Conditions: Hepatitis Hepatitis B, Chronic Cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 232
Healthy volunteers: no

Brief summary:
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

Detailed description:
Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were pre-stratified by screening Child-Turcotte-Pugh score (CTP score \< 9 or ≥ 9) and ALT level (within normal limits (WNL) or \> 1.0 x ULN) to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms. After 104 weeks of treatment, participants were followed-up with for an additional 16 weeks.

Arms:
arm 1: Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment. arm 2: Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.

Interventions: intervention 1: Telbivudine intervention 2: Lamivudine intervention 3: Placebo
Intervention descriptions: intervention 1: 600mg/day oral tablet for 104 weeks intervention 2: 100mg/day oral tablet for 104 weeks intervention 3: Telbivudine matching placebo or lamivudine matching placebo tablet.

Protocol document: