Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00376259

Purpose

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Condition	Intervention	Phase
Hepatitis B	Drug: telbivudine Drug: adefovir dipivoxil	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Lamivudine Hepatitis B Vaccines Adefovir dipivoxil Adefovir Telbivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multicenter, Randomized Study of Combination Therapy With Oral Telbivudine Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-Positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant

Further study details as provided by Novartis:

Primary Outcome Measures:

The primary objective of this study is to compare the proportion of lamivudine-resistant chronic hepatitis B patients experiencing Virologic Breakthrough by Week 96 following treatment with a combination of telbivudine plus adefovir versus adefovir alone [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1. To compare clinical efficacy outcomes in lamivudine-resistant, chronic hepatitis B patients who randomly receive either a combination of telbivudine plus adefovir or adefovir alone. [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	January 2007
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: telbivudine 600mg/day oral tablet for 52 weeks
B: Active Comparator	Drug: adefovir dipivoxil active comparator

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
Previous or current lamivudine treatment
HBV DNA > 6 log10 copies/mL
Evidence of viral breakthrough

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 has received any anti-HBV treatment for HBV infection other than lamivudine 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: NCT00376259

Locations

United States, California

San Mateo, California, United States
Novartis
San Diego, California, United States
Hong Kong

Pok Fu Lam, Hong Kong
Korea, Republic of

Seoul, Korea, Republic of
Taiwan
Novarits
Kaohsuing, Taiwan
Thailand

Bangkok, Thailand

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CLDT600A2304
Study First Received:	September 13, 2006
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00376259
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

lamivudine resistance
Hepatitis B virus

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic

Hepatitis B
Lamivudine
Hepatitis, Viral, Human
Adefovir dipivoxil
DNA Virus Infections
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Antiviral Agents
Hepadnaviridae Infections
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009