A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
NCT ID: NCT01591668
Last Updated: 2013-08-13
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
PHASE1
51 participants
INTERVENTIONAL
2012-03-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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0.3mg GS-9620
Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
1mg GS-9620
Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
2mg GS-9620
Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
4mg GS-9620
Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
0.3mg GS-9620 QW x 2 doses
Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
1mg GS-9620 QW x 2 doses
Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
2mg GS-9620 QW x 2 doses
Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
4mg GS-9620 QW x 2 doses
Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Interventions
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Single Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Multiple Ascending Dose Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection for at least 6 months, treatment naive
* HCV Viral load \> 100,000 IU/mL at Screening
* Monoinfection with HCV 1 genotype
* Hepatitis B surface antigen negative
* Screening ECG without clinically significant abnormalities
* BMI 18-33 kg/m\^2
* Creatinine clearing \> 70 mL/min
* Negative pregnancy test at screening
Exclusion Criteria
* Co-infection with hepatitis B virus (HBV) or HIV
* History of Gilberts disease
* Particular abnormal laboratory parameters
* Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
* Evidence of hepatocellular carcinoma
* On-going alcohol abuse
* Positive uring drug screen
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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Woodland International Research Group
Little Rock, Arkansas, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
CliniLabs
New York, New York, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Alamo Medical Research
San Antonio, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Fundacion De Investigacion De Diego
Santurce, PR, Puerto Rico
Countries
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References
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Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8.
Other Identifiers
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GS-US-243-0102
Identifier Type: -
Identifier Source: org_study_id