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AzTrials

Hepatitis C, ChronicPhase 2NCT01271790

A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

A Phase 2 study testing Tegobuvir (GS-9190), GS-9451 and Pegasys® in people with Hepatitis C, Chronic, run by Gilead Sciences at 144 sites in 8 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 phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Tegobuvir (GS-9190), GS-9451 and Pegasys®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
245 participants
Where
144 sitesin 8 countries
Study dates
Oct 2010to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects 18 to 70 years of age
  • Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
  • Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
  • Monoinfection with HCV genotype 1a or 1b
  • HCV treatment-naïve
  • Body mass index (BMI) between 18 and 36 kg/m2
Show all 9Show fewer
  • Creatinine clearance ≥ 50 mL/min
  • Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
  • Screening laboratory values within defined thresholds for alanine aminotransferase (ALT), aspartate aminotransferase (AST), leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

Who cannot join

  • Autoimmune disease
  • Decompensated liver disease or cirrhosis
  • Poorly controlled diabetes mellitus
  • Severe psychiatric illness
  • Severe chronic obstructive pulmonary disease (COPD)
  • Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
Show all 13Show fewer
  • Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
  • History of hemoglobinopathy
  • Known retinal disease
  • Subjects who are immunosuppressed
  • Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
  • Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
  • Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening

Trial locations and contacts

144 sites in 8 countries.

144 sites in 8 countries

United States85 sites

  • UNM Health Sciences Center

    Albuquerque, New Mexico, 87106

  • The North Texas Research Institute

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Emory University, Infectious Disease Clinic

    Atlanta, Georgia, 30308

  • Liver Center of Atlanta

    Atlanta, Georgia, 30309

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Digestive Disease Associates, PA

    Baltimore, Maryland, 21229

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • Binghamton Gastroenterology

    Binghamton, New York, 13903

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Bach and Godofsky Infectious Diseases

    Bradenton, Florida, 34209

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • eStudySite

    Chula Vista, California, 91911

  • Consultants for Clinical

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8887

  • Dekalb Gastroenterology

    Decatur, Georgia, 30033

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • South Denver Gastroenterology

    Englewood, Colorado, 80110

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • University of Florida

    Gainesville, Florida, 32610

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • Palmetto Research

    Hialeah, Florida, 33016

  • ID Care 105

    Hillsborough, New Jersey, 08844

  • Kelsey Research Foundation

    Houston, Texas, 77005

  • Advanced Liver Therapies

    Houston, Texas, 77030

  • Research Specialists of Texas

    Houston, Texas, 77030

  • Amcare Research Inc.

    Houston, Texas, 77090

  • Indiana University

    Indianapolis, Indiana, 46202

  • IGRF

    Indianapolis, Indiana, 46237

  • Gastrointestinal Associates, PA

    Jackson, Mississippi, 39202

  • Scripps Clinic

    La Jolla, California, 92037

  • eStudySite

    La Mesa, California, 91942

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • University of Miami

    Miami, Florida, 33136

  • Alabama Liver and Digestive Specialists

    Montgomery, Alabama, 36116

  • Atlantic Research Affiliates, LLC

    Morristown, New Jersey, 07960

  • James H. Quillen VA Medical Center

    Mountain Home, Tennessee, 37684

  • Columbia Medical Group, The Frist Clinic

    Nashville, Tennessee, 37203

  • Synergy Clinical Research Center

    National City, California, 91950

  • Concorde Medical Group

    New York, New York, 10016

  • NYU Hepatology Associates

    New York, New York, 10016

  • Cornell University Gastroenterology & Hepatology

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Medicine and Dentistry of New Jersey

    Newark, New Jersey, 07103

  • Liver Institute of Virginia, Bon Secours

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research

    North Miami, Florida, 33161

  • Henry Ford Health System-Columbus center

    Novi, Michigan, 48377

  • eStudySite

    Oceanside, California, 92056

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Florida Hospital

    Orlando, Florida, 32804

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • MN Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Brooke Army Medical Center

    San Antonio, Texas, 78234

  • RESEARCH and EDUCATION, INC

    San Diego, California, 92015

  • Medical Associates Research Group

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92154

  • California Pacific Medical Center

    San Francisco, California, 94115

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121

  • Virginia Mason Medical Center, Digestive Disease Institute

    Seattle, Washington, 98101

  • Saint Louis University

    St Louis, Missouri, 63104

  • University of Arizona

    Tucson, Arizona, 85724

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Digestive Health Specialists, PA

    Tupelo, Mississippi, 38801

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • South Florida Center of Gastroenterology, LLC

    Wellington, Florida, 33414

  • Partners in Internal Medicine, P.C.

    Worcester, Massachusetts, 01608

Other trials in United States

Poland12 sites

  • Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

    Bialystok, 15-540

  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

    Bydgoszcz, 85-030

  • Szpital Specjalistyczny w Chorzowie

    Chorzów, 41-500

  • Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o.

