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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis B

In brief

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

Key facts

Study ID

NCT01590654

Run by

Gilead Sciences

People needed

51

Starts

2012-04-01

Expected to finish

2013-12-01

Last updated by the study team

2013-12-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, 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
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Nepean Hospital, Department of ID — Kingswood, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Monash University, Dept. of Medicine — Clayton, Victoria, Australia
• Alfred Hospital, Department of Gastroenterology — Melbourne, 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. — Laval, Quebec, Canada
• Aukland Clinical Studies — Grafton, Aukland, New Zealand
• Asan Medical Center — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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