NCT01063036

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2010

Typical duration for phase_3

Geographic Reach
7 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
12 days until next milestone

Results Posted

Study results publicly available

February 13, 2014

Completed
Last Updated

December 15, 2014

Status Verified

November 1, 2014

Enrollment Period

2.5 years

First QC Date

February 3, 2010

Results QC Date

November 5, 2013

Last Update Submit

November 25, 2014

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Virologic Response at Week 48 - Treated Population

    Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.

    Week 48

Secondary Outcomes (10)

  • Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population

    Week 24, Week 96

  • Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population

    Baseline to Weeks 12, 24, 48, 96

  • Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population

    Weeks 24, 48, 96

  • Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline

    Baseline to Weeks 24, 48, and 96

  • Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline

    Baseline, Weeks 24, 48, and 96

  • +5 more secondary outcomes

Study Arms (1)

Entecavir + Tenofovir

EXPERIMENTAL
Drug: EntecavirDrug: Tenofovir

Interventions

EntecavirDRUG

Tablets, Oral, 1 mg, once daily, 96 weeks

Also known as: Baraclude®, BMS-200475
Entecavir + Tenofovir
TenofovirDRUG

Tablets, Oral, 300 mg, once daily, 96 weeks

Also known as: Viread®
Entecavir + Tenofovir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Local Institution

Clichy, 92110, France

Location

Local Institution

Lyon, 69317, France

Location

Local Institution

Orléans, 45067, France

Location

Local Institution

Strasbourg, 67000, France

Location

Local Institution

Berlin, 10969, Germany

Location

Local Institution

Berlin, 13353, Germany

Location

Local Institution

Hamburg, 20099, Germany

Location

Local Institution

Hamburg, 20246, Germany

Location

Local Institution

Hanover, 30625, Germany

Location

Local Institution

Heindelberg, 69120, Germany

Location

Local Institution

München, 81675, Germany

Location

Local Institution

Tübingen, 72076, Germany

Location

Local Institution

Bagno A Ripoli (Fi), 50012, Italy

Location

Local Institution

Bari, 70124, Italy

Location

Local Institution

Foggia, 71100, Italy

Location

Local Institution

Milan, 20122, Italy

Location

Local Institution

Amsterdam, 1105 AZ, Netherlands

Location

Local Institution

Arnhem, 6815 AD, Netherlands

Location

Local Institution

Rotterdam, 3015 CE, Netherlands

Location

Local Institution

Kielce, 25-317, Poland

Location

Local Institution

Krakow, 31-531, Poland

Location

Local Institution

Lodz, 91-347, Poland

Location

Local Institution

Wroclaw, 50-349, Poland

Location

Local Institution

Bucharest, 021105, Romania

Location

Local Institution

Burcuresti, 022328, Romania

Location

Local Institution

Timișoara, 300 002, Romania

Location

Local Institution

Barcelona, 08025, Spain

Location

Local Institution

Valencia, 46014, Spain

Location

Related Links

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirTenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 5, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2012

Study Completion

February 1, 2014

Last Updated

December 15, 2014

Results First Posted

February 13, 2014

Record last verified: 2014-11

Locations

FR(4)NL(3)RO(3)IT(4)PL(4)ES(2)DE(8)