    Czeladź, 41-250

  • Wojewodzki Szpital Zespolony w Kielcach

    Kielce, 25-317

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 31-531

  • Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

    Lodz, 91-347

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, 20-081

  • Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

    Radom, 26-610

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

    Warsaw, 01-201

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

    Warsaw, 02-507

  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

    Wroclaw, 51-149

Other trials in Poland

Germany11 sites

  • Charite University Medicine

    Berlin, 13353

  • Leber- und Studienzentrum am Checkpoint

    Berlin, 13353

  • University Hospital Bonn

    Bonn, 53105

  • University Hospital Essen

    Essen, 45122

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt/M, 60590

  • University Hospital Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Klinik Sankt Georg

    Hamburg, 20099

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • University hospital Heidelberg

    Heidelberg, 69120

  • University Hospital Leipzig

    Leipzig, 04103

  • Johannes Gutenberg University Hospital

    Mainz, 55131

Other trials in Germany

United Kingdom11 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP UK

  • Barts and The London Hospital

    London, E1 2AT

  • Royal Free Hospital

    London, NW1 2BU

  • Kings College Hospital

    London, SE5 9RS

  • Chelsea and Westminster Hospital

    London, SW10 9NH

  • Saint Mary's Hosptial

    London, W2 1NY

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • North Manchester General Hospital

    Manchester, M8 5RB

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

France10 sites

  • Beaujon Hospital

    Clichy, 92110

  • Henri Mondor Hospital

    Créteil, 94010

  • Hôpital de la Croix Rousse

    Lyon, 69004

  • Saint Joseph Hospital

    Marseille, 13285

  • Hôpital de I´Archet 2, Service Hépatologie

    Nice, 06200

  • Centre Hospitalier Régional d'Orléans, Hôpital de la Source

    Orléans, 45067

  • Hôpital Cochin

    Paris, 75679

  • Groupe Hospitalier du Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil

    Strasbourg, 67091

  • Nancy University Hospital Center

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Austria6 sites

  • Landeskrankenhaus Graz West

    Graz, 8020

  • Medizinische Universität Graz

    Graz, 8036

  • LKH Innsbruck

    Innsbruck, 6020

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4020

  • AKH der Stadt Wien

    Vienna, 1090

  • Wilhelminenspital der Stadt Wien

    Vienna, 1171

Other trials in Austria

Belgium5 sites

  • Ziekenhuis Netwerk Antwerpen

    Antwerp, 2060

  • ULB Erasme

    Brussels, 1070

  • UCL Saint Luc

    Brussels, 1200

  • UZ Antwerp

    Edegem, 2650

  • Centre Hospitalier Universitaire Sart Tilman Liège

    Liège

Other trials in Belgium

Netherlands4 sites

  • Academisch Medisch Centrum Universiteit Van Amsterdam

    Amsterdam, 1105 AZ

  • Radaboud University Nijmegen Medical Centre (UMC St Radboud)

    Nijmegen, 6525 GA

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015 GD

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

Being tested
Tegobuvir (GS-9190), GS-9451, Pegasys®, Copegus®, Tegobuvir placebo
Keywords
Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, HCV RNA, Polymerase inhibitor, Protease inhibitor, Treatment naïve, GS-9190, GS-9451
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

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

  • Tegobuvir (GS-9190)Drug

    Tegobuvir (GS-9190) capsule, 30 mg BID

  • GS-9451Drug

    GS-9451 tablet, 200 mg once daily (QD)

  • Pegasys®Biological

    peginterferon alfa-2a (solution for injection) 180 µg/week

  • Copegus®Drug

    ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

  • GS-9451Drug

    GS-9451 tablet, 200 mg QD

  • Tegobuvir placeboDrug

    placebo matching Tegobuvir (GS-9190) capsule BID

  • Pegasys®Biological

    peginterferon alfa-2a (solution for injection) 180 µg/week

  • Copegus®Drug

    ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

  • Tegobuvir placeboDrug

    placebo matching Tegobuvir (GS-9190) capsule BID

  • GS-9451 placeboDrug

    placebo matching GS-9451 tablet QD

  • Pegasys®Biological

    peginterferon alfa-2a (solution for injection) 180 µg/week

  • Copegus®Drug

    ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet

Study groups in NCT01271790
Study groupRoleWhat they receive
Arm 1Active comparatorGS-9451 and Tegobuvir (GS-9190) in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy
Receives: Drug: Tegobuvir (GS-9190); Drug: GS-9451; Biological: Pegasys®; Drug: Copegus®
Arm 2Active comparatorGS-9451 (active) and Tegobuvir (GS-9190) placebo in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy
Receives: Drug: GS-9451; Drug: Tegobuvir placebo; Biological: Pegasys®; Drug: Copegus®
Arm 3Placebo comparatorPlacebo matching Tegobuvir (GS-9190) and GS-9451 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration
Receives: Drug: Tegobuvir placebo; Drug: GS-9451 placebo; Biological: Pegasys®; Drug: Copegus®

What is being measured

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

  1. Sustained virologic response

    Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation

    Measured: 24 weeks of off-treatment follow-up

Secondary outcomes (4)

  1. Safety and tolerability of therapy

    Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events

    Measured: Through treatment period and 24 weeks of off-treatment follow-up

  2. Emergence of viral resistance following initiation of therapy with GS 9190 and GS 9451

    Measured: Through treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy

  3. Viral dynamics and steady state pharmacokinetics

    Viral dynamics and steady state pharmacokinetics of GS 9190 and GS 9451 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9451 over time

    Measured: Through Week 4 of therapy

  4. Durability of response in subjects who achieve SVR

    Measured: 36 months following Week 72

Timeline

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

  1. First posted7 Jan 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionJan 2013
  4. Study completionSep 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01271790
Sponsor's protocol ID
GS-US-196-0140
Status last verified
Jan 2014
First submitted
5 Jan 2011
Last updated
6 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tegobuvir (GS-9190), GS-9451 and Pegasys® in people with Hepatitis C, Chronic, run by Gilead Sciences at 144 sites in 8 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 9 inclusion and 13 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Poland, Germany, United Kingdom, France and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sustained virologic response (time frame: 24 weeks of off-treatment follow-up). 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 NCT01271790.

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 6 Feb 2014.

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