NCT01037166

Brief Summary

The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

16 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

Study Start

First participant enrolled

December 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
Last Updated

January 31, 2011

Status Verified

June 1, 2010

Enrollment Period

2.2 years

First QC Date

December 17, 2009

Last Update Submit

January 24, 2011

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

  • To assess the safety (the incidence of clinical adverse events and discontinuations due to adverse events)

    Week 52 (end of dosing) plus 5 days

  • To assess the proportion of subjects with reduction in HBV DNA by ≥ 2 log10 or to undetectable level (< 400 copies/mL)

    at Week 48

Secondary Outcomes (14)

  • Mean change from baseline in the log*10* HBV DNA measured by PCR assay for each entecavir dose (0.5 and 1 mg) at Week 48

    Baseline, Week 48

  • Proportion of subjects who achieve undetectable HBV DNA (<400 copies/mL) by PCR assay at Week 48

    Week 48

  • Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum at Week 48

    Week 48

  • Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb) at Week 48

    Week 48

  • Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT (<1.25 x ULN) at Week 48

    Week 48

  • +9 more secondary outcomes

Study Arms (2)

Entecavir (0.5 mg)

EXPERIMENTAL
Drug: Entecavir

Entecavir (1mg)

EXPERIMENTAL
Drug: Entecavir

Interventions

EntecavirDRUG

Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks

Also known as: Baraclude, BMS-200475
Entecavir (0.5 mg)Entecavir (1mg)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documentation of chronic hepatitis B infection by ALL of the following:
  • Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy
  • Patient who have received lamivudine therapy for 24 weeks or more, or patient who have documented YMDD mutation or other lamivudine-resistant mutation while on lamivudine
  • Documented HBV Viremia ≥ 10\*5: copies/mL
  • ALT in the range of 1.3 to 10 x ULN
  • Subjects must have well-compensated liver disease a) value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Local Institution

Aichi-Gun, Aichi-ken, 480-1195, Japan

Location

Local Institution

Nagoya, Aichi-ken, 466-8550, Japan

Location

Local Institution

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution

Chiba, Chiba, Japan

Location

Local Institution

Kurume, Fukuoka, Japan

Location

Local Institution

Ogaki-Shi, Gifu, 503-8502, Japan

Location

Local Institution

Asahikawa-Shi, Hokkaido, 070-0054, Japan

Location

Local Institution

Sapporo, Hokkaido, 060-0033, Japan

Location

Local Institution

Akashi-Shi, Hyōgo, 673-0848, Japan

Location

Local Institution

Morioka, Iwate, 020-8505, Japan

Location

Local Institution

Kyoto, Kyoto, Japan

Location

Local Institution

Sendai, Miyagi, Japan

Location

Local Institution

Okayama, Okayama-ken, 700-0082, Japan

Location

Local Institution

Minato-Ku, Tokyo, 105-0001, Japan

Location

Local Institution

Musashino-Shi, Tokyo, 180-0023, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

Related Publications (1)

  • Suzuki F, Toyoda J, Katano Y, Sata M, Moriyama M, Imazeki F, Kage M, Seriu T, Omata M, Kumada H. Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients. J Gastroenterol Hepatol. 2008 Sep;23(9):1320-6. doi: 10.1111/j.1440-1746.2008.05455.x. Epub 2008 Jun 28.

    PMID: 18554238BACKGROUND

Related Links

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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 21, 2009

Study Start

December 1, 2002

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

January 31, 2011

Record last verified: 2010-06

Locations

JP(16)