Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection
NCT ID: NCT00874796
Last Updated: 2014-02-04
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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TERMINATED
PHASE2
307 participants
INTERVENTIONAL
2009-05-31
2010-07-31
Brief Summary
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Following randomization, subjects will return within seven business days for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 26 week treatment phase. During the treatment phase, subjects will receive study drug once daily for 24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug once every other day for one week and then every 3 days for one week. Following completion of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GS-9450 10 mg/day
GS-9450 taken as one 10 mg capsule by mouth once daily
GS-9450
Taken as one capsule by mouth once daily
GS-9450 40 mg/day
GS-9450 taken as one 40 mg capsule by mouth once daily
GS-9450
Taken as one capsule by mouth once daily
Placebo
Placebo taken as one placebo capsule by mouth once daily
Placebo
Taken as one placebo capsule (matching in appearance to GS-9450 capsules) by mouth once daily
Interventions
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GS-9450
Taken as one capsule by mouth once daily
Placebo
Taken as one placebo capsule (matching in appearance to GS-9450 capsules) by mouth once daily
Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection, defined as having documented HCV infection (antibody or RNA positivity) at least 6 months prior to Baseline (Day 1) with HCV viremia at screening
* Screening Knodell necroinflammatory score \>= 3 based on liver biopsy evaluation (as determined by local pathologist) conducted anytime during the 45-day screening period
* ALT \> the upper limit of the normal range (ULN) but \< 10 X ULN at the screening visit
* Previously failed pegylated interferon-based HCV therapy in combination with ribavirin therapy, or is unable to tolerate or has contraindications to receiving interferon or ribavirin therapy
* BMI between 19 and 36 kg/m2 (inclusive)
* Creatinine clearance \>= 70 mL/min
* absolute neutrophil count \>= 1000/mm3
* Hemoglobin \> 10 g/dL
* Have no clinical or laboratory evidence of hepatic decompensation
Exclusion Criteria
* Child-Pugh grade B or C cirrhosis
* Evidence of hepatocellular carcinoma
* Positive urine drug screen for cocaine or amphetamines
* Infection with HCV genotype 3
* Co-infection with hepatitis B virus or human immunodeficiency virus
* Pancreatitis
* Recent significant infection or symptoms of infection
* Autoimmune disorders
* Any history of seizure
* Is a public transportation operator (pilot of airplane or ship; air traffic controller; bus, train or subway driver) or operates heavy construction machinery
* Transplantation
* History of malignancy
* Current excessive alcohol ingestion, averaging \> 3 drinks/day for females and \> 4 drinks/day for males
* History of or current binge drinking
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Ken Hirsch, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Beverly Hills, California, United States
Cypress, California, United States
La Jolla, California, United States
Mission Hills, California, United States
Palm Springs, California, United States
Pasadena, California, United States
San Clemente, California, United States
San Diego, California, United States
Washington D.C., District of Columbia, United States
Hialeah, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Novi, Michigan, United States
Saint Louis, Michigan, United States
Plymouth, Minnesota, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Hillsborough, New Jersey, United States
Morristown, New Jersey, United States
Santa Fe, New Mexico, United States
Johnson City, New York, United States
New York, New York, United States
Plainview, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Essen, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Mainz, , Germany
Bialystok, , Poland
Bydgoszcz, , Poland
Chorzów, , Poland
Kielce, , Poland
Wroclaw, , Poland
San Juan, , Puerto Rico
Santurce, , Puerto Rico
Brighton, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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GS-US-227-0106
Identifier Type: -
Identifier Source: org_study_id
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