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Chronic Hepatitis CPhase 3NCT01625338

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

A Phase 3 study testing SOF, RBV and Peg-IFN in people with Chronic Hepatitis C, run by Gilead Sciences at 175 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
SOF, RBV and Peg-IFN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
534 participants
Where
175 sitesin 16 countries
Study dates
Jun 2012to Dec 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

175 sites in 16 countries.

175 sites in 16 countries

United States67 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Clinical Study Center of Asheville, LLC

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates, LLC

    Atlanta, Georgia, 30308

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Franco Felizarta, MD

    Bakersfield, California, 93301

  • Digestive Disease Associates, PA

    Baltimore, Maryland, 21229

  • Binghamton Gastroenterology Associates, PC

    Binghamton, New York, 13903

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases

    Bradenton, Florida, 34209

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Arrowhead Regional Medical Center

    Colton, California, 92324

  • Southern California Transplantation Institute, Research Foundation Liver Center

    Coronado, California, 92118

  • Annette C. and Harold C. Simmons Transplant Center

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Florida

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee, 38138

  • ID Care, Inc.

    Hillsborough, New Jersey, 08844

  • Research Specialists of Texas

    Houston, Texas, 77030

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Kansas City Gastroenterology and Hepatology

    Kansas City, Missouri, 64131

  • eStudy Site

    La Mesa, California, 91942

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Lightsource Medical/Peter J. Ruane MD, Inc.

    Los Angeles, California, 90036

  • California Liver Institute

    Los Angeles, California, 90048

  • Anthony Mills MD, Inc.

    Los Angeles, California, 90069

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Gastointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • University of Miami Center for Liver Diseases

    Miami, Florida, 33136

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37211

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Bon Secours Saint Mary's Hospital of Richmond

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Orlando Clinical

    Novi, Michigan, 48377

  • eStudySite

    Oceanside, California, 92056

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Minnesota Gastroenterology, P.A.

    Saint Paul, Minnesota, 55114

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • University of California

    San Diego, California, 92103

  • Resarch and Education, Inc.

    San Diego, California, 92105

  • Medical Associates Research Group

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92154

  • Quest Clinical Research

    San Francisco, California, 94115

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Infectious Disease and The Research Institute

    Springfield, Massachusetts, 01105

  • Carolinas Center for Liver Disease

    Statesville, North Carolina, 28677

  • AGA Clinical Research Associates, LLC

    Township, New Jersey, 08234

  • Advanced Research Institute

    Trinity, Florida, 34655

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • Whitman-Walker Health

    Washington D.C., District of Columbia, 20009

  • South Florida Center of Gastroenterology, PA.

    Wellington, Florida, 33414

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany16 sites

  • Leber- und Studienzentrum am Checkpoint

    Berlin, 10969

  • Campus Virchow Klinikum

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

    Frankfurt am Main, 60590

  • PraxisZentrum für Gastroenterologie und Endokrinologie

    Freiburg im Breisgau, 79098

  • Asklepios Klinik Sankt Georg Hamburg

    Hamburg, 20099

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten

    Heidelberg, 69120

  • Gastroenterologische Gemeinschaftspraxis

    Herne, 44623

  • Leberstudienzentrum Kiel

    Kiel, 24146

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Klinikum der Universität München

    Munich, 81377

  • Centrum fur Interdisziplinare Medizin

    Münster, 48143

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Australia15 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Canberra Hospital

    Australian Capital Territory, 2605

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St. Vincent's Hospital

    Fitzroy, 3065

  • B2 Clinic

    Fremantle, Western Australia, 6160

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland, 4120

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane & Women's Hospital

    Herston, QLD 4029

  • St George Hospital

    Kogarah, 2217

  • Monash Medical Centre

    Melbourne, Victoria, 3168

  • Royal Prince Alfred Hospital, Camperdown

    NSW, 2050

  • Royal Perth Hospital

    Perth Western Australia, 6000

  • Princess Alexandra Hospital

    State of Queensland, 4102

  • Box Hill Hospital

    Victoria, 3128

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

France14 sites

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63003

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hôpital Beaujon

    Clichy, 92110

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

    Lille, 59037

  • Hôpital Saint Joseph

    Marseille, 13285

  • Hopital Saint Eloi

    Montpellier, 34295

  • Service Hepatologie

    Nice, 06200

  • Hôpital Saint-Antoine

    Paris, 75571

  • Groupe Hospitalier Pitié-Salpétrière

    Paris, 75651

  • Hôpital Haut-Lévêque, CHU Bordeaux

    Pessac, 33604

  • Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg, 67091

  • Hopital de I'Archet 2

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada12 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Hopital St. Luc

    Montreal, Quebec, H2X 3J4

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Toronto Western Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Vancouver Infectious Disease Research and Care Centre

    Vancouver, British Columbia, V6Z 2C7

  • Gastrointestinal Research Institute (GIRI)

