GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01353248
First received: April 22, 2011
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: GS-5885 Drug: Tegobuvir Drug: GS-9451 Drug: ribavirin tablet |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Sustained virologic response (SVR) [ Time Frame: 24 weeks of off-treatment follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability [ Time Frame: through 24 weeks of off-treatment follow-up ] [ Designated as safety issue: Yes ]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.
- HCV RNA < Lower Limit Of Quantification [ Time Frame: Weeks 1, 2, 4, 12 and 24 ] [ Designated as safety issue: No ]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.
- Rescue Therapy Substudy SVR [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]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.
- Emergence of viral resistance [ Time Frame: 12 or 24 weeks ] [ Designated as safety issue: No ]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.
- Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV [ Time Frame: Through Week 2 of therapy ] [ Designated as safety issue: No ]HCV RNA levels, pharmacokinetics and viral sequencing
- Pharmacokinetics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV [ Time Frame: Through Week 2 of therapy ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
|
Drug: GS-5885
tablet, 30 mg QD
Drug: Tegobuvir
capsule, 30 mg BID
Drug: GS-9451
tablet, 200 mg QD
Drug: ribavirin tablet
(weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
|
|
Active Comparator: Arm 2
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
|
Drug: Tegobuvir
capsule, 30 mg BID
Drug: GS-9451
tablet, 200 mg QD
Drug: ribavirin tablet
(weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Drug: GS-5885
tablet, 90 mg QD
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353248
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham Gastroenterology Associates, P.C. | |
| Birmingham, Alabama, United States, 35209 | |
| Digestive Health Specialists of the Southeast | |
| Dothan, Alabama, United States, 36305 | |
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Southern California Liver Centers | |
| Coronado, California, United States, 92118 | |
| UCSF Fresno Medical Education Program (MEP) | |
| Fresno, California, United States, 93721 | |
| Stanford University School of Medicine | |
| Palo Alto, California, United States, 94304 | |
| University of California San Diego | |
| San Diego, California, United States, 92103 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92154 | |
| UCSF | |
| San Francisco, California, United States, 94143 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307 | |
| United States, Florida | |
| Bach and Godofsky Infectious Diseases | |
| Bradenton, Florida, United States, 34209 | |
| University of Florida - Gainesville | |
| Gainesville, Florida, United States, 32610 | |
| Borland-Groover Clinic | |
| Jacksonville, Florida, United States, 32256 | |
| University of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Orlando Clinical Research Center | |
| Orlando, Florida, United States, 32809 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| Gastrointestinal Specialists of Georgia PC | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Private Practice | |
| Opelousas, Louisiana, United States, 70570 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Lutherville, Maryland, United States, 21093 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, Mississippi | |
| Gastrointestinal Associates, PA | |
| Jackson, Mississippi, United States, 39202 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7584 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Options Health Research, LLC | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| University of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Gastro One | |
| Germantown, Tennessee, United States, 38138 | |
| Memphis Gastroenterology Group | |
| Germantown, Tennessee, United States, 38138 | |
| Columbia Medical Group, The Frist Clinic | |
| Nashville, Tennessee, United States, 37203 | |
| Nashville Gastrointestinal Specialists, Inc | |
| Nashville, Tennessee, United States, 37211 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Research Specialists of Texas | |
| Houston, Texas, United States, 77030 | |
| Alamo Medical Research | |
| San Antonio, Texas, United States, 78215 | |
| United States, Utah | |
| Lifetree Clinical Research, LC | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Virginia | |
| Inova Fairfax Hospital - Center for Liver Diseases | |
| Falls Church, Virginia, United States, 22042 | |
| Liver Institute of Virginia, Bon Secours Health System | |
| Newport News, Virginia, United States, 23602 | |
| Puerto Rico | |
| Fundacion de Investigacion de Diego | |
| San Juan, Puerto Rico, 00927 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Benedetta Massetto, MD, PhD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01353248 History of Changes |
| Other Study ID Numbers: | GS-US-248-0120 |
| Study First Received: | April 22, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
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 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013