Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

This study has been completed.

First Received on June 21, 2005. Last Updated on March 1, 2007 History of Changes

Sponsor:	Idenix Pharmaceuticals
Collaborator:	Novartis
Information provided by:	Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00115245

Purpose

This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Telbivudine (LdT) Drug: Adefovir Dipivoxil	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Adefovir Adefovir dipivoxil Telbivudine

U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B
Detectable serum HBsAg at the Screening visit

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 dipivoxil, 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

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115245

Locations

United States, California

Los Angeles, California, United States

Pasadena, California, United States

San Francisco, California, United States
United States, Florida

Miami, Florida, United States
Australia

Clayton, Australia

Wooloongabba, Australia
Canada

Calgary, Canada

Toronto, Canada

Winnipeg, Canada
China

Hong Kong, China
France

Paris, France
Korea, Republic of

Seoul, Korea, Republic of
Singapore

Singapore, Singapore
Taiwan

Taipei, Taiwan
Thailand

Bangkok, Thailand

Sponsors and Collaborators

Idenix Pharmaceuticals

Novartis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Idenix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. Epub 2007 Oct 1.

ClinicalTrials.gov Identifier:	NCT00115245 History of Changes
Other Study ID Numbers:	NV-02B-018
Study First Received:	June 21, 2005
Last Updated:	March 1, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Adefovir dipivoxil
Adefovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on February 09, 2012