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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B; Hepatitis B

Treatments: Drug: Entecavir; Drug: Telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412529

CLDT600A2407

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Telbivudine

Experimental group

Treatment:

Drug: Telbivudine

Entecavir

Active Comparator group

Treatment:

Drug: Entecavir