NCT00975091

Brief Summary

The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2004

Typical duration for phase_3

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

Study Start

First participant enrolled

May 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
Last Updated

February 2, 2010

Status Verified

November 1, 2009

Enrollment Period

3.3 years

First QC Date

September 8, 2009

Last Update Submit

January 29, 2010

Conditions

Chronic Hepatitis B Virus

Outcome Measures

Primary Outcomes (1)

  • The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events

    Through 3 years of dosing and up to 48 weeks of off treatment follow up

Secondary Outcomes (1)

  • The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort

    Through 3 years of dosing

Study Arms (2)

Entecavir 0.5

ACTIVE COMPARATOR
Drug: Entecavir

Entecavir 1.0

ACTIVE COMPARATOR
Drug: Entecavir

Interventions

EntecavirDRUG

Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started

Also known as: Baraclude, BMS-200475
Entecavir 0.5

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
  • ALT ≤ 15 x upper limit of normal
  • Compensated liver disease

You may not qualify if:

  • Coinfection with HIV, HCV, or HDV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 11, 2009

Study Start

May 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 2, 2010

Record last verified: 2009-11