An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

This study has been completed.

Sponsor:

Collaborator:

Novartis Pharmaceuticals

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00124241

First received: July 25, 2005

Last updated: May 8, 2015

Last verified: May 2015

History of Changes

Purpose

This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.

Condition	Intervention	Phase
Hepatitis B	Drug: telbivudine Drug: lamivudine	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Telbivudine Lamivudine

U.S. FDA Resources

Further study details as provided by Novartis:


Study Completion Date:	November 2005
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
Patient remains seropositive for hepatitis B surface antigen (HBsAg)

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Patient is pregnant or breast-feeding
Patient has signs of decompensated chronic hepatitis B

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124241

Locations


United States, California

Los Angeles, California, United States
Canada

Toronto, Canada
China

Hong Kong, China
France

Paris, France

Sponsors and Collaborators

Novartis

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00124241 History of Changes
Other Study ID Numbers:	NV-02B-010
Study First Received:	July 25, 2005
Last Updated:	May 8, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis B Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections	Hepadnaviridae Infections DNA Virus Infections Lamivudine Telbivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 28, 2016

To Top