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Hepatitis C, ChronicPhase 2NCT01435226

GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

A Phase 2 study testing GS-5885, GS-9451 and tegobuvir in people with Hepatitis C, Chronic, run by Gilead Sciences at 51 sites in 2 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 is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b 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, Chronic
What is being tested?
GS-5885, GS-9451 and tegobuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
51 sitesin 2 countries
Study dates
Sep 2011to Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years with chronic HCV infection
  • Liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
  • Monoinfection with HCV genotype (GT) 1a or 1b
  • HCV RNA ≥ 104 IU/mL at screening
  • Prior treatment and adherence with one course of pegylated interferon alfa and RBV
  • The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
Show all 10Show fewer
  • Body mass index (BMI) 18-40 kg/m2 inclusive
  • Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula)
  • ≤ 450 msec for males and ≤ 470 msec for females.
  • Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

Who cannot join

  • Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up
  • History of significant cardiac disease
  • Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (TSH).
  • Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
  • Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States37 sites

  • Advanced Clinical Research Institute, LLC

    Anaheim, California, 92801

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • California Liver Institute

    Beverly Hills, California, 90211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • SCTI Research Foundation Liver Center

    Coronado, California, 92118

  • Southwest Infectious Disease Clinical Research, Inc

    Dallas, Texas, 75204

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Gastro One

    Germantown, Tennessee, 38138

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • The University of Texas Health Sciences Center at Houston

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California, San Diego

    La Jolla, California, 92161

  • Lightsource Medical

    Los Angeles, California, 90036

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • University of Miami, Center for Liver Diseases

    Miami, Florida, 33136

  • Weill Medical College of Cornell Univeristy

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Bon Secours St. Mary's Hospital of Richmond, Inc.

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Henry Ford Health System

    Novi, Michigan, 48377

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • University of Utah

    Salt Lake City, Utah, 84132

  • Alamo Medical Research, Ltd.

    San Antonio, Texas, 78215

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92154

  • California Pacific Medical Center

    San Francisco, California, 94115

  • San Jose Gastroenterology

    San Jose, California, 95128

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Arizona

    Tucson, Arizona, 85724

  • Whitman Walker Clinic

    Washington D.C., District of Columbia, 20037

Other trials in United States

Germany14 sites

  • Leber- and Studienzentrum am Checkpoint

    Berlin, 10969

  • Charite - Universitatsmedizin Berlin Campus Virchow-Klinikum

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, 53105

  • Center for HIV and Hepatogastroenterology

    Düsseldorf, 40237

  • Klinikum der Johann Wolfgang Goethe Universitaet

    Frankfurt, 60590

  • Medizinische Universitatsklinik

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 22589

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum der Universität Heidelberg

    Heidelberg, 69120

  • Gastroenterologisch-Hepatologisches Zentrum Kiel

    Kiel, 24146

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Johannes Gutenberg University Hospital

    Mainz, 55131

  • Klinikum Innenstadt der LMU Munchen

    München, 81377

  • Universitätsklinikum Würzburg - Med Klinik und Poliklinik

    Würzburg, 97080

Other trials in Germany

About this study

Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared With GS-5885, GS-9451 With Tegobuvir or RBV in Treatment-Experienced Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.

Being tested
GS-5885, GS-9451, tegobuvir, placebo to match tegobuvir, placebo to match RBV
Keywords
Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Treatment Experienced, HCV RNA, Polymerase inhibitor, Protease inhibitor, Interferon intolerant, Interferon ineligible, GS-9190, GS-9451, GS-5885, Chronic Genotype 1a or 1b
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.

  • GS-5885Drug

    Drug: GS-5885 tablet

    GS-5885 tablet, 90 mg, QD

  • GS-9451Drug

    Drug: GS-9451 tablet

    GS-9451 tablet, 200 mg QD

  • tegobuvirDrug

    tegobuvir 30 mg BID

  • placebo to match tegobuvirDrug

    tegobuvir placebo BID

  • placebo to match RBVDrug

    Ribovirin placebo BID

  • RibavirinDrug

    Ribavirin (Copegus®) BID (1000 mg for subjects weighing < 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID

Study groups in NCT01435226
Study groupRoleWhat they receive
Arm 1Active comparatorGS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV BID
Receives: Drug: GS-5885; Drug: GS-9451; Drug: tegobuvir; Drug: Ribavirin
Arm 2Active comparatorGS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV placebo BID
Receives: Drug: GS-5885; Drug: GS-9451; Drug: tegobuvir; Drug: placebo to match RBV
Arm 3Active comparatorGS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir placebo BID + RBV BID
Receives: Drug: GS-5885; Drug: GS-9451; Drug: placebo to match tegobuvir; Drug: Ribavirin

What is being measured

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

  1. Safety and Tolerability

    To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.

    Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.

    Measured: 24 weeks

  2. Antiviral Activity

    To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA < lower limit of quantitation [LLoQ] 24 weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection

    Measured: 24 weeks

Secondary outcomes (3)

  1. Viral Dynamics

    To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.

    Measured: 10 days

  2. Composite (or Profile) of Pharmacokinetics Composite (or Profile) of Pharmacokinetics

    To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½

    Measured: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

  3. Antiviral Efficacy

    To evaluate the antiviral efficacy (as defined by SVR) of adding pegylated interferon alfa-2a (PEG) and RBV (Arm 2 only) for 24-48 weeks to the original treatment regimen in subjects who experience viral breakthrough or relapse and enter the Rescue Therapy Substudy

    Measured: 24-48 weeks

Timeline

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

  1. First posted16 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJan 2013
  4. Study completionJul 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
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435226
Sponsor's protocol ID
GS-US-248-0131
Status last verified
Nov 2013
First submitted
13 Sep 2011
Last updated
17 Dec 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GS-5885, GS-9451 and tegobuvir in people with Hepatitis C, Chronic, run by Gilead Sciences at 51 sites in 2 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 10 inclusion and 5 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Germany. 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 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?

Safety and Tolerability (time frame: 24 weeks). 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 NCT01435226.

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 17 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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