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

sites

National Institute of Allergy and Infectious Diseases

Bethesda, Maryland 20892

from

Bethesda, MD