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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01037166
First received: December 17, 2009
Last updated: January 24, 2011
Last verified: June 2010

December 17, 2009
January 24, 2011
December 2002
February 2005   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01037166 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve undetectable HBV DNA (<400 copies/mL) by PCR assay at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Mutation of HBV DNA polymerase at Week 48 from baseline [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: Entecavir
Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
Other Names:
  • Baraclude
  • BMS-200475
  • Experimental: Entecavir (0.5 mg)
    Intervention: Drug: Entecavir
  • Experimental: Entecavir (1mg)
    Intervention: Drug: Entecavir
Suzuki F, Toyoda J, Katano Y, Sata M, Moriyama M, Imazeki F, Kage M, Seriu T, Omata M, Kumada H. Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients. J Gastroenterol Hepatol. 2008 Sep;23(9):1320-6. Epub 2008 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
February 2005
February 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documentation of chronic hepatitis B infection by ALL of the following:

    1. Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy
    2. 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
    3. 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:

-

Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01037166
AI463-052
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP