NCT00393484

Brief Summary

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_4

Geographic Reach
1 country

15 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

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 18, 2010

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

October 26, 2006

Results QC Date

October 21, 2010

Last Update Submit

November 6, 2014

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Achieved a Virologic Response at Week 24

    Virologic response=Hepatitis B virus DNA \<300 copies/mL by polymerase chain reaction assay.

    At Week 24

Secondary Outcomes (13)

  • Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96

    At Weeks 24, 48, and 96

  • Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240

    At Weeks 24, 48, 96, 144, 192, and 240

  • Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24

    At Week 24

  • Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96

    At Weeks 24, 48, and 96

  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24

    Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period

  • +8 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Entecavir + Lamivudine placebo (0-96 weeks) Entecavir (96-240 weeks)

Drug: EntecavirDrug: Lamivudine Placebo

Arm B

ACTIVE COMPARATOR

Lamivudine + Entecavir placebo (0-96 weeks) Lamivudine (96-240 weeks)

Drug: LamivudineDrug: Entecavir Placebo

Interventions

EntecavirDRUG

Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)

Also known as: Baraclude, BMS-200475
Arm A
Lamivudine PlaceboDRUG

Capsules, Oral, 0 mg, once daily (0-96 weeks)

Arm A
LamivudineDRUG

Capsules, Oral, 100 mg, once daily (0-96 weeks) Tablets, Oral, 100 mg, once daily (96-240 weeks)

Arm B
Entecavir PlaceboDRUG

Tablets, Oral, 0 mg, once daily (0-96 weeks)

Arm B

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nucleoside and nucleotide-naive subjects with chronic HBV infection
  • Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
  • Detectable HBsAg
  • HBV DNA ≥ 105 copies/mL by PCR
  • ALT 1.3 to 10 x the ULN
  • HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Local Institution

Bucheon-si, 420-717, South Korea

Location

Local Institution

Busan, 602-739, South Korea

Location

Local Institution

Chuncheon, 200-704, South Korea

Location

Local Institution

Daegu, 700-721, South Korea

Location

Local Institution

Daegu, 705-030, South Korea

Location

Local Institution

Daejeon, 301-721, South Korea

Location

Local Institution

Guri-si, 471-020, South Korea

Location

Local Institution

Jeonju, 561-180, South Korea

Location

Local Institution

Seoul, 130-702, South Korea

Location

Local Institution

Seoul, 135-270, South Korea

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 136-705, South Korea

Location

Local Institution

Seoul, 138-040, South Korea

Location

Local Institution

Seoul, 150-950, South Korea

Location

Local Institution

Seoul, 152-050, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirLamivudine

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)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Results Point of Contact

Title
BMS 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 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

February 1, 2007

Primary Completion

January 1, 2009

Study Completion

September 1, 2013

Last Updated

November 26, 2014

Results First Posted

November 18, 2010

Record last verified: 2014-11

Locations

KR(15)