A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

This study has been completed.

Sponsor:

Collaborator:

Novartis

Information provided by:

Idenix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00057265

First received: March 28, 2003

Last updated: November 14, 2007

Last verified: November 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	March 28, 2003
Last Updated Date	November 14, 2007
Start Date ^ICMJE	February 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: July 12, 2007)	Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00057265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 12, 2007)	Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
Official Title ^ICMJE	A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
Brief Summary	This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: telbivudine or lamivudine
Study Arm (s)	Not Provided
Publications *	Zeuzem S, Gane E, Liaw YF, Lim SG, DiBisceglie A, Buti M, Chutaputti A, Rasenack J, Hou J, O'Brien C, Nguyen TT, Jia J, Poynard T, Belanger B, Bao W, Naoumov NV. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J Hepatol. 2009 Jul;51(1):11-20. Epub 2009 Feb 12. Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, Chen Y, Heathcote EJ, Rasenack J, Bzowej N, Naoumov NV, Di Bisceglie AM, Zeuzem S, Moon YM, Goodman Z, Chao G, Constance BF, Brown NA; Globe Study Group. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med. 2007 Dec 20;357(25):2576-88.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2. Patient previously received lamivudine 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.
Gender	Both
Ages	16 Years to 70 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Korea, Republic of, Spain, Thailand, Turkey, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00057265
Other Study ID Numbers ^ICMJE	NV-02B-007
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Idenix Pharmaceuticals
Collaborators ^ICMJE	Novartis
Investigators ^ICMJE	Not Provided
Information Provided By	Idenix Pharmaceuticals
Verification Date	November 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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