A Study to Compare Tenofovir Versus the Combination of Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B in Patients With Normal ALT - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00507507

Purpose

The main objective of the study is to evaluate the antiviral activity of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy for the treatment of chronic Hepatitis B

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: tenofovir disoproxil fumarate Drug: tenofovir disoproxil plus emtricitabine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Recombinant hepatitis B vaccine Hepatitis B Vaccines Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Suppression of HBV DNA < 400 copies/mL [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HBeAg seroconversion [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
Development of resistance mutations [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
HBsAg loss [ Time Frame: Week 144 ] [ Designated as safety issue: No ]

Enrollment:	126
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Tenofovir DF 300 mg + Emtricitabine 200 mg	Drug: tenofovir disoproxil plus emtricitabine tenofovir disoproxil 300 mg oral tablet once daily plus emtricitabine 200 mg oral capsule once daily Other Names: Viread Emtriva
Experimental: B Tenofovir DF	Drug: tenofovir disoproxil fumarate tenofovir disoproxil 300 mg oral tablet once daily plus matching emtricitabine placebo Other Name: Viread

Detailed Description:

The efficacy of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy will be evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes) and the development of any drug resistant mutations. The safety and tolerability of both tenofovir and tenofovir plus emtricitabine will also be evaluated by routine monitoring for adverse events and changes in laboratory parameters.

Eligibility

Ages Eligible for Study:	18 Years to 69 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 positive for IgG anti-HBc
18 through 69 years of age, inclusive
HBeAg positive
HBV DNA >= 10^8 copies/mL
ALT <= ULN
Willing and able to provide written informed consent
Negative serum beta-HCG (for females of childbearing potential only)
Calculated creatinine clearance >= 70 mL/min
Hemoglobin >=10 g/dL
Neutrophils >= 1,500 /mm3
No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)

Exclusion Criteria:

Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
Males and females of reproductive potential who are not willing to use an "effective" method of contraception during the study
Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 x ULN, PT >1.2 x 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
alpha-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
Known hypersensitivity to the study drugs, the metabolites or formulation excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507507

Show 45 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

Responsible Party:	Y. Sunila Reddy, Pharm.D./ Sr. Manager, Liver Disease Therapeutics, Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00507507 History of Changes
Other Study ID Numbers:	GS-US-203-0101
Study First Received:	July 25, 2007
Last Updated:	January 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

tenofovir
monotherapy
emtricitabine
combination
hepatitis B

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

Tenofovir disoproxil
Tenofovir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012