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 |
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
We found this trial at
12
sites
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
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Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Utah Research is a major component in the life of the U benefiting...
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University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Indiana University Medical Center Indiana University Health is Indiana
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Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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