A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
1 other identifier
interventional
51
5 countries
20
Brief Summary
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2012
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 20, 2013
December 1, 2013
1.6 years
April 30, 2012
December 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of adverse events in single and multiple oral doses of GS-9620
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital signs measurements
Periodically Day 1 to 6 months
Secondary Outcomes (3)
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Day 1 and Day 8
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Days 1, 2, 3, 5, 8
Reduction of hepatitis B (HBV) viral load from baseline
Screening, Baseline, Day 8 or 15
Study Arms (8)
0.3mg GS-9620
EXPERIMENTAL1mg GS-9620
EXPERIMENTAL2mg GS-9620
EXPERIMENTAL4mg GS-9620
EXPERIMENTAL0.3mg GS-9620 QW x 2 doses
EXPERIMENTAL1mg GS-9620 QW x 2 doses
EXPERIMENTAL2mg GS-9620 QW x 2 doses
EXPERIMENTAL4mg GS-9620 QW x 2 doses
EXPERIMENTALInterventions
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.
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
You may qualify if:
- Chronic HBV infection for ≥ 6 months
- Currently on treatment with at least 1 HBV approved oral drug (i.e. lamivudine, telbivudine, entecavir, adefovir, tenofovir) ≥ 3 months prior to screening
- HBsAg ≥ 250 IU/mL
- HBV DNA at below the level of quantitation (BLQ; to be confirmed at screening)
- Absence of extensive bridging fibrosis (Metavir 3 or greater)or cirrhosis
- Creatinine clearance ≥ 70 mL/min
You may not qualify if:
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (20)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202-5121, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 022154, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Nepean Hospital, Department of ID
Kingswood, New South Wales, 2747, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Monash University, Dept. of Medicine
Clayton, Victoria, 3168, Australia
Alfred Hospital, Department of Gastroenterology
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital
Nedlands, Western Australia, 6009, Australia
University of Calgary, Heritage Medical Research Center
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Algorithme Pharma, Inc.
Laval, Quebec, H7V 4B3, Canada
Aukland Clinical Studies
Grafton, Aukland, 1142, New Zealand
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Benedetta Massetto, M.D.
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 3, 2012
Study Start
April 1, 2012
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
December 20, 2013
Record last verified: 2013-12