Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Lamivudine; Drug: Lamivudine plus Polyethylene glyco-interferon alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00140725

NUC30938

Details and patient eligibility

About

This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
• Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.

Exclusion criteria

• Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)