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Hepatitis CPhase 3NCT01682720

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

A Phase 3 study testing SOF and RBV in people with Hepatitis C, run by Gilead Sciences at 77 sites in 10 countries.

Completed

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

Official record
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Trial summary

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
SOF and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
77 sitesin 10 countries
Study dates
Sep 2012to Jan 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

  • Age > 18 with chronic genotype 2 or 3 HCV infection
  • HCV RNA > 10,000 IU/mL at screening
  • Subjects must be treatment naive or treatment experienced
  • Presence or absence of cirrhosis; a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Who cannot join

  • Prior use of any other inhibitor of the HCV NS5B Polymerase
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • HIV or chronic hepatitis B virus (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator

Trial locations and contacts

77 sites in 10 countries.

77 sites in 10 countries

France15 sites

  • CHRU de Lille, Hopital Claude Huriez

    CHRU Lille, 59037

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Henri Mondor

    Créteil, 94000

  • Département Hépatogastroentérologie - CHU de Grenoble

    Grenoble, 38043

  • Hopital Saint Joseph

    Marseille, 13008

  • Hopital Saint Eloi

    Montpellier, 34295

  • Hopital de l Archet 2

    Nice, 6202

  • Hopital Saint Antoine

    Paris, 75012

  • Hopital Pitie Salpetriere

    Paris, 75013

  • Hopitaux Universitaires

    Paris, 75679

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

    Pessac, 33604

  • CHU Pontchaillou - Hématologie Clinique

    Rennes, 35033

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg, 67091

  • CHU de Nancy, Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany14 sites

  • Leber- and Studienzentrum am Checkpoint

    Berlin, 10969

  • Universitaetsklinikum Bonn

    Bonn, 53125

  • Heinrich Heine Unversitat

    Düsseldorf, 40225

  • JWG-Universität Frankfurt

    Frankfurt am Main, 60590

  • Praxiszentrum

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • Asklepios Klinik Sankt Georg H

    Hamburg, 20099

  • Universitatsklinikum

    Hamburg, 20246

  • Medizinische Hochschule Hannov

    Hanover, 30625

  • Medizinische Klinik IV, Dep. o

    Heidelberg, 69120

  • Gastroenterologische Gemeinsch

    Herne, 44623

  • Leberstudienzentrum Kiel

    Kiel, 24146

  • Universitaetsklinikum Leipzig

    Leipzig, 4103

  • Klinikum der Universität Münch

    München, 81377

  • Centrum fuer interdisziplinaere Medizin Muenster GmbH

    Münster, D-48143

Other trials in Germany

Italy12 sites

  • Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Ospedale S. Annunziata

    Florence, 50011

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16128

  • Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Ospedale Niguarda Cà Granda

    Milan, 20162

  • University of Padova

    Padova, 35100

  • University of Palermo

    Palermo, 90127

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43100

  • Fondazione PTV - Policlinico Tor Vergata

    Roma, 133

  • INMI "Lazzaro Spallanzani" I.R.C.C.S.

    Roma, 149

  • Ospedale Casa Sollievo

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliera Universitaria San Giovanni Battista di Torino

    Torino, 10126

Other trials in Italy

United Kingdom10 sites

  • Bristol Royal Infirmary

    Bristol, BS2 8HW

  • North Manchester General Hospital

    Crumpsall, Manchester, M8 5RB

  • King's College Hospital

    Denmark Hill, London, SE5 9RS

  • University of Birmingham

    Edgbaston, Birmingham, B15 2TH

  • Queen Marys University of London

    London, E1 2AT

  • Royal Free Hospital and University College London Hospital

    London, NW3 2PF

  • Chelsea & Westminster Hospital

    London, SW109NH

  • Nottingham University Hospitals-NHS

    Nottingham, NG7 2UH

  • The Liver Unit

    Paddington, London, W2 1NY

  • Southampton University Hospital NHS Trust

    Southhampton, Hampshire, SO41 3QP

Other trials in United Kingdom

Spain9 sites

  • Hospital Universitari Vall d'H

    Barcelona, 08035

  • Hospital Casa de la Maternidad

    Barcelona, 08036

  • Hospital Carlos III

    Madrid, 28029

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Puerta de Hierro Maja

    Majadahonda, 28222

  • Complejo Hospitalario de Especialidades Virgen de la Victoria

    Málaga, 29071

  • Hospital Universitario Marques

    Santander, 39008

  • Valme Hospital

    Seville, 41014

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Netherlands4 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum

    Leiden, 2300 RC

  • UMC St. Radboud - Gastroenterology

    Nijmegen, 6500 HB

  • Erasmus MC

    Rotterdam, 3015 CE

Other trials in Netherlands

Poland4 sites

  • Wojewodzki Szpital Specjalistyczny im Dluskeigo

    Bialystok, 15-540

  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

    Lodz, 91-347

  • SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

    Warsaw, 01-201

  • NZOZ Centrum Badan Klinicznych

    Wroclaw, 50-349

Other trials in Poland

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41685

  • Skånes Universitetssjukhus, Lund

    Lund, 22185

  • Skanes Universitetssjukhus

    Malmö, 20502

  • Karolinska Instituet

    Stockholm, 14186

Other trials in Sweden

Austria3 sites

  • Medizinische Universitat Graz

    Graz, A-8036

  • Medizinische Universitat Wien

    Vienna, 1090

  • Wilhelminenspital

    Vienna, 1160

Other trials in Austria

Estonia2 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Conditions
Hepatitis C
Being tested
SOF, RBV, Placebo to match SOF, Placebo to match RBV
Keywords
HCV, Genotype 2, Genotype 3
Medical subject headings
Hepatitis C

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

    Sofosbuvir (SOF) 400 mg tablet administered orally once daily

  • RBVDrug

    Ribavirin (RBV) 200 mg 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)

  • Placebo to match SOFDrug

    Placebo to match SOF administered orally once daily

  • Placebo to match RBVDrug

    Placebo to match RBV administered orally in a divided daily dose

Study groups in NCT01682720
Study groupRoleWhat they receive
Placebo 12 Weeks (GT2/3)Placebo comparatorPlacebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
Receives: Drug: Placebo to match SOF; Drug: Placebo to match RBV
SOF 12 Weeks (GT2/3)ExperimentalPlacebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
Receives: Drug: SOF; Drug: RBV
SOF 24 Weeks (GT3)ExperimentalSOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
Receives: Drug: SOF; Drug: RBV

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 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

    Measured: Posttreatment Week 12

  2. Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.

    Measured: Up to 24 weeks

Secondary outcomes (2)

  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

    Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.

    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

    Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

    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 posted11 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionOct 2013
  4. Study completionJan 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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01682720
Sponsor's protocol ID
GS-US-334-0133
Other IDs
2012-001942-16
Status last verified
Oct 2014
First submitted
5 Sep 2012
Last updated
9 Oct 2014
Data monitoring committee
Yes

Publications

  • Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.

    PubMed 24795201

  • Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

    PubMed 25583164

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF and RBV in people with Hepatitis C, run by Gilead Sciences at 77 sites in 10 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 6 inclusion and 7 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in France, Germany, Italy, United Kingdom, Spain and 5 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. Some participants in this study may receive a placebo. 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 Oct 2014). 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 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 NCT01682720, which also lists 2 linked publications.

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 Oct 2014.

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