A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:11/30/2013
Start Date:April 2012
End Date:October 2013
Contact:Benedetta Massetto, MD
Email:Benedetta.Massetto@gilead.com
Phone:650-522-5075

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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


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


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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330 Brookline Ave
Boston, Massachusetts 02215
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
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Kansas City, Missouri 64131
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Phoenix, Arizona
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