CHRONIC HEPATITIS B VIRUS,TRANSPLANT MedDRA version: 8.1 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV)
Conditions
Interventions
Product Name: Entecavir
Product Code: BMS-200475
Pharmaceutical Form: Tablet
INN or Proposed INN: Entecavir
CAS Number: 209216-23-9
Current Sponsor code: BMS-200475-01
Concentration unit: mg milligram
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1/ Signed written informed consent 2/ Orthotopic Liver Transplant (OLT) patients with end-stage liver disease due to chronic HBV infection. 3/ HBV DNA = 50 IU/mL and =16 years of age or minimum age of consent in a given country) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after the last dose of investigational product. 2) WOCBP using a prohibited contraceptive method. At this time there are no known contraindicated contraceptives to entecavir. 3) Women who are pregnant or breastfeeding 4) Women with a positive pregnancy test on enrollment or prior to investigational product administration. 5) Sexually active fertile men not using effective birth control if their partners are WOCBP. 6) Patients with HCC who do not meet inclusion criteria or require systemic chemotherapy. 7) Recipient of ABO blood group incompatible organ, 8) Multi-organ or retransplant recipient, 9) Donor cold ischemia time > 20 hrs 10) Co-infection with human immunodeficiency virus (HIV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), or hepatitis C virus (HCV); 11) Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication); 12) Currently abusing illegal drugs or alcohol sufficient, in the Investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis; 13) Other serious medical conditions that might preclude completion of this study. 14) HBV DNA >=172 IU/mL (approximately >= 1000 copies/mL) by PCR prior to OLT 15) Serum alpha fetoprotein level > 100 ng/mL. If the alpha fetoprotein level is between 21 and 100 ng/mL, it must be repeated. If the repeat alpha fetoprotein level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma; 16) Known history of allergy to nucleoside analogues; 17) Unstable dose schedule (less than 4 weeks) for chronic medications. A consistent dosing schedule is recommended for the duration of study. 18) Poor peripheral venous access; 19) Unable to tolerate oral medication; 20) Prisoners or subjects who are compulsorily detained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: To determine the proportion of patients who experience virological recurrence of HBV at 72 weeks post-OLT as measured by HBV DNA by PCR >= 50 IU/mL (approximately >= 300 copies/mL).;Primary end point(s): The primary efficacy endpoint is to determine the proportion of patients who experience virological recurrence of HBV at 72 weeks post-OLT as measured by HBV DNA by PCR >=50 IU/mL (approximately >= 300 copies/mL). ;Secondary Objective: Efficacy: • Distribution of ALT levels at Week 72 • The proportion of patients who remain HBV DNA < 50 IU/mL (approximately < 300 copies/mL) at the end of post-dosing follow-up. • Loss of HBeAg and HBe seroconversion for baseline HBeAg positive subjects will be assessed as counts and proportions. • Loss of HBsAg and HBs seroconversion at 72 weeks post-OLT will be assessed as counts and proportions. Safety: • Distribution of total bilirubin at Week 72 • Distribution of prothrombin time (PT) at Week 72 • Episodes of liver rejection up to Week 72 • Re-transplant up to Week 72 • Safety as measured by the incidence of adverse events, laboratory abnormalities and discontinuation due to adverse event | — |
Countries
France, Italy, Spain
Outcome results
None listed