Trials / Completed
CompletedNCT00076336
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 16 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telbivudine | 600mg/day oral tablet for 104 weeks |
| DRUG | Lamivudine | 100mg/day oral tablet for 104 weeks |
| DRUG | Placebo | Telbivudine matching placebo or lamivudine matching placebo tablet. |
Timeline
- Start date
- 2003-12-01
- Primary completion
- 2009-12-01
- First posted
- 2004-01-22
- Last updated
- 2011-09-05
- Results posted
- 2011-09-05
Locations
28 sites across 21 countries: United States, Australia, Canada, China, France, Germany, India, Israel, Latvia, Malaysia, New Zealand, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam
Source: ClinicalTrials.gov record NCT00076336. Inclusion in this directory is not an endorsement.