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Completed

NCT Number: NCT01037166

Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy

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

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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

Primary location

Local Institution, Aichi-Gun, Aichi-ken, Japan

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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
  • 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

Exclusion criteria

-

Treatment and study plan

Entecavir

Drug

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

Other names: Baraclude, BMS-200475

Primary outcomes

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

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

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

    Time frame: at Week 48

Secondary outcomes

  1. 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

    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 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 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

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

    Time frame: Week 52

  10. 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)

  11. 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)

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

    Time frame: Baseline, Week 48

  13. 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

  14. 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 With Incomplete Response to Current Lamivudine Therapy

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Dec 21, 2009
Registry last updated
Jan 31, 2011

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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