Skip to main content
OpenTrials
Completed

NCT Number: NCT01037062

An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

Completed

Looking for future studies?

Notify Me

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
  • ALT ≤ 10 x upper limit of normal;
  • Subjects must have well-compensated liver disease according to ALL of the following criteria;
  • Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
  • Serum albumin ≥ 3 g/dL (≥ 30 g/L)
  • Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)

Exclusion criteria

  • Sex and Reproductive Status Exceptions
  • Target Disease Exceptions
  • Medical History and Concurrent Diseases

Treatment and study plan

Entecavir

Drug

Tablet, P.O. 0.5, 1 mg, once daily

Other names: Baraclude, BMS-200475

Primary outcomes

  1. To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

    Time frame: 24 weeks

Secondary outcomes

  1. Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort

    Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing

  2. Incidence of laboratory abnormalities of of entecavir for each cohort

    Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing

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

    Time frame: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing

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

    Time frame: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing

  5. Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48

    Time frame: Day 1, Week 48

  6. Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ)

    Time frame: Day 1, Week 12, 24, and subsequent 24 week during dosing

  7. Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion

    Time frame: Week 8, 16, 24 post dosing

  8. Proportion of subjects negative for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ and normal ALT and remain negative for HBeAg

    Time frame: Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing

  9. Proportion of subjects who achieved Complete Response during therapy, who have sustained Complete Response for 24 weeks after stopping drug

    Time frame: 24 Week post dosing

  10. Proportion of subjects with histological improvement in the liver at Wks 48 & 96 [improvement in necroinflammatory score and no worsening of fibrosis at Wks 48 & 96 liver biopsy compared to baseline & to baseline in previous study]

    Time frame: Week 48, 96

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

    Time frame: Week 48 & Week 96

  12. Incidence of genotypic changes in HBV DNA polymerase conferring resistance to entecavir in subjects with confirmed ≥1 log10 increase in HBV DNA from nadir on treatment

    Time frame: Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Previous Phase II Studies in Japan But Who Require Further Treatment

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.