A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Must be between 18 and 65 years of age

• Must have Screening plasma HBV DNA ≥ 2x10^3 IU/mL

• Must have chronic HBV infection for at least 6 months

• Must have estimated creatinine clearance (CLCr) ≥ 70 mL/min

• Not pregnant or nursing

• Women must be of non-childbearing potential OR of childbearing potential with confirmed negative pregnancy tests

• Consistent and correct use of recommended methods of birth control for men and women

Exclusion Criteria:

• Pregnant or lactating subjects

• Receipt of anti-HBV nucleoside/nucleotide therapy. Subjects who have failed prior Interferon treatment, greater than 6 months prior to screening, are permitted to participate in the study screening

• Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)

• Presence of autoimmune disorders

• History of liver disease other than Hepatitis B

• History of Gilbert's Disease

• Any sign of decompensated liver disease

• Known or suspected cirrhosis

• Evidence of hepatocellular carcinoma

• Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities

• Electrolyte abnormalities

• History of treatment that permanently alters the gastric condition

• Alcohol or substance abuse

• History of bleeding diathesis

• Significant bone disease