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

NCT00076336 | Completed Phase 3 Results

• 1 other identifier: CLDT600A2301
• Study Type: interventional
• Target: 232
• Locations: 21 countries
• Sites: 28

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.

Conditions

Hepatitis; Hepatitis B, Chronic; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Response

  Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA \< 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.

  From Baseline to Week 52

Secondary Outcomes (4)

• Time to Initial Clinical Response

  From Baseline to Week 104

• Duration of Initial Clinical Response

  Baseline to Week 104

• Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104

  From Baseline to weeks 52 and 104

• Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score

  Baseline and Week 104

Study Arms (2)

Telbivudine 600 mg

EXPERIMENTAL

Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.

Drug: Telbivudine; Drug: Placebo

Lamivudine 100 mg

ACTIVE COMPARATOR

Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.

Drug: Lamivudine; Drug: Placebo

Interventions

Telbivudine DRUG

600mg/day oral tablet for 104 weeks

Also known as: LDT600

Telbivudine 600 mg

Lamivudine DRUG

100mg/day oral tablet for 104 weeks

Lamivudine 100 mg

Placebo DRUG

Telbivudine matching placebo or lamivudine matching placebo tablet.

Lamivudine 100 mg; Telbivudine 600 mg

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Heidelburg, Australia

Location

Unknown Facility

Winnipeg, Canada

Location

Unknown Facility

Hong Kong, China

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Hanover, Germany

Location

Novartis

New Delhi, India

Location

Unknown Facility

Tel Aviv, Israel

Location

Novartis

Riga, Latvia

Location

Novartis

Kuala Lumpur, Malaysia

Location

Unknown Facility

Auckland, New Zealand

Location

Novartis

Krakow, Poland

Location

Novartis

Moscow, Russia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

Novartis

Istanbul, Istanbul, Turkey (Türkiye)

Location

Unknown Facility

London, United Kingdom

Location

Novartis

Hanoi, Vietnam

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Hepatitis; Hepatitis B, Chronic; Fibrosis

Interventions

Telbivudine; Lamivudine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Dideoxynucleosides

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2004
• First Posted: January 22, 2004
• Study Start: December 1, 2003
• Primary Completion: December 1, 2009
• Last Updated: September 5, 2011
• Results First Posted: September 5, 2011

Record last verified: 2011-08

Locations

RU (1); PL (1); TU (1); GB (1); TW (1); DE (1); LA (1); TH (1); US (8); SG (1); VN (1); MY (1); IN (1); NZ (1); KR (1); CA (1); IL (1); AU (1); ES (1); CN (1); FR (1)