Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
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.
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.
Inclusion Criteria:

 -  Documented decompensated chronic hepatitis B defined by all of the following: 1.
 Clinical history compatible with decompensated chronic hepatitis B related cirrhosis;
 2. Child-Turcotte-Pugh score > 7 points.

 -  Evidence of hepatic cirrhosis or portal hypertension.

 Other protocol-defined inclusion criteria may apply.

 Exclusion Criteria:

 -  Patient is pregnant or breastfeeding.

 -  Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human
 immunodeficiency virus (HIV).

 -  Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis
 B virus (HBV) nucleoside or nucleotide analog at any time

 -  Patient has received interferon or other immunomodulatory treatment for HBV infection
 in the 12 months before Screening for this study.

 Other protocol-defined exclusion criteria may apply.