Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Entecavir; Telbivudine

Criteria

Inclusion Criteria:

• Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B

• Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

• Pregnant or breastfeeding

• Unwilling to use double barrier method of contraception

• Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)

• Received Hepatitis B therapy in the past

• Use of immunomodulatory therapy in past 12 months

• History of or symptoms of hepatic decompensation or pancreatitis

• Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs

• Concurrent medication likely to preclude compliance with schedule of evaluations

• Use of other investigational drugs within 30 days of enrollment

• Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply