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

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

MedlinePlus related topics:

Cirrhosis Hepatitis Hepatitis B

Drug Information available for:

Lamivudine Hepatitis B Vaccines Telbivudine

U.S. FDA Resources

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

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

Show 28 Study Locations

Sponsors and Collaborators

Novartis

More Information

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

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Chronic

Fibrosis

Hepatitis B, Chronic

Hepatitis B

Lamivudine

Hepatitis, Viral, Human

DNA Virus Infections

Liver Cirrhosis

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-HIV Agents

Pathologic Processes

Anti-Retroviral Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Hepadnaviridae Infections

Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors

Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on November 19, 2008

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