Status:
COMPLETED
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatitis
Hepatitis B, Chronic
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
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 Asia...
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 decompens...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00076336
Start Date
December 1 2003
Last Update
September 5 2011
Active Locations (28)
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1
Phoenix, Arizona, United States
2
Los Angeles, California, United States
3
Denver, Colorado, United States
4
Indianapolis, Indiana, United States