Hepatitis C, ChronicPhase 2NCT01353248
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
A Phase 2 study testing GS-5885, Tegobuvir and GS-9451 in people with Hepatitis C, Chronic, run by Gilead Sciences at 43 sites in 2 countries.
Trial summary
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection. 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?
- GS-5885, Tegobuvir and GS-9451
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 43 sitesin 2 countries
- Study dates
- May 2011to Mar 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
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- 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
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
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- 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 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
43 sites in 2 countries.
43 sites in 2 countries
United States42 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Advanced Clinical Research Institute
Anaheim, California, 92801
Birmingham Gastroenterology Associates, P.C.
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Bach and Godofsky Infectious Diseases
Bradenton, Florida, 34209
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7584
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Southern California Liver Centers
Coronado, California, 92118
Baylor University Medical Center
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48202
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital - Center for Liver Diseases
Falls Church, Virginia, 22042
UCSF Fresno Medical Education Program (MEP)
Fresno, California, 93721
University of Florida - Gainesville
Gainesville, Florida, 32610
Gastro One
Germantown, Tennessee, 38138
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
Research Specialists of Texas
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202
Borland-Groover Clinic
Jacksonville, Florida, 32256
Johns Hopkins University
Lutherville, Maryland, 21093
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060
University of Miami School of Medicine
Miami, Florida, 33136
Columbia Medical Group, The Frist Clinic
Nashville, Tennessee, 37203
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211
Mount Sinai Medical Center
New York, New York, 10029
Liver Institute of Virginia, Bon Secours Health System
Newport News, Virginia, 23602
Private Practice
Opelousas, Louisiana, 70570
Orlando Immunology Center
Orlando, Florida, 32803
Orlando Clinical Research Center
Orlando, Florida, 32809
Stanford University School of Medicine
Palo Alto, California, 94304
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Lifetree Clinical Research, LC
Salt Lake City, Utah, 84106
Alamo Medical Research
San Antonio, Texas, 78215
University of California San Diego
San Diego, California, 92103
Kaiser Permanente
San Diego, California, 92154
UCSF
San Francisco, California, 94143
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
- Conditions
- Hepatitis C, Chronic
- Being tested
- GS-5885, Tegobuvir, GS-9451, ribavirin tablet
- Keywords
- Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, HCV RNA, Polymerase inhibitor, Protease inhibitor, Treatment naïve, GS-5885, GS-9451, Tegobuvir
- 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
tablet, 30 mg QD
TegobuvirDrug
capsule, 30 mg BID
GS-9451Drug
tablet, 200 mg QD
ribavirin tabletDrug
(weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-5885Drug
tablet, 90 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks. Receives: Drug: GS-5885; Drug: Tegobuvir; Drug: GS-9451; Drug: ribavirin tablet |
| Arm 2 | Active comparator | GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. Receives: Drug: Tegobuvir; Drug: GS-9451; Drug: ribavirin tablet; Drug: GS-5885 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR)
Measured: 24 weeks of off-treatment follow-up
Secondary outcomes (6)
Safety and tolerability
To evaluate the safety and tolerability of 30 mg or 90 mg GS-5885 when given with GS-9451, Tegobuvir and RBV for 12 or 24 weeks. Safety endpoints will be analyzed by the number and percent of subjects with events or abnormalities for categorical values or 8-number summary (n, mean, standard deviation, median, Q1, Q3, minimum, maximum) for continuous data by treatment group.
Measured: through 24 weeks of off-treatment follow-up
HCV RNA < Lower Limit Of Quantification
To evaluate the antiviral efficacy at Weeks 1, 2, 4, 12 and 24, as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse.
Measured: Weeks 1, 2, 4, 12 and 24
Rescue Therapy Substudy SVR
To evaluate the antiviral efficacy (as defined by SVR) of the addition of pegylated interferon (PEG) for 24 weeks to GS-5885, GS-9451, tegobuvir and RBV in subjects who experience viral breakthrough on treatment.
Measured: 24 Weeks
Emergence of viral resistance
To evaluate the emergence of viral resistance during treatment with GS-9451, Tegobuvir and RBV when given with 30 mg or 90 mg GS-5885 for 12 or 24 weeks.
Measured: 12 or 24 weeks
Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
HCV RNA levels, pharmacokinetics and viral sequencing
Measured: Through Week 2 of therapy
Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
Pharmacokinetics (Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½) will be listed
and summarized for GS-5885, GS-9451 and Tegobuvir using descriptive statistics (e.g.,
sample size, arithmetic mean, geometric mean, % coefficient of variation, standard deviation,
median, minimum, and maximum). Plasma concentrations of the study drug over time will be
summarized using descriptive statistics
Measured: Through Week 2 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benedetta Massetto, MD, PhD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353248
- Sponsor's protocol ID
- GS-US-248-0120
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2011
- Last updated
- 20 Dec 2013
- Results posted
- No
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, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
- ClinicalTrials.gov ID
- NCT01353248
- Acronym / sponsor ID
- GS-US-248-0120
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, HCV RNA, Polymerase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 May 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.
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: GS-5885, Drug: Tegobuvir, Drug: GS-9451, Drug: ribavirin tabletGS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks. |
| Arm 2 | Active comparator | Drug: Tegobuvir, Drug: GS-9451, Drug: ribavirin tablet, Drug: GS-5885GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- Autoimmune disease
- Decompensated liver disease or cirrhosis
- Poorly controlled diabetes mellitus
- Severe psychiatric illness
- Severe chronic obstructive pulmonary disease (COPD)
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-5885tablet, 30 mg QD | Drug | Arm 1 |
| Tegobuvircapsule, 30 mg BID | Drug | Arm 1, Arm 2 |
| GS-9451tablet, 200 mg QD | Drug | Arm 1, Arm 2 |
| ribavirin tablet(weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID) | Drug | Arm 1, Arm 2 |
| GS-5885tablet, 90 mg QD | Drug | Arm 2 |
Primary outcome
Sustained virologic response (SVR)
Time frame: 24 weeks of off-treatment follow-up
6 secondary outcomes
Safety and tolerability
Time frame: through 24 weeks of off-treatment follow-up
HCV RNA < Lower Limit Of Quantification
Time frame: Weeks 1, 2, 4, 12 and 24
Rescue Therapy Substudy SVR
Time frame: 24 Weeks
Emergence of viral resistance
Time frame: 12 or 24 weeks
Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
Time frame: Through Week 2 of therapy
Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
Time frame: Through Week 2 of therapy
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.
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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.
Benedetta Massetto, MD, PhD study director
Gilead Sciences
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-5885, Tegobuvir and GS-9451 in people with Hepatitis C, Chronic, run by Gilead Sciences at 43 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 9 inclusion and 12 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 43 sites in United States, 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?
Sustained virologic response (SVR) (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?
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.