Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: ADV group; Drug: LAM group

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316719

ADF105220

Details and patient eligibility

About

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Enrollment: 105 patients

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have compensated chronic hepatitis B.
• Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
• Ability to read, understand, and sign the informed consent.
• Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria

• Having or suspected of having liver cancer.
• Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
• Autoimmune hepatitis.
• Received any previous transplantation or having a plan for any transplantation.
• Existence of any serious complication, except hepatitis B.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups

Adefovir Dipivoxil (ADV)

Experimental group

Treatment:

Drug: ADV group

Lamivudine (LAM)

Active Comparator group

Treatment:

Drug: LAM group