Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis, Hepatitis B, Chronic, Cirrhosis

In brief

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.

Key facts

Study ID

NCT00076336

Run by

Novartis Pharmaceuticals

People needed

232

Starts

2003-12-01

Last updated by the study team

2011-09-05

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Rochester, Minnesota, United States
• Study site — New York, New York, United States
• Study site — Houston, Texas, United States
• Study site — Madison, Wisconsin, United States
• Study site — Heidelburg, Australia
• Study site — Winnipeg, Canada
• Study site — Hong Kong, China
• Study site — Villejuif, France
• Study site — Hanover, Germany
• Novartis — New Delhi, India
• Study site — Tel Aviv, Israel
• Novartis — Riga, Latvia
• Novartis — Kuala Lumpur, Malaysia
• Study site — Auckland, New Zealand
• Novartis — Krakow, Poland
• Novartis — Moscow, Russia
• Study site — Singapore, Singapore
• Study site — Seoul, South Korea
• Study site — Barcelona, Spain
• Study site — Taipei, Taiwan
• Study site — Bangkok, Thailand

Full record on ClinicalTrials.gov

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