Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies - Full Text View

Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00142298

Purpose

This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: telbivudine	Phase III

MedlinePlus related topics:

Hepatitis Hepatitis B

ChemIDplus related topics:

Hepatitis B Vaccines Telbivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies

Further study details as provided by Novartis:

Estimated Enrollment:

2000

Eligibility

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

Criteria

Inclusion Criteria:

Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine
Patient was not discontinued from previous Idenix-Sponsored study

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis C, hepatitis D or HIV

Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142298

Show 40 Study Locations

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	novartis ( novartis )
Study ID Numbers:	CLDT600A2303
First Received:	August 31, 2005
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00142298
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

Hepatitis B, Chronic

Hepatitis B

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on October 10, 2008