A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

December 20, 2013 updated by: Gilead Sciences

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Innsbruck, Austria, 6020
        • LKH Innsbruck
      • Linz, Austria, 4020
        • Krankenhaus der Elisabethinen Linz GmbH
      • Vienna, Austria, 1090
        • AKH der Stadt Wien
      • Vienna, Austria, 1171
        • Wilhelminenspital der Stadt Wien
  • Belgium
      • Antwerpen, Belgium, 2060
        • SGS - Clinical Pharmacology Unit Antwerpen
      • Brussels, Belgium, 1070
        • ULB Erasme
      • Brussels, Belgium, 1200
        • UCL Saint Luc
      • Edegem, Belgium, 2650
        • UZ Antwerp
      • Liege, Belgium, 4000
        • Chu Sart Tilman
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Heritage Medical Research Clinic
      • Edmonton, Alberta, Canada, T6G 2C2
        • University of Alberta, Division of Gastroenterology
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
      • Vancouver, British Columbia, Canada, V3S 4N9
        • Downtown ID Clinic
      • Vancouver, British Columbia, Canada, V5Z 3P1
        • Gordon & Leslie Diamond Health Care Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • John Buhler Research Centre
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital, Division of Infectious Diseases
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • University Hospital Brno
      • Melnik, Czech Republic, 276 01
        • Melnik Hospital
      • Plzen, Czech Republic, 304 60
        • University Hospital Plzen
      • Prague, Czech Republic, 128 00
        • Klinmed, s.r.o.
      • Prague, Czech Republic, 140 21
        • Institute of Clinic and Experimental Medicine
      • Usti Nad labem, Czech Republic, 477 01
        • Association of Physicians for Infection Diseases
  • France
      • Clichy, France, 92110
        • Beaujon Hospital
      • Créteil, France, 94000
        • Henri Mondor Hospital
      • Lille, France, 59000
        • Claude Huriez hospital
      • Lyon, France, 69002
        • Hotel Dieu Hospital
      • Marseille, France, 13008
        • Saint Joseph Hospital
      • Vandoeuvre, France, 54500
        • Nancy University Hospital Center
  • Germany
      • Berlin, Germany, 13353
        • Charite University Medicine
      • Bonn, Germany, 53105
        • University Hospital Bonn
      • Essen, Germany, 45122
        • University Hospital Essen
      • Frankfurt/M, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universität
      • Freiburg, Germany, 79106
        • University Hospital Freiburg
      • Hamburg, Germany, 20099
        • Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Leipzig, Germany, 04103
        • University Hospital Leipzig
      • Mainz, Germany, 55131
        • Johannes Gutenberg University Hospital
      • München, Germany, 81377
        • Ludwig-Maximilians-University Munich
  • Italy
      • Brescia, Italy, 25123
        • Epatologia, Azienda Ospedaliero "Spedali Civili"
      • Milano, Italy, 20122
        • U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Padova, Italy, 35128
        • Medicina Generale - Azienda Ospedaliera di Padova
      • Palermo, Italy, 90127
        • U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone
      • Parma, Italy, 43100
        • Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria
      • Torino, Italy, 10126
        • Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista
  • Poland
      • Bialystok, Poland, 15-540
        • Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny
      • Bydgoszcz, Poland, 85-030
        • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny
      • Chorzow, Poland, 41-500
        • Szpital Specjalistyczny w Chorzowie
      • Czeladz, Poland, 41-250
        • Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia
      • Kielce, Poland, 25-736
        • Wojewodzki Szpital Zespolony w Kielcach
      • Krakow, Poland, 31-501
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi
      • Lublin, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
      • Radom, Poland, 26-610
        • Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby
      • Szczecin, Poland, 71-455
        • Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
      • Warszawa, Poland, 01-201
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny
      • Warszawa, Poland, 01-201
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X
      • Wroclaw, Poland, 50-220
        • EMC Instytut Medyczny S.A.
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Granada, Spain, 18012
        • Hospital Clinico Universitario San Cecilio
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Sevilla, Spain, 41014
        • Hospital Universitario Ntra. Sra. de Valme
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Greater Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital
      • Liverpool, United Kingdom, L7 8XP UK
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, NW1 2BU
        • University College London Hospital
      • London, United Kingdom, SW109NH
        • Chelsea and Westminster Hospital
      • London, United Kingdom, E1 2AT
        • Barts and The London Hospital
      • Newcastle Upon Tyne, United Kingdom, NE24HH
        • Institute of Cellular Medicine (Hepatology)
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92154
        • Kaiser Permanente
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80110
        • South Denver Gastroenterology
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Miami, Florida, United States, 33136
        • University of Miami Center for Liver Diseases
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Sarasota, Florida, United States, 34243
        • Bach and Godofsky Infectious Diseases
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, United States, 30308
        • Emory University, Infectious Disease Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Southwest CARE Center
    • New York
      • Great Neck, New York, United States, 11021
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • Concorde Medical Group
      • New York, New York, United States, 10021
        • Cornell University Gastroenterology & Hepatology
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Memphis Gastroenterology Group
    • Texas
      • Arlington, Texas, United States, 76012
        • The North Texas Research Institute
      • Dallas, Texas, United States, 39090
        • UT Southwestern Medical Center at Dallas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
      • Newport News, Virginia, United States, 23602
        • Liver Institute of Virginia, Bon Secours
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center, Digestive Disease Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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 ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
GS-9190 and GS-9256 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
Drug: GS-9190
GS-9190 capsule, 20 mg BID, 16 or 24 weeks
Drug: GS-9256
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Biological: Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
Drug: GS-9256
GS-9256 capsule, 150 mg BID, 24 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
Experimental: Arm 2
GS-9256 (active) and placebo matching GS-9190 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
Drug: GS-9256
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Biological: Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
Drug: GS-9256
GS-9256 capsule, 150 mg BID, 24 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
Drug: GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
Placebo Comparator: Arm 3
Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration
Biological: Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
Drug: GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
Drug: GS-9256 placebo
placebo matching GS-9256 capsule BID, 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation
Time Frame: 24 weeks of off-treatment follow-up
24 weeks of off-treatment follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events
Time Frame: Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up
Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up
Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256
Time Frame: Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy
Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy
Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over time
Time Frame: Through Week 4 of therapy
Through Week 4 of therapy
Long-term assessment of plasma HCV RNA in subjects who achieve SVR
Time Frame: 36 months following Week 72
Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72.
36 months following Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Bittoo Kanwar, Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-196-0123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C Infection

Clinical Trials on GS-9190

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe