A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
NCT ID: NCT01590641
Last Updated: 2013-11-14
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
49 participants
INTERVENTIONAL
2012-04-30
2013-10-31
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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4mg GS-9620
Single Ascending Dose (SAD) 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 Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
0.3mg GS-9620 QW x 2 doses
Multiple Ascending Dose (MAD) Cohorts
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 (MAD) Cohorts
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 (MAD) Cohorts
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 (MAD) Cohorts
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)
0.3mg GS-9620
Single Ascending Dose (SAD) 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 Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
1mg GS-9620
Single Ascending Dose (SAD) 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 Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
2mg GS-9620
Single Ascending Dose (SAD) 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 Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Interventions
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Single Ascending Dose (SAD) 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 Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Multiple Ascending Dose (MAD) Cohorts
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
* HBsAg ≥ 250 IU/mL
* HBV treatment naïve
* Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis
* Creatinine clearance ≥ 70 mL/min
Exclusion Criteria
* History of Gilberts disease
* Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of hepatic decompensation
* Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease(COPD), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
* Evidence of hepatocellular carcinoma
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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Benedetta Massetto, M.D.
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
West Coast Clinical Trials, LLC
Costa Mesa, California, United States
University of California Antiviral Research Center (AVRC)
San Diego, California, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Nepean Hospital
Kingswood, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Monash University, Department of Medicine
Clayton, Victoria, Australia
Royal Perth Hospital
Nedlands, Western Australia, Australia
University of Calgary, Heritage Medical Research Center
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Algorithme Pharma, Inc.
Montreal, Quebec, Canada
Auckland Clinical Studies
Grafton, Auckland, New Zealand
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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GS-US-283-0106
Identifier Type: -
Identifier Source: org_study_id