    Vancouver, British Columbia, V6Z 2K5

  • Gordon & Leslie Diamond Health Care Centre

    Vancouver, BC V5Z 1M9

  • Toronto Digestive Diseases Associates, Inc

    Vaughan, Ontario, L4L 4Y7

  • John Buhler Research Center

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

Italy10 sites

  • Ospedale S. Annunziata

    Florence, 50011

  • Ente Ospedaliero Ospedali Galliera di Genova

    Genoa, 16128

  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda

    Milan, 20162

  • Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera de Padova

    Padova, 35128

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • Fondazione PTV - Policlinico Tor Vergata

    Roma, 00133

  • I.N.M.I L. Spallanzani IRCCS

    Rome, 00149

  • Casa Sollievo della Sofferenza Hospital

    San Giovanni Rotonda, Foggia, 71013

  • Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino

    Turin, 10126

Other trials in Italy

United Kingdom9 sites

  • University of Birmingham

    Birmingham, B15 2TH

  • Southampton University Hospital

    Hampshire, SO16 6YD

  • London Royal Hospital, GHU

    London, E1 1BB

  • King's College Hospital

    London, SE5 9RS

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, SW10 9NH

  • Royal Free Hospital and University College London Hospital

    London, UK NW3 2QG

  • North Manchester General Hospital

    Manchester, M8 5RB

  • Nottingham University Hospitals-NHS

    Nottingham, NG7 2UH

  • The Liver Unit

    Paddington, London, W2 1NY

Other trials in United Kingdom

New Zealand7 sites

  • Auckland City Hospital

    Auckland, 11142

  • Christchurch Hospital

    Christchurch, Christchurch, 8011

  • Dunedin Hospital

    Dunedin, 9016

  • Auckland Clinical Studies

    Grafton, Auckland, 1010

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, WGN, 6021

  • Tauranga Hospital

    Tauranga, BOP, 3143

Other trials in New Zealand

Spain7 sites

  • Hospital Casa de la Maternidad

    Barcelona, 08036

  • Hospital Vall d'Hebron

    Barcelona, 8035

  • Hospital Carlos III

    Madrid, 28029

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28220

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

  • Hospital General Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Poland5 sites

  • Klinika Chorob Zakaznych i Hep

    Bialystok, 15-540

  • Oddzial Kliniczny Chorob Zakaznych

    Chorzów, 41-500

  • WSSzpital im.Dr.Wj.Bieganskieg

    Lodz, 91-347

  • ID Clinic

    Mysłowice, 41-400

  • Sp Zoz Wojewódzki Szpital

    Warsaw, 01-201

Other trials in Poland

Austria3 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Medizinische Universität Wien

    Vienna, 1090

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Netherlands3 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Radboud University Nijmegen Medical Centre (UMC St Radboud)

    Nijmegen, 6525 GA

  • Academic Hospital Rotterdam Erasmus Medical Center

    Rotterdam, 3015 CE

Other trials in Netherlands

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41685

  • Skånes Universitetssjukhus, Malmö

    Malmö, 20502

  • Karolinska University Hospital Huddinge

    Stockholm, 141 86

Other trials in Sweden

Estonia2 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Czechia1 site

  • Remedis s.r.o., Nestátní zdravotnické zarízení

    Prague

Other trials in Czechia

Puerto Rico1 site

  • Fundacion De Investigacion De Diego

    San Juan, PR, 927

Other trials in Puerto Rico

About this study

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

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).

Being tested
SOF, RBV, Peg-IFN
Keywords
HCV genotype 2 (GT-2), HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, Ribavirin, Open Label
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOFDrug

    Also called Sovaldi®, GS-7977, PSI-7977

    SOF 400 mg tablet administered orally once daily

  • RBVDrug

    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-IFNDrug

    Peg-IFN 180 μg administered once weekly by subcutaneous injection

Study groups in NCT01625338
Study groupRoleWhat they receive
SOF+RBV 12 WeeksExperimentalSOF+RBV for 12 weeks
Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 WeeksExperimentalSOF+RBV for 24 weeks
Receives: Drug: SOF; Drug: RBV
SOF+RBV+Peg-IFN 12 WeeksExperimentalSOF+RBV+Peg-IFN for 12 weeks
Receives: Drug: SOF; Drug: RBV; Drug: Peg-IFN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Measured: Up to 24 weeks

Secondary outcomes (3)

  1. 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.

    Measured: Posttreatment Weeks 4 and 24

  2. 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)

    Measured: Up to 24 weeks

  3. 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.

    Measured: Up to Posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01625338
Sponsor's protocol ID
GS-US-334-0109
Other IDs
2012-000571-16
Status last verified
Oct 2015
First submitted
7 Jun 2012
Last updated
9 Nov 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF, RBV and Peg-IFN in people with Chronic Hepatitis C, run by Gilead Sciences at 175 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Germany, Australia, France, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.

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Clinical Trial NCT01625338 | AzTrials