Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Entecavir (Drug); Tenofovir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The purpose of this study is to show that the combination of entecavir and tenofovir, is
effective and well tolerated in chronic hepatitis B patients who have failed previous
treatment.
Clinical Details
Official title: A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With a Virologic Response at Week 48 - Treated Population
Secondary outcome: Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated PopulationChange From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e
antigen(HBeAg)-negative or HBeAg-positive
- Subjects must have a treatment failure to their current nucleoside/ nucleotide
treatment regimen
- Prior entecavir and/or tenofovir monotherapy is allowed
- Subjects must have compensated liver function
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
- Moderate or severe renal impairment
- Recent history of pancreatitis
- Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks
of being assigned to study drug into this study
- Prior entecavir/tenofovir combination therapy
Locations and Contacts
Local Institution, Clichy 92110, France
Local Institution, Lyons Cedex 04 69317, France
Local Institution, Orleans Cedex 2 45067, France
Local Institution, Strasbourg 67000, France
Local Institution, Berlin 10969, Germany
Local Institution, Berlin 13353, Germany
Local Institution, Hamburg 20246, Germany
Local Institution, Hamburg 20099, Germany
Local Institution, Hannover 30625, Germany
Local Institution, Heindelberg 69120, Germany
Local Institution, Munchen 81675, Germany
Local Institution, Tubingen 72076, Germany
Local Institution, Bagno A Ripoli (Fi) 50012, Italy
Local Institution, Bari 70124, Italy
Local Institution, Foggia 71100, Italy
Local Institution, Milano 20122, Italy
Local Institution, Amsterdam 1105 AZ, Netherlands
Local Institution, Arnhem 6815 AD, Netherlands
Local Institution, Rotterdam 3015 CE, Netherlands
Local Institution, Kielce 25-317, Poland
Local Institution, Krakow 31-531, Poland
Local Institution, Lodz 91-347, Poland
Local Institution, Wroclaw 50-349, Poland
Local Institution, Bucuresti 021105, Romania
Local Institution, Burcuresti 022328, Romania
Local Institution, Timisoara 300 002, Romania
Local Institution, Barcelona 08025, Spain
Local Institution, Valencia 46014, Spain
Additional Information
BMS Clinical Trial Information BMS clinical trial educational resource Investigator Inquiry form For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: May 2010
Last updated: November 25, 2014
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