AzTrials
AzTrials

Chronic Hepatitis C InfectionPhase 2NCT01225380

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

A Phase 2 study testing GS-9190, GS-9256 and Pegasys® in people with Chronic Hepatitis C Infection, run by Gilead Sciences at 114 sites in 11 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 response-guided duration of therapy with GS-9190 and GS-9256 in combination 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
Chronic Hepatitis C Infection
What is being tested?
GS-9190, GS-9256 and Pegasys®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
114 sitesin 11 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 ALT, 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

114 sites in 11 countries.

114 sites in 11 countries

United States36 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • The North Texas Research Institute

    Arlington, Texas, 76012

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • Emory University, Infectious Disease Clinic

    Atlanta, Georgia, 30308

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 39090

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • 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

  • North Shore University Hospital

    Great Neck, New York, 11021

  • Indiana University

    Indianapolis, Indiana, 46202

  • Scripps Clinic

    La Jolla, California, 92037

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • University of Miami Center for Liver Diseases

    Miami, Florida, 33136

  • Concorde Medical Group

    New York, New York, 10016

  • Cornell University Gastroenterology & Hepatology

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Liver Institute of Virginia, Bon Secours

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Medical Associates Research Group

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92154

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Southwest CARE Center

    Santa Fe, New Mexico, 87505

  • Bach and Godofsky Infectious Diseases

    Sarasota, Florida, 34243

  • Virginia Mason Medical Center, Digestive Disease Institute

    Seattle, Washington, 98101

Other trials in United States

Poland14 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 Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia

    Czeladź, 41-250

  • Wojewodzki Szpital Zespolony w Kielcach

    Kielce, 25-736

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • 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 Wojewodzki Szpital Zespolony w Szczecinie

    Szczecin, 71-455

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

    Warsaw, 01-201

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X

    Warsaw, 01-201

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

    Warsaw, 02-507

  • EMC Instytut Medyczny S.A.

    Wroclaw, 50-220

Other trials in Poland

Germany11 sites

  • Charite University Medicine

    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

  • Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH

    Hamburg, 20099

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • University hospital Heidelberg

    Heidelberg, 69120

  • University Hospital Leipzig

    Leipzig, 04103

  • Johannes Gutenberg University Hospital

    Mainz, 55131

  • Ludwig-Maximilians-University Munich

    München, 81377

Other trials in Germany

Canada10 sites

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4N1

  • University of Alberta, Division of Gastroenterology

    Edmonton, Alberta, T6G 2C2

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Ottawa Hospital, Division of Infectious Diseases

    Ottawa, Ontario, K1H 8L6

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Downtown ID Clinic

    Vancouver, British Columbia, V3S 4N9

  • Gordon & Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 3P1

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • John Buhler Research Centre

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

United Kingdom9 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • North Manchester General Hospital

    Greater Manchester, M8 5RB

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP UK

  • Barts and The London Hospital

    London, E1 2AT

  • University College London Hospital

    London, NW1 2BU

  • Kings College Hospital

    London, SE5 9RS

  • Chelsea and Westminster Hospital

    London, SW109NH

  • Institute of Cellular Medicine (Hepatology)

    Newcastle upon Tyne, NE24HH

  • Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

Czechia6 sites

  • University Hospital Brno

    Brno, 625 00

  • Melnik Hospital

    Mělník, 276 01

  • University Hospital Plzen

    Pilsen, 304 60

  • Klinmed, s.r.o.

    Prague, 128 00

  • Institute of Clinic and Experimental Medicine

    Prague, 140 21

  • Association of Physicians for Infection Diseases

    Ústí nad Labem, 477 01

Other trials in Czechia

France6 sites

  • Beaujon Hospital

    Clichy, 92110

  • Henri Mondor Hospital

    Créteil, 94000

  • Claude Huriez Hospital

    Lille, 59000

  • Hotel Dieu Hospital

    Lyon, 69002

  • Saint Joseph Hospital

    Marseille, 13008

  • Nancy University Hospital Center

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Italy6 sites

  • Epatologia, Azienda Ospedaliero "Spedali Civili"

    Brescia, 25123

  • U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Medicina Generale - Azienda Ospedaliera di Padova

    Padova, 35128

  • U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria

    Parma, 43100

  • Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista

    Torino, 10126

Other trials in Italy

Spain6 sites

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clínico Universitario San Cecilio

    Granada, 18012

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Universitario Ntra. Sra. de Valme

    Seville, 41014

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Austria5 sites

  • 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

  • SGS - Clinical Pharmacology Unit Antwerpen

    Antwerp, 2060

  • ULB Erasme

    Brussels, 1070

  • UCL Saint Luc

    Brussels, 1200

  • UZ Antwerp

    Edegem, 2650

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

About this study

Official title: 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.

Being tested
GS-9190, GS-9256, Pegasys®, Copegus®, GS-9190 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-9256
Medical subject headings
Hepatitis C

What participants receive

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

  • GS-9190Drug

    GS-9190 capsule, 20 mg BID, 16 or 24 weeks

  • GS-9256Drug

    GS-9256 capsule, 150 mg BID, 16 or 24 weeks

  • Pegasys®Biological

    peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks

  • Copegus®Drug

    ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks

  • GS-9190 placeboDrug

    placebo matching GS-9190 capsule BID, 24 weeks

  • GS-9256Drug

    GS-9256 capsule, 150 mg BID, 24 weeks

  • Pegasys®Biological

    peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks

  • Copegus®Drug

    ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks

  • GS-9190 placeboDrug

    placebo matching GS-9190 capsule BID, 24 weeks

  • GS-9256 placeboDrug

    placebo matching GS-9256 capsule BID, 24 weeks

  • Pegasys®Biological

    peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks

  • Copegus®Drug

    ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks

Study groups in NCT01225380
Study groupRoleWhat they receive
Arm 1ExperimentalGS-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
Receives: Drug: GS-9190; Drug: GS-9256; Biological: Pegasys®; Drug: Copegus®
Arm 2ExperimentalGS-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
Receives: Drug: GS-9190 placebo; Drug: GS-9256; Biological: Pegasys®; Drug: Copegus®
Arm 3Placebo comparatorPlacebo 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
Receives: Drug: GS-9190 placebo; Drug: GS-9256 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 (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation

    Measured: 24 weeks of off-treatment follow-up

Secondary outcomes (4)

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

    Measured: Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up

  2. Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256

    Measured: 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

  3. 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

    Measured: Through Week 4 of therapy

  4. Long-term assessment of plasma HCV RNA in subjects who achieve SVR

    Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72.

    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 posted21 Oct 2010 (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
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01225380
Sponsor's protocol ID
GS-US-196-0123
Status last verified
Dec 2013
First submitted
18 Oct 2010
Last updated
28 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GS-9190, GS-9256 and Pegasys® in people with Chronic Hepatitis C Infection, run by Gilead Sciences at 114 sites in 11 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Poland, Germany, Canada, United Kingdom and 6 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 (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation (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 NCT01225380.

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 28 Jan 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in