Clinical trial NCT01063036: Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With a Virologic Response at Week 48 - Treated Population
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population
timeFrame: Week 24, Week 96
measure: Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population
timeFrame: Baseline to Weeks 12, 24, 48, 96
measure: Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population
timeFrame: Weeks 24, 48, 96
measure: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline
timeFrame: Baseline to Weeks 24, 48, and 96
measure: Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline
timeFrame: Baseline, Weeks 24, 48, and 96
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline
timeFrame: Baseline, Weeks 24, 48, 96
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline
timeFrame: Baseline, Weeks 24, 48, and 96
measure: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population
timeFrame: Day 1 to last dose of study drug plus 5 days; up to Week 96
measure: Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population
timeFrame: Baseline to Weeks 48, 96
measure: Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population
timeFrame: Day 1 to last dose of study drug plus 5 days; up to Week 96
Other outcomes:
Locations:
city: Clichy
country: France
facility: Local Institution
city: Lyons Cedex 04
country: France
facility: Local Institution
city: Orleans Cedex 2
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heindelberg
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Tubingen
country: Germany
facility: Local Institution
city: Bagno A Ripoli (Fi)
country: Italy
facility: Local Institution
city: Bari
country: Italy
facility: Local Institution
city: Foggia
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Arnhem
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Kielce
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Burcuresti
country: Romania
facility: Local Institution
city: Timisoara
country: Romania
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: