Phase 3
Completed N=232
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Source: ClinicalTrials.gov NCT00076336 ↗Enrolled (actual)
232
Serious AEs
55.0%
Results posted
Sep 2011
Primary outcomePrimary: Number of Participants With Clinical Response — 65; 62; 85; 82 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response |
65; 62; 85; 82; 78; 81 | — |
| SECONDARY Time to Initial Clinical Response |
137.5; 125.2 | — |
| SECONDARY Duration of Initial Clinical Response |
473.1; 456.3 | — |
| SECONDARY Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104 |
36; 44; 60; 52; 18; 18 | — |
| SECONDARY Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score |
30; 31; 57; 54; 27; 29 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00076336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.