Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00805675

Purpose

The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.

Condition	Intervention	Phase
Hepatitis B Virus	Drug: Telbivudine Drug: Tenofovir Drug: Telbivudine plus tenofovir	Phase II

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Telbivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Randomized, Open-Label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Monotherapy Given Over 12 Weeks on the Kinetics of Hepatitis B Virus DNA in Adults With HBeAg Positive Compensated CHB

Further study details as provided by Novartis:

Primary Outcome Measures:

The primary variable is the reduction of HBV DNA level over 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in 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: Week 12 ] [ Designated as safety issue: No ]
% of patients who are PCR negative [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
% of patients who achieve HBeAg loss and HBeAg seroconversion [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Telbivudine 600 mg monotherapy: Experimental	Drug: Telbivudine
Tenofovir disproxil fumarate 300 mg monotherapy: Active Comparator	Drug: Tenofovir
Telbivudine 600 mg and Tenofovir 300 mg: Active Comparator	Drug: Telbivudine plus tenofovir

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
Age < 40 years old
HBeAg positive
HBV DNA > or = to 107 copies/mL by Abbott real-time PCR
ALT < or = to 1 ULN
Willing and able to provide written informed consent
No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)
Is willing and able to comply with the study drug regimen and all other study procedures and requirements
Is willing and able to provide written informed consent before any study assessment is perform

Exclusion Criteria:

Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × ULN, PT > 1.2 × ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
Received interferon (pegylated or not) therapy within 6 months of the screening visit
α-fetoprotein > 50 ng/mL
Evidence of hepatocellular carcinoma (HCC)
Co-infection with HCV (by serology), HIV, or HDV.
Significant renal, cardiovascular, pulmonary, or neurological disease.
Received solid organ or bone marrow transplantation.
Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
Has proximal tubulopathy.
Use of other investigational drugs at the time of enrollment, or within 30 days
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Is pregnant or breastfeeding.
Is a women of child-bearing potential (WOCBP).
Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805675

Locations

China
Department of Medicine, Queen Mary Hospital	Recruiting
Hong Kong, China
Contact: George Lau, MD +852-2855 3578 gkklau@netvigator.com

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLDT600AHK01
Study First Received:	December 9, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00805675
Health Authority:	Hong Kong: Department of Health

Keywords provided by Novartis:

Chronic HBV
Asian adult subjects with chronic HBV, in immune tolerant phase, and positive for hepatitis B e antigen (HBeAg)

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B

Tenofovir
Hepatitis, Viral, Human
DNA Virus Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 16, 2009