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Completed

NCT Number: NCT01022801

A Phase II Dose Response Study in Japan in Chronic Hepatitis B

To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22

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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

  • 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 with positive HBeAb,
  • Documented HBV Viremia on 2 or more occasions: Viremia on sample drawn AND HBV DNA of ≥ 40 MEq/mL by Quantiplex assay at the screening visit

Treatment and study plan

Entecavir

Drug

Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks

Other names: Baraclude, BMS-200475

Primary outcomes

  1. Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)

    Time frame: at Week 22

Secondary outcomes

  1. Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine

    Time frame: Through Week 24 (end of dosing) plus 5 days

  2. Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine

    Time frame: Through Week 24 (end of dosing) plus 5 days

  3. HBV DNA as measured by PCR (log10 copies/mL) at Week 22 [to demonstrate non-inferiority of at least one dose of entecavir as compared with lamivudine]

    Time frame: Week 22

  4. Proportion of subjects in each treatment group who achieve HBV DNA reduced by ≥2 log10 and/or below the limit of quantification (LOQ) (<400 copies/mL) as measured by PCR assay

    Time frame: Week 12, Week 22

  5. Proportion of subjects in each treatment group who achieve HBV DNA below the limit of detection (0.7 MEq/mL) of the Quantiplex branched DNA hybridization assay (Quantiplex assay)

    Time frame: Week 22

  6. Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)

    Time frame: Week 22

  7. Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline

    Time frame: Baseline, Week 22

  8. Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline

    Time frame: Week 22

  9. Proportion of HBeAg-positive subjects at baseline who achieve responder status (defined as: HBV DNA <0.7 MEq/mL by the Quantiplex assay; loss of HBeAg and normal serum ALT)

    Time frame: Week 22

  10. Proportion of HBeAg-negative subjects at baseline who achieve responder status (defined as HBV DNA <0.7 MEq/mL by the Quantiplex assay and normal serum ALT)

    Time frame: Week 22

  11. Incidence of genotypic resistance of HBV isolates in subjects who have a ε 1 log10 increase in HBV DNA as measured by PCR assay after achieving the lowest value while on study drug

    Time frame: Through Week 24

  12. Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response

    Time frame: Week 22

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) vs Lamivudine in Adults With Chronic Hepatitis B Infection

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Dec 1, 2009
Registry last updated
Feb 2, 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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