Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00409019

First received: December 7, 2006

Last updated: May 6, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	December 7, 2006
Last Updated Date	May 6, 2008
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00409019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
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	Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy
Official Title ^ICMJE	A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study)
Brief Summary	The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
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 Drug: Adefovir Drug: Tenofovir
Study Arm (s)	Not Provided
Publications *	Not Provided
* 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Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening. Other inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C, hepatitis D or HIV Patient previously received nucleoside(tide) therapy other than adefovir Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months Other exclusion criteria may apply.
Gender	Both
Ages	18 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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00409019
Other Study ID Numbers ^ICMJE	CLDT600AUS05
Has Data Monitoring Committee	Not Provided
Responsible Party	novartis, novatis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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