A Study in Japan of the Safety and Antiviral Activity With Chronic Hepatitis B Infection

NCT01020565 | Completed Phase 2 DMC

• 1 other identifier: AI463-053
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of this study are to demonstrate that entecavir has antiviral activity with undetectable at Week 48, and to assess the safety and the pharmacokinetic in Japanese patients given entecavir at each dose of 0.1 and 0.5 mg for 52 weeks

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Incidence of clinical adverse events and discontinuations due to adverse events of entecavir at doses of 0.5 and 1 mg

  Week 52 (end of dosing) plus 5 days

• Incidence of laboratory abnormalities of entecavir at doses of 0.5 and 1 mg for 52 weeks

  Week 52 (end of dosing) plus 5 days

• Proportion of subjects with reduction in HBV DNA by ≥2 log10 or to undetectable level (<400 copies/mL) by PCR assay

  Week 48

Secondary Outcomes (15)

• Mean change from baseline in log10 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

Study Arms (2)

Entecavir (0.1 mg)

EXPERIMENTAL

Drug: Entecavir

Entecavir (0.5 mg)

EXPERIMENTAL

Drug: Entecavir

Interventions

Entecavir DRUG

Tablet, P.O., 0.1 OR 0.5 mg, once daily, 52 weeks

Also known as: Baraclude, BMS-200475

Entecavir (0.1 mg); Entecavir (0.5 mg)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Positive for HBeAg OR negative for HBeAg
• Documented HBV Viremia on 2 or more occasions and at screening visit: Viremia on sample drawn AND HBV DNA of ≥ 10\*5\* copies/mL by PCR assay at the screening visit
• ALT in the range of 1.3 to 10 x ULN

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Publications (1)

• Kobashi H, Takaguchi K, Ikeda H, Yokosuka O, Moriyama M, Imazeki F, Kage M, Seriu T, Omata M, Sakaguchi K, Shiratori Y. Efficacy and safety of entecavir in nucleoside-naive, chronic hepatitis B patients: phase II clinical study in Japan. J Gastroenterol Hepatol. 2009 Feb;24(2):255-61. doi: 10.1111/j.1440-1746.2008.05593.x.

  PMID: 19215336 BACKGROUND

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological 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: November 24, 2009
• First Posted: November 25, 2009
• Study Start: February 1, 2003
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: August 6, 2010

Record last verified: 2010-06