Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Chronic Hepatitis C Clinical Trial

Official title:

An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625338
• Other study ID #: GS-US-334-0109
• Secondary ID: 2012-000571-16
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2012
• Last updated: October 9, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health CarePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products AgencyItaly: Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santéUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Agencia Española de Medicamentos y Productos SanitariosEstonia: The State Agency of MedicineNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Czech Republic: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Infection with HCV

• Must have participated in a prior Gilead HCV study

• Use of highly effective contraception methods if female of childbearing potential or sexually active male

• Eligible patients include those in the following

• received placebo or Peg-IFN+RBV in a control arm

• previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:

• Sofosbuvir+RBV

• Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Current or prior history of clinical hepatic decompensation

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Chronic use of systemically administered immunosuppressive agents

• Active drug abuse

• Use of any prohibited concomitant medications

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• SOF
SOF 400 mg tablet administered orally once daily
• RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)
• Peg-IFN
Peg-IFN 180 µg administered once weekly by subcutaneous injection

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Canberra Hospital	Australian Capital Territory
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St. Vincent's Hospital	Fitzroy
Australia	B2 Clinic	Fremantle	Western Australia
Australia	Gallipoli Medical Research Foundation	Greenslopes	Queensland
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Royal Brisbane & Women's Hospital	Herston
Australia	St George Hospital	Kogarah
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Royal Prince Alfred Hospital, Camperdown	NSW
Australia	Royal Perth Hospital	Perth Western Australia
Australia	Princess Alexandra Hospital	State of Queensland
Australia	Box Hill Hospital	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universität Wien	Vienna
Austria	Wilhelminenspital	Wien
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hopital St. Luc	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Gastrointestinal Research Institute (GIRI)	Vancouver	British Columbia
Canada	Gordon & Leslie Diamond Health Care Centre	Vancouver
Canada	Vancouver Infectious Disease Research and Care Centre	Vancouver	British Columbia
Canada	Toronto Digestive Diseases Associates, Inc	Vaughan	Ontario
Canada	John Buhler Research Center	Winnipeg	Manitoba
Czech Republic	Remedis s.r.o., Nestátní zdravotnické zarízení	Praha 4
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
France	Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-Ferrand
France	CHU Estaing	Clermont-Ferrand
France	Hôpital Beaujon	Clichy
France	Hôpital Henri Mondor	Creteil Cedex
France	Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie	Lille
France	Hôpital Saint Joseph	Marseille
France	Hopital Saint Eloi	Montpellier
France	Service Hepatologie	Nice
France	Hôpital Saint-Antoine	Paris Cedex 12
France	Groupe Hospitalier Pitié-Salpétrière	Paris Cedex 13
France	Hôpital Haut-Lévêque, CHU Bordeaux	Pessac Cedex
France	Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou	Rennes Cedex 9
France	Centre Hospitalier Universitaire de Strasbourg	Strasbourg
France	Hopital de I'Archet 2	Vandoeuvre-les-Nancy
Germany	Campus Virchow Klinikum	Berlin
Germany	Leber- und Studienzentrum am Checkpoint	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main	Frankfurt am Main
Germany	PraxisZentrum für Gastroenterologie und Endokrinologie	Freiburg im Breisgau
Germany	Asklepios Klinik Sankt Georg Hamburg	Hamburg
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten	Heidelberg
Germany	Gastroenterologische Gemeinschaftspraxis	Herne
Germany	Leberstudienzentrum Kiel	Kiel
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Centrum fur Interdisziplinare Medizin	Muenster
Germany	Klinikum der Universität München	Munich
Germany	Universitatsklinikum Wurzburg	Wurzburg
Italy	Ospedale S. Annunziata	Florence
Italy	Ente Ospedaliero Ospedali Galliera di Genova	Genoa
Italy	Azienda Ospedaliera Ospedale Niguarda Ca' Granda	Milan
Italy	Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera de Padova	Padova
Italy	Azienda Ospedaliero Universitaria di Parma	Parma
Italy	Fondazione PTV - Policlinico Tor Vergata	Roma
Italy	I.N.M.I L. Spallanzani IRCCS	Rome
Italy	Casa Sollievo della Sofferenza Hospital	San Giovanni Rotonda	Foggia
Italy	Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino	Turin
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Radboud University Nijmegen Medical Centre (UMC St Radboud)	Nijmegen
Netherlands	Academic Hospital Rotterdam Erasmus Medical Center	Rotterdam
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Auckland Clinical Studies	Grafton	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Newtown	WGN
