Clinical trial NCT00076336: Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Official title: Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis
Hepatitis B, Chronic
Cirrhosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-01-22
Enrollment: 232
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: From Baseline to Week 52
Secondary outcomes:
measure: Time to Initial Clinical Response
timeFrame: From Baseline to Week 104
measure: Duration of Initial Clinical Response
timeFrame: Baseline to Week 104
measure: Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
timeFrame: From Baseline to weeks 52 and 104
measure: Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
timeFrame: Baseline and Week 104
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Indianapolis
country: United States
state: Indiana
city: Rochester
country: United States
state: Minnesota
city: New York
country: United States
state: New York
city: Houston
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
city: Heidelburg
country: Australia
city: Winnipeg
country: Canada
city: Hong Kong
country: China
city: Villejuif Cedex
country: France
city: Hannover
country: Germany
city: New Delhi
country: India
facility: Novartis
city: Tel Aviv
country: Israel
city: Seoul
country: Korea, Republic of
city: Riga
country: Latvia
facility: Novartis
city: Kuala Lumpur
country: Malaysia
facility: Novartis
city: Auckland
country: New Zealand
city: Krakow
country: Poland
facility: Novartis
city: Moscow
country: Russian Federation
facility: Novartis
city: Singapore
country: Singapore
city: Barcelona
country: Spain
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Istanbul
country: Turkey
facility: Novartis
city: London
country: United Kingdom
city: Hanoi
country: Vietnam
facility: Novartis
Study officials:
References:
citation: E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010