velpatasvir​​

Not Recruiting Yet
This study is not yet open for participant recruitment
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781558
Contacts - Locations
Contact: Gilead Study Team 342-2097alerts@gilead.com
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL; Drug: RBV

Not Recruiting Yet
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781571
Contacts - Locations
Contact: Gilead Study Team 342-2104alerts@gilead.com
Condition: Hepatitis C Virus Infection Intervention: Drug: SOF/VEL Sponsor: Gilead Sciences
verified May 2016 (Source: ClinicalTrials.gov)
May 20, 2016

Recruiting
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Please refer to this study by its ClinicalTrials.gov identifier: NCT02671500
Condition: Hepatitis C Virus Infection
Intervention: Drug: SOF/VEL
Locations
Malaysia

University of Malaya Recruiting
Kuala Lumpur, Malaysia, 59100
Hospital Tengku Ampuan Afzan Recruiting
Pahang, Malaysia, 25100
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Singapore General Hospital Recruiting
Singapore, Singapore, 169608    

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02738333
Locations -  Japan
Contacts
Contact: Gilead Study Team GS-US-337-1903@gilead.com
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: SOF; Drug: RBV  

Research
Daclatasvir and Sofosbuvir
Hepatology May 2016
Patients with hepatitis C virus (HCV) genotype 3 infection, especially those with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection. The phase III ALLY-3+ study (N = 50) evaluated DCV-SOF with ribavirin (RBV) in treatment-naïve (n = 13) or treatment-experienced (n = 37) genotype 3-infected patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36).

Patients were randomized 1:1 to receive open-label DCV-SOF (60 + 400 mg daily) with weight-based RBV for 12 or 16 weeks. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12). SVR12 (intention-to-treat) was 90% overall (45 of 50): 88% (21 of 24) in the 12-week (91% observed) and 92% (24 of 26) in the 16-week group. All patients with advanced fibrosis achieved SVR12. SVR12 in patients with cirrhosis was 86% overall (31 of 36): 83% (15 of 18) in the 12-week (88% observed) and 89% (16 of 18) in the 16-week group; for treatment-experienced patients with cirrhosis, these values were 87% (26 of 30), 88% (14 of 16; 93% observed), and 86% (12 of 14), respectively. One patient (12-week group) did not enter post-treatment follow-up (death unrelated to treatment). There were 4 relapses (2 per group) and no virological breakthroughs. The most common adverse events (AEs) were insomnia, fatigue, and headache. There were no discontinuations for AEs and no treatment-related serious AEs.

Conclusion: The all-oral regimen of DCV-SOF-RBV was well tolerated and resulted in high and similar SVR12 after 12 or 16 weeks of treatment among genotype 3-infected patients with advanced liver disease, irrespective of past HCV treatment experience.
Read more....

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02673489
Condition: Hepatitis C
Interventions: Drug: DCV; Drug: SOF; Drug: RBV
Locations
United States, California
University Of Southern California
Los Angeles, California, United States, 90033
Contact: Saro Khemichian, Site 0011
U.Cal.-San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Norah Terrault, Site 0019
United States, Georgia
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, United States, 30060
Contact: Aasim Sheikh, Site 0018
United States, Illinois
Ruth M. Rothstein Core Center
Chicago, Illinois, United States, 60612
Contact: Gregory Huhn, Site 0010
United States, Maryland
Digestive Disease Associates, P.A.
Catonsville, Maryland, United States, 21228
Contact: Natarajan Ravendhran, Site 0014
United States, Pennsylvania
Eastern Pennsylvania Gastroenterology And Liver Specialists
Allentown, Pennsylvania, United States, 18104
Contact: Adam Peyton, Site 0012
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
Contact: Thomas Sepe, Site 0017
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Contact: Reem Ghalib, Site 0009
Methodist Transplant Physicians
Dallas, Texas, United States, 75203
Contact: Parvez Mantry, Site 0020
Texas Liver Institute
San Antonio, Texas, United States, 78215
Contact: Fred Poordad, Site 0013
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22031
Contact: James Cooper, Site 0008
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
Richmond, Virginia, United States, 23226
Contact: Mitchell Shiffman, Site 0016
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0003
Local Institution
Edmonton, Alberta, Canada, T6G 2G3
Contact: Site 0005
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Contact: Site 0004
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Contact: Site 0001
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2C4
Contact: Site 0007
Canada, Quebec
Local Institution Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Site 0002
Canada
Local Institution Recruiting
Regina Saskatchewan, Canada, S4O 0W5
Contact: Site 0006

Research
Of Interest
Aim
To assess the comparative effectiveness of ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ± RBV) vs. ombitasvir/paritaprevir/ritonavir + dasabuvir (OPrD) ± RBV in genotype 1 HCV patients treated in routine medical practice.
Read more....

Video
Viekirax (ombitasvir/parataprevir/ritonavir, and Exviera (dasabuvir)
Real-world experience with 3-D regimen lives up to phase 3 studies
BARCELONA — In this video perspective from the International Liver Congress 2016, Heiner Wedemeyer, MD, research group leader, department of gastroenterology, hepatology and endocrinology at Hannover Medical School in Germany, discusses his real-world experience with the German Hepatitis C-Registry. Specifically, Wedemeyer looked at the impact of Viekirax (ombitasvir/parataprevir/ritonavir, AbbVie) and Exviera (dasabuvir, AbbVie), together known as Viekira Pak in the United States, in his own practice, showing that the everyday impact is similar to that seen in phase 3 trials.