New Zealand	Tauranga Hospital	Tauranga	BOP
Poland	Klinika Chorob Zakaznych i Hep	Bialystok
Poland	Oddzial Kliniczny Chorob Zakaznych	Chorzow
Poland	WSSzpital im.Dr.Wj.Bieganskieg	Lodz
Poland	ID Clinic	Myslowice
Poland	Sp Zoz Wojewódzki Szpital	Warsaw
Puerto Rico	Fundacion De Investigacion De Diego	San Juan
Spain	Hospital Casa de la Maternidad	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Carlos III	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitario Nuestra Señora de Valme	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Skånes Universitetssjukhus, Malmö	Malmo
Sweden	Karolinska University Hospital Huddinge	Stockholm
United Kingdom	University of Birmingham	Birmingham
United Kingdom	Southampton University Hospital	Hampshire
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London
United Kingdom	King's College Hospital	London
United Kingdom	London Royal Hospital, GHU	London
United Kingdom	Royal Free Hospital and University College London Hospital	London
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Nottingham University Hospitals-NHS	Nottingham
United Kingdom	The Liver Unit	Paddington	London
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Clinical Study Center of Asheville, LLC	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates, LLC	Atlanta	Georgia
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Franco Felizarta, MD	Bakersfield	California
United States	Digestive Disease Associates, PA	Baltimore	Maryland
United States	Binghamton Gastroenterology Associates, PC	Binghamton	New York
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases	Bradenton	Florida
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Arrowhead Regional Medical Center	Colton	California
United States	Southern California Transplantation Institute, Research Foundation Liver Center	Coronado	California
United States	Annette C. and Harold C. Simmons Transplant Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	South Denver Gastroenterology, PC	Englewood	Colorado
United States	Metropolitan Research	Fairfax	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	Memphis Gastroenterology Group, PC	Germantown	Tennessee
United States	ID Care, Inc.	Hillsborough	New Jersey
United States	Research Specialists of Texas	Houston	Texas
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Kansas City Gastroenterology and Hepatology	Kansas City	Missouri
United States	eStudy Site	La Mesa	California
United States	Anthony Mills MD, Inc.	Los Angeles	California
United States	California Liver Institute	Los Angeles	California
United States	Kaiser Permanente	Los Angeles	California
United States	Lightsource Medical/Peter J. Ruane MD, Inc.	Los Angeles	California
United States	Johns Hopkins University	Lutherville	Maryland
United States	North Shore University Hospital	Manhasset	New York
United States	Gastointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	University of Miami Center for Liver Diseases	Miami	Florida
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Bon Secours Saint Mary's Hospital of Richmond	Newport News	Virginia
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Orlando Clinical	Novi	Michigan
United States	eStudySite	Oceanside	California
United States	Internal Medicine Specialists	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	University of California Davis Medical Center	Sacramento	California
United States	Alamo Medical Research	San Antonio	Texas
United States	Kaiser Permanente	San Diego	California
United States	Medical Associates Research Group	San Diego	California
United States	Resarch and Education, Inc.	San Diego	California
United States	University of California	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Infectious Disease and The Research Institute	Springfield	Massachusetts
United States	Minnesota Gastroenterology, P.A.	St. Paul	Minnesota
United States	Carolinas Center for Liver Disease	Statesville	North Carolina
United States	AGA Clinical Research Associates, LLC	Township	New Jersey
United States	Advanced Research Institute	Trinity	Florida
United States	The Gastroenterology Group of South Jersey	Vineland	New Jersey
United States	Whitman-Walker Health	Washington	District of Columbia
United States	South Florida Center of Gastroenterology, PA.	Wellington	Florida
United States	Digestive Health Specialists, PA	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czech Republic,  Estonia,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Poland,  Puerto Rico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12	No
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks	No
Secondary	Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.	Posttreatment Weeks 4 and 24	No
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as; Breakthrough (confirmed HCV RNA = LLOQ after having previously had HCV RNA < LLOQ while on treatment), or; Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; Non-response (HCV RNA persistently = LLOQ through 8 weeks of treatment)	Up to 24 weeks	No
Secondary	Percentage of Participants With Viral Relapse	Viral relapse was defined as HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.	Up to Posttreatment Week 24	No