Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus Infection
NCT ID: NCT01072695
Last Updated: 2012-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2010-02-28
2012-01-31
Brief Summary
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Following randomization, subjects will return for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 28 day treatment phase. During the treatment phase, subjects will receive oral study drugs twice daily for 28 days and PEG once weekly for Part B. Subjects then receive PEG/RIBA as local SOC starting on Day 28 (not provided as part of the study). Following completion of the 28-day treatment phase, subjects will be followed for approximately 72 weeks.
Detailed Description
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In Part A, for any subjects meeting pre-defined, individual, virologic criteria, PEG/RIBA standard of care will be started prior to Day 28.
Both PEG and RIBA will be administered at their currently approved dosages for treatment of HCV infection in accordance with appropriate labeling. Subjects will be monitored for safety (including ECG monitoring), antiviral activity, pharmacokinetics, and resistance 2-3 times weekly through Day 28.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
GS-9256
75 mg BID x 28 days
GS-9190
40 mg BID x 28 days
Arm 2
GS-9256
75 mg BID x 28 days
GS-9190
40 mg BID x 28 days
Ribavirin
1000-1200 mg/day given BID
Arm 3
GS-9256
75 mg BID x 28 days
GS-9190
40 mg BID x 28 days
Ribavirin
1000-1200 mg/day given BID
Peginterferon alfa-2a
180 ug q week
Interventions
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GS-9256
75 mg BID x 28 days
GS-9190
40 mg BID x 28 days
Ribavirin
1000-1200 mg/day given BID
Peginterferon alfa-2a
180 ug q week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing able to provide informed consent
* BMI between 18 and 36 kg/m2 (inclusive)
* Chronic HCV infection, genotype 1
* HCV RNA \>/= 3 log, but \< 7.2 log10 IU/ml at screen
* Liver biopsy, FibroTest, or FibroScan indicating absence of cirrhosis
* HCV treatment naïve with imminent plans to start treatment with PEG/RIBA
* QTcF \</= 450 msec at screen
* ALT, AST, GGT \< 5 X ULN at the screening visit
* Creatinine clearance \>= 50 mL/min
* Absolute neutrophil count \>= 1500/mm3
* Hemoglobin \>/= 12 g/dL (female), \>/= 13 g/dL (male)
* Males agree to use of effective contraception and refrain from sperm donation
* Able to comply with dosing instructions and study visits
* Of generally good health
Exclusion Criteria
* Infection with other HCV genotype or multiple HCV genotypes
* Poorly controlled diabetes
* Hemoglobinopathy or known retinal disease
* History of sarcoidosis or invasive malignancy
* Untreated or significant psychiatric illness
* Co-infection with hepatitis B virus or human immunodeficiency virus
* Chronic use of systemic immunosuppressive agents
* Autoimmune disorders
* Severe COPD
* History of significant cardiac disease
* Known cirrhosis
* Non-HCV chronic liver disease
* Transplantation
* Suspicion of hepatocellular carcinoma
* Bilirubin above the normal range or Gilbert's syndrome
* Decompensated liver disease
* Clinically significant illness
* GI disease that could interfere with absorption
* Acute porphyria
* Current excessive alcohol ingestion, averaging \> 3 drinks/day for females and \> 4 drinks/day for males or current binge drinking
* Positive urine drug screen
* History of difficult blood collection
* Significant recent blood loss
* Prohibited medications, including H2 antagonists, investigational agents
* Restricted fruits, fruit juices
* Hypersensitivity
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Juan Betular
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Brussels, , Belgium
Brussels, , Belgium
Clichy, , France
La Tronche, , France
Paris, , France
Düsseldorf, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Würzburg, , Germany
London, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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GS-US-196-0112
Identifier Type: -
Identifier Source: org_study_id