Chronic Genotype 1a or 1b HCV InfectionPhase 2NCT01434498
GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
A Phase 2 study testing GS-5885 tablet, GS-9451 tablet and tegobuvir capsule in people with Chronic Genotype 1a or 1b HCV Infection, run by Gilead Sciences at 50 sites in 3 countries.
Trial summary
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Genotype 1a or 1b HCV Infection
- What is being tested?
- GS-5885 tablet, GS-9451 tablet and tegobuvir capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 50 sitesin 3 countries
- Study dates
- Sep 2011to Jan 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
- Adult subjects 18 and older with chronic HCV infection
- Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- Interferon ineligible or intolerant
- Body mass index (BMI) between 18 and 40 kg/m2
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Show all 9Show fewer
- Screening laboratory values within defined thresholds
- Has not been exposed to any investigational drug or device within 30 days of the Screening visit
- Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Who cannot join
- Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
- Decompensated liver disease or cirrhosis
- Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- History of difficulty with blood collection and/or poor venous access
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Suspicion of hepatocellular carcinoma
- Clinically-relevant drug abuse
Trial locations and contacts
50 sites in 3 countries.
50 sites in 3 countries
United States36 sites
The North Texas Research Institute
Arlington, Texas, 76012
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801
University of Colorado
Aurora, Colorado, 80045
California Liver Institute
Beverly Hills, California, 90211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deconess 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
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, 22042
The University of Texas Medical Branch
Galveston, Texas, 77555
Gastro One
Germantown, Tennessee, 38138
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
University of Kansas Medical Center
Kansas City, Kansas, 66160
Scripps Clinic
La Jolla, California, 92037
University of California, San Diego
La Jolla, California, 92161
Kaiser Permanente Medical Center
Los Angeles, California, 90027
Lightsource Medical
Los Angeles, California, 90036
Johns Hopkins University
Lutherville, Maryland, 21093
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
University of Miami, Center for Liver Diseases
Miami, Florida, 33136
Weill Cornell Medical College
New York, New York, 10021
Saint Michael's Medical Center
Newark, New Jersey, 07102
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
Orlando Immunology Center (ACH)
Orlando, Florida, 32803-1851
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University Gastroenterology
Providence, Rhode Island, 02905
Alamo Medical Research
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
Virginia Mason Medical Center
Seattle, Washington, 98101
The Research Institute
Springfield, Massachusetts, 01105
Canada13 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University Of Alberta Hospital
Edmonton, Alberta, T6G 2C8
University of Alberta
Edmonton, Alberta, T6G 2X8
London Health Sciences Centre
London, Ontario, N6A 5A5
Hospital Saint-Luc DU CHUM
Montreal, Quebec, H2X3J4
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2N2
Toronto Western Hospital
Toronto, Ontario, M5T2S8
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
University of British Columbia
Vancouver, British Columbia, V6Z 2C9
GIRI GI Research Institute
Vancouver, British Columbia, V6Z 2K5
University of Manitoba
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.
- Conditions
- Chronic Genotype 1a or 1b HCV Infection
- Being tested
- GS-5885 tablet, GS-9451 tablet, tegobuvir capsule, ribavirin tablet, placebo matching ribavirin tablet
- Keywords
- Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Treatment naïve, HCV RNA, Polymerase inhibitor, Protease inhibitor, Interferon intolerant, Interferon ineligible, GS-9190, GS-9451, GS-5885
- 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-5885 tabletDrug
GS-5885 tablet, 90 mg, QD
GS-9451 tabletDrug
GS-9451 tablet, 200 mg QD
tegobuvir capsuleDrug
tegobuvir capsule, 30 mg BID
ribavirin tabletDrug
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
placebo matching ribavirin tabletDrug
placebo matching ribavirin tablet, BID
placebo matching tegobuvir capsuleDevice
placebo matching tegobuvir capsule, BID
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks Receives: Drug: GS-5885 tablet; Drug: GS-9451 tablet; Drug: tegobuvir capsule; Drug: ribavirin tablet |
| Arm 2 | Active comparator | GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks Receives: Drug: GS-5885 tablet; Drug: GS-9451 tablet; Drug: tegobuvir capsule; Drug: placebo matching ribavirin tablet |
| Arm 3 | Active comparator | GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks Receives: Drug: GS-5885 tablet; Drug: GS-9451 tablet; Drug: ribavirin tablet; Device: placebo matching tegobuvir capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Through 24 weeks of off-treatment follow-up
Antiviral Activity
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) 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.
Measured: Through 24 weeks of off-treatment follow-up
Secondary outcomes (2)
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: Through 10 days of therapy
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Genotype 1a or 1b HCV InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McNally, PhD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434498
- Sponsor's protocol ID
- GS-US-248-0132
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2011
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)
- ClinicalTrials.gov ID
- NCT01434498
- Acronym / sponsor ID
- GS-US-248-0132
- Conditions
- Chronic Genotype 1a or 1b HCV Infection
- Keywords
- Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Treatment naïve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: GS-5885 tablet, Drug: GS-9451 tablet, Drug: tegobuvir capsule, Drug: ribavirin tabletGS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks |
| Arm 2 | Active comparator | Drug: GS-5885 tablet, Drug: GS-9451 tablet, Drug: tegobuvir capsule, Drug: placebo matching ribavirin tabletGS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks |
| Arm 3 | Active comparator | Drug: GS-5885 tablet, Drug: GS-9451 tablet, Drug: ribavirin tablet, Device: placebo matching tegobuvir capsuleGS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult subjects 18 and older with chronic HCV infection
- Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- Interferon ineligible or intolerant
- Body mass index (BMI) between 18 and 40 kg/m2
Key exclusion criteria (8 listed)
- Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
- Decompensated liver disease or cirrhosis
- Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- History of difficulty with blood collection and/or poor venous access
- Pregnant or nursing female or male with pregnant female partner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-5885 tabletGS-5885 tablet, 90 mg, QD | Drug | Arm 1, Arm 2, Arm 3 |
| GS-9451 tabletGS-9451 tablet, 200 mg QD | Drug | Arm 1, Arm 2, Arm 3 |
| tegobuvir capsuletegobuvir capsule, 30 mg BID | Drug | Arm 1, Arm 2 |
| ribavirin tabletribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) | Drug | Arm 1, Arm 3 |
| placebo matching ribavirin tabletplacebo matching ribavirin tablet, BID | Drug | Arm 2 |
| placebo matching tegobuvir capsuleplacebo matching tegobuvir capsule, BID | Device | Arm 3 |
Primary outcome
Safety and Tolerability
Time frame: Through 24 weeks of off-treatment follow-up
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.
Antiviral Activity
Time frame: Through 24 weeks of off-treatment follow-up
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) 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.
2 secondary outcomes
Viral Dynamics
Time frame: Through 10 days of therapy
Composite (or Profile) of Pharmacokinetics
Time frame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John McNally, PhD study director
Gilead Sciences
50 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-5885 tablet, GS-9451 tablet and tegobuvir capsule in people with Chronic Genotype 1a or 1b HCV Infection, run by Gilead Sciences at 50 sites in 3 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 8 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 20 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 50 sites in United States, Canada, Puerto Rico. 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: Through 24 weeks of off-treatment follow-up). 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?
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 20 Dec 2013.