NCT00096785

Brief Summary

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Typical duration for phase_3

Geographic Reach
8 countries

24 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

November 15, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2004

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 6, 2010

Completed
Last Updated

August 10, 2010

Status Verified

June 1, 2010

Enrollment Period

1.1 years

First QC Date

November 15, 2004

Results QC Date

July 2, 2009

Last Update Submit

August 4, 2010

Conditions

Hepatitis BChronic Disease

Keywords

chronic hepatitis B infection

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12

    Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.

    Baseline, Week 12

Secondary Outcomes (9)

  • Change From Baseline in HBV DNA by PCR Assay at Week 48

    Baseline, Week 48

  • Viral Load Undetectable (HBV DNA <300 Copies/mL)

    Week 48

  • Alanine Aminotransferase (ALT) Normalization

    Week 48

  • HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections

    Week 12

  • HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate

    Week 12

  • +4 more secondary outcomes

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: entecavir

A2

ACTIVE COMPARATOR
Drug: adefovir

Interventions

entecavirDRUG

Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks

Also known as: Baraclude
A1
adefovirDRUG

Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks

A2

Eligibility Criteria

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

You may qualify if:

  • Chronic hepatitis B treatment naive
  • Compensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Local Institution

San Diego, California, United States

Location

Local Institution

San Francisco, California, United States

Location

Local Institution

Torrance, California, United States

Location

Local Institution

Miami, Florida, United States

Location

Local Institution

North Miami Beach, Florida, United States

Location

Local Institution

Baltimore, Maryland, United States

Location

Local Insitution

New York, New York, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Philadelphia, Pennsylvania, United States

Location

Local Institution

Dallas, Texas, United States

Location

Local Institution

Galveston, Texas, United States

Location

Local Institution

Edmonton, Alberta, Canada

Location

Local Institution

Vancouver, British Columbia, Canada

Location

Local Institution

Toronto, Ontario, Canada

Location

Local Institution

Chai Wan, Hong Kong

Location

Local Institution

Pokfulham, Hong Kong

Location

Local Institution

Tai Po, Hong Kong

Location

Local Institution

Jakarta, Indonesia

Location

Local Institution

Cebu, Philippines

Location

Local Institution

Manila, Philippines

Location

Local Institution

Singapore, Singapore

Location

Local Institution

Taichung, Taiwan

Location

Local Institution

Taoyan, Taiwan

Location

Local Institution

Bangkok, Thailand

Location

Related Publications (1)

  • Leung N, Peng CY, Hann HW, Sollano J, Lao-Tan J, Hsu CW, Lesmana L, Yuen MF, Jeffers L, Sherman M, Min A, Mencarini K, Diva U, Cross A, Wilber R, Lopez-Talavera J. Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir. Hepatology. 2009 Jan;49(1):72-9. doi: 10.1002/hep.22658.

    PMID: 19065670BACKGROUND

MeSH Terms

Conditions

Hepatitis BChronic DiseaseHepatitis B, Chronic

Interventions

entecaviradefovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis, Chronic

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 15, 2004

First Posted

November 16, 2004

Study Start

December 1, 2004

Primary Completion

January 1, 2006

Study Completion

April 1, 2008

Last Updated

August 10, 2010

Results First Posted

January 6, 2010

Record last verified: 2010-06

Locations

HK(3)PH(2)TH(1)SG(1)CA(3)ID(1)TW(2)US(11)