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Completed

NCT Number: NCT01020565

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

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

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Entecavir

Drug

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

Other names: Baraclude, BMS-200475

Primary outcomes

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

    Time frame: Week 52 (end of dosing) plus 5 days

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

    Time frame: Week 52 (end of dosing) plus 5 days

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

    Time frame: Week 48

Secondary outcomes

  1. Mean change from baseline in log10 HBV DNA measured by PCR assay for each entecavir dose (0.5 and 1 mg) at Week 48

    Time frame: Baseline, Week 48

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

    Time frame: Week 48

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

    Time frame: Week 48

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

    Time frame: Week 48

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

    Time frame: Week 48

  6. Proportion of subjects HBeAg-positive at baseline who have Complete Response [undetectable HBV DNA levels by PCR assay, negative for HBeAg and normal serum ALT] at Week 48

    Time frame: Week 48

  7. Proportion of subjects HBeAg-negative at baseline who have Complete Response [undetectable HBV DNA levels by PCR assay, remain negative for HBeAg and normal serum ALT] at Week 48

    Time frame: Week 48

  8. Proportion of subjects who achieve Complete Response, and remain Complete response for 24 weeks after stopping drug

    Time frame: Week 72

  9. Proportion of subjects w/ histological improvement in liver (improvement in necroinflammatory score (≥2 points decrease, Knodell HAI3 score) & no worsening of fibrosis (≥1 point increase, Knodell fibrosis score) at Wk 48 liver biopsy compared to baseline

    Time frame: Baseline, Week 48

  10. Changes in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis

    Time frame: Week 52

  11. Relationship between HBV isolates (genotypes A,B,C, etc.) at baseline and antiviral activity

    Time frame: Week 48, or at end of dosing (up to Week 52)

  12. Incidence of resistance mutations of HBV isolates in subjects who have a rise in HBV DNA (by ≥1 log above the nadir for that subject) while on study drug.

    Time frame: Week 48, or at end of dosing (up to Week 52)

  13. Mutation of HBV DNA polymerase at Week 48 from baseline

    Time frame: Baseline, Week 48

  14. Plasma concentrations of entecavir at selected time points during the treatment period

    Time frame: pre-dosing, Week 2 or 4, Week 12, Week 24 and Week 36

  15. Population pharmacokinetic assessment of entecavir developed from concentration-time data obtained from healthy subjects

    Time frame: pre-dosing, Week 2 or 4, Week 12, Week 24 and Week 36

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase II Study in Japan of the Safety and Antiviral Activity of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Nov 25, 2009
Registry last updated
Aug 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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