Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B - Full Text View

Purpose

This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple timepoints over 12 weeks

Condition	Intervention	Phase
Hepatitis B, Chronic	Drug: telbivudine Drug: entecavir	Phase III

MedlinePlus related topics:

Hepatitis Hepatitis B

ChemIDplus related topics:

Hepatitis B Vaccines Entecavir Telbivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Open-Label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-Positive, Compensated Chronic Hepatitis B (CHB)

Further study details as provided by Novartis:

Primary Outcome Measures:

Characterize the change in mean hepatitis B virus (HBV) DNA level from Baseline to Week 12 for telbivudine and entecavir.

Secondary Outcome Measures:

• Change in mean HBV DNA level from Baseline to Weeks 2, 4, and 8
Characterization of very early viral kinetics through estimation of various parameters
Change in ALT (alanine aminotransferase) levels from Baseline to Week 12
The area under the curve (AUC) of HBV DNA change from Baseline to Week 12
% patients who are polymerase chain reaction (PCR) negative at Week 12
Safety assessed by adverse events and laboratory values

Enrollment:	43
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2008

Eligibility

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

Criteria

Inclusion Criteria:

Male or female, 18-70 years of age with documented compensated HBeAg-positive chronic hepatitis B
Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

Pregnant or breastfeeding
Unwilling to use double barrier method of contraception
Co-infected with HCV, HDV, HIV
Received hepatitis B therapy in the past
Use of immunomodulatory therapy in past 12 months
History of or symptoms of hepatic decompensation or pancreatitis
Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
Concurrent condition likely to preclude compliance with schedule of evaluations
Use of other investigational drugs within 30 days of enrollment
Abnormal laboratory values during screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412529

Locations


Korea, Republic of
	Novartis Facilities
	Seoul, Korea, Republic of
	Novartis
	Seoul, Korea, Republic of

Sponsors and Collaborators

Novartis

Idenix Pharmaceuticals

More Information

Study ID Numbers:	CLDT600A2407
First Received:	December 15, 2006
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00412529
Health Authority:	Korea: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Novartis:

hepatitis B

HBV

compensated chronic hepatitis B

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Entecavir

Digestive System Diseases

Hepatitis, Chronic

Hepatitis B, Chronic

Hepatitis B

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antiviral Agents

Hepadnaviridae Infections

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Novartis Idenix Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00412529