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02581189
Contacts
Contact: Nabil Ackad, MD 514-832-7439 nabil.ackad@abbvie.com
Contact: Catherine Pinsonnault, BS 514-832-7015 catherine.pinsonnault@abbvie.com
Locations
Canada

Condition: Chronic Hepatitis C
Intervention:

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02615145
Locations
Germany
Condition: Chronic Hepatitis C

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02636608
Locations
Hungary
Condition: Chronic Hepatitis C

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02798315
Locations
Kuwait
Condition: Chronic Hepatitis C

Recruiting
Please refer to this study by its ClinicalTrials.gov identifier: NCT02618928
Locations
France
Condition: Chronic Hepatitis C

Not Recruiting Yet
This study is not yet open for participant recruitment
Please refer to this study by its ClinicalTrials.gov identifier: NCT02783976
Contacts - Locations
Contact: 334-1685 Gilead Study Team GS-US-334-1685@gilead.com
Condition: HCV Infection Intervention: Drug: SOF Sponsor: Gilead Sciences
verified May 2016 (Source: ClinicalTrials.gov)
May 24, 2016

Not Recruiting Yet
Drug: sofosbuvir/ledipasvir; Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: elbasvir/grazoprevir
This study is not yet open for participant recruitment
Please refer to this study by its ClinicalTrials.gov identifier: NCT02781571
Contacts
Contact: Gilead Study Team 342-2104alerts@gilead.com  
Condition: Chronic Hepatitis C Interventions
Drug: sofosbuvir/ledipasvir; Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: elbasvir/grazoprevir
Sponsors: University of North Carolina, Chapel Hill; Patient-Centered Outcomes Research Institute; Merck Sharp & Dohme Corp.; AbbVie - verified May 2016 (Source: ClinicalTrials.gov)
Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Contact: Leila Bucary Leila.Bucary@gunet.georgetown.edu
Principal Investigator: Coleman Smith, MD
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Diane White, CCRP 734-763-6647 dfwhite@umich.edu
Principal Investigator: Anna SF Lok, MD
United States, Minnesota
Minnesota Gastro
Minneapolis, Minnesota, United States, 55455
Contact: Teri Carlson 612-625-0673 carls273@umn.edu
Principal Investigator: Coleman Smith, MD
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact: Mahado Ali, RN 612-626-1716 alixx639@umn.edu
Principal Investigator: Mohamed Hassan, MD
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
Contact: Karri L Moore 314-977-9400 kmoore35@slu.edu
Principal Investigator: Adrian DiBisceglie, MD
United States, Nebraska
University of Nebraska Medical Ctr
Omaha, Nebraska, United States, 68105
Contact: Mary Capadano 402-559-3652 mcapadano@unmc.edu
Principal Investigator: Mark Mailliard, MD
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
Contact: Christopher Gallegos 505-216-1546 cgallegos@southwestcare.org
Principal Investigator: Trevor N Hawkins, MD
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Jennie Chavis 212-305-3839 jc4380@cumc.columbia.edu
Principal Investigator: Elizabeth Verna, MD
United States, North Carolina
University of North Carolina at Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Tiffany Pritchett, B.A. tpritch@med.unc.edu
Principal Investigator: Michael W. Fried, M.D
Duke University Medical Center
Durham, North Carolina, United States, 27710
Contact: Loranda Ross 919-681-2941 loranda.ross@duke.edu
Principal Investigator: Anrdrew Muir, MD
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Contact: Susan Sibert, RN, CCRC 513-584-2363 susan.sibert@uc.edu
Principal Investigator: Kenneth Sherman, MD
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Amina Wirjosemito 215-615-5471 Amina.Wirjosemito@uphs.upenn.edu
Principal Investigator: Rajender Reddy, MD
United States, Texas
Research Specialist of Texas
Houston, Texas, United States, 77030
Contact: Paula Juarez 713-634-5110 pjuarez@texasliver.com
Principal Investigator: Joseph Galati, MD
United States, Virginia
Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)
Richmond, Virginia, United States, 23226
Contact: Susan Vollum, RN, CRC 804-977-8921 susan_vollum@bshsi.org
Principal Investigator: Mitchell L. Shiffman, MD

Additional Clinical Information

Downloadable slideset
Regimens for treating genotype 2, 3, 4, 5, or 6 HCV infection
New At Clinical Care Options
Non–Genotype 1 HCV Now and in the Near Future
Posted June 9
In this downloadable slideset, Jordan J. Feld, MD, MPH, and Andrew J. Muir, MD, review current and emerging regimens for treating patients with genotype 2, 3, 4, 5, or 6 HCV infection.
Download slides here, view all updates here...

** Free registration required

Watch
Advances in Chronic Hepatitis C: Management and Treatment

Review will feature four HCV experts reviewing and discussing key presentations on chronic hepatitis C presented at EASL 2016. The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.
LAUNCH ON-DEMAND PROGRAM

Best of viral hepatitis at ILC2016
April 23

Video Link
In this video, Pr. Jean-Michel Pawlotsky and Pr. Thomas Berg review and discuss the “Best of viral hepatitis at ILC2016”. An extensive summary of the latest advances in the fields of hepatitis B and hepatitis C is covered

      

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