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

Sponsor:	Novartis Pharmaceuticals
Collaborator:	Idenix Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00412529

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 Hepatitis B	Drug: entecavir Drug: Telbivudine	Phase III

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)

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Entecavir Hepatitis B Vaccines Telbivudine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Characterize the change in mean hepatitis B virus (HBV) DNA level for telbivudine and entecavir. [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean HBV DNA level [ Time Frame: from Baseline to Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
Characterization of very early viral kinetics through estimation of various parameters [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
Change in ALT (alanine aminotransferase) levels [ Time Frame: from Baseline to Week 12 ] [ Designated as safety issue: No ]
The area under the curve (AUC) of HBV DNA change [ Time Frame: from Baseline to Week 12 ] [ Designated as safety issue: No ]
% patients who are polymerase chain reaction (PCR) negative [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
Safety assessed by adverse events and laboratory values [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	December 2006
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Telbivudine
B: Active Comparator	Drug: entecavir

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 or 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 medication likely to preclude compliance with schedule of evaluations
Use of other investigational drugs within 30 days of enrollment
Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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

Locations

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
The Catholic University of Korea
Seoul, Korea, Republic of
Korea University Medical Center_Anam
Seoul, Korea, Republic of
Gachon Univ. Gil Medical Center Hospital
Incheon, Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Holy Family Hospital_Bucheon
Bucheon,Kyunggi, Korea, Republic of

Sponsors and Collaborators

Novartis Pharmaceuticals

Idenix Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLDT600A2407
Study First Received:	December 15, 2006
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00412529 History of Changes
Health Authority:	Korea: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Novartis:

HBeAg-positive, chronic hepatitis B
telbivudine
entecavir
viral kinetics

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Hepatitis

Virus Diseases
Digestive System Diseases
Entecavir
Therapeutic Uses
Hepatitis B, Chronic
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on November 30, 2009