Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00076336

Purpose

This research study is being 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.

Condition	Intervention	Phase
Hepatitis Hepatitis B, Chronic Cirrhosis	Drug: telbivudine Drug: lamivudine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis B

Drug Information available for: Lamivudine Telbivudine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Primary Outcome is a composite endpoint termed Clinical Response, defined as achievement of the following three efficacy criteria: Serum HBV DNA < 4 log10 copies/mL, Normal ALT level, Improvement or stabilization in CTP score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to Clinical Response; Duration of Clinical Response; Improvement, Stabilization, and Worsening in CTP score; Improvement, Stabilization, and Worsening in a modified (3-component) CTP score [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Enrollment:	232
Study Start Date:	December 2003
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: telbivudine 600mg/day oral tablet for 2 years
2: Active Comparator	Drug: lamivudine 100mg/day oral tablet for 2 years

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 HIV.
Patient previously received lamivudine, adefovir, or an investigational anti-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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076336

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Locations

United States, Arizona

Phoenix, Arizona, United States
United States, California

Los Angeles, California, United States
United States, Colorado

Denver, Colorado, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Minnesota

Rochester, Minnesota, United States
United States, New York

New York, New York, United States
United States, Texas

Houston, Texas, United States
United States, Wisconsin

Madison, Wisconsin, United States
Australia

Heidelburg, Australia
Canada

Winnipeg, Canada
China

Hong Kong, China
France

Villejuif Cedex, France
Germany

Hannover, Germany
India
Novartis
New Delhi, India
Israel

Tel Aviv, Israel
Korea, Republic of

Seoul, Korea, Republic of
Latvia
Novartis
Riga, Latvia
Malaysia
Novartis
Kuala Lumpur, Malaysia
New Zealand

Auckland, New Zealand
Poland
Novartis
Krakow, Poland
Russian Federation
Novartis
Moscow, Russian Federation
Singapore

Singapore, Singapore
Spain

Barcelona, Spain
Taiwan

Taipei, Taiwan
Thailand

Bangkok, Thailand
Turkey
Novartis
Istanbul, Turkey
United Kingdom

London, United Kingdom
Vietnam
Novartis
Hanoi, Vietnam

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	( Novartis )
Study ID Numbers:	CLDT600A2301
Study First Received:	January 20, 2004
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00076336 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Hepatitis, Chronic
Fibrosis
Lamivudine
Hepatitis, Viral, Human
Enzyme Inhibitors
Liver Cirrhosis
Antiviral Agents
Hepadnaviridae Infections

Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Pathologic Processes
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009