Hepatic allograft recipients for treatment of hepatitis B virus infection.
Conditions
Interventions
Product Name: HepeX-B
Pharmaceutical Form: Solution for infusion
Other descriptive name: libivirumab
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
XTL Biopharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients who are 18 years of age or older, 2. Patients who are at least 6 months post first orthotopic liver transplantation (living or cadaveric donor) for treatment of end-stage liver disease due to hepatitis B virus infection, 3. Patients who have received HBIg since transplantation and are on a stable regimen (i.e., same dose and frequency) for at least the 3 months immediately preceding study entry (Day 1). 4. Patients who have received treatment with an inhibitor of HBV polymerase for at least the 3 months immediately preceding study entry (Day 1) 5. Patients with undetectable HBsAg and HBV DNA concentrations on two consecutive tests at least one week apart during the screening period, 6. Female patients who are of childbearing potential, and males whose partners are women of childbearing potential, are required to use adequate contraception, and 7. Patients who are able to provide written informed consent. 8. Patients who successfully complete the initial 20-week treatment in the core trial are eligible for the 52-week extension phase. 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. Women who are pregnant or breastfeeding, 2. Patients who have received another organ transplant that requires immunosuppression, 3. Patients who are co-infected with hepatitis delta virus (HDV), hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV), 4. Patients with clinical conditions or diseases, which, in the judgment of the investigator, would place the patient at undue risk, interfere with study participation, or confound the results of the study, and/or 5. Patients who have participated in clinical studies in the 3 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be to compare the anti-viral effects of HepeX-B to Hepatitis B Immune Globulin (HBIg) as measured by serum concentrations of HBV DNA and HBsAg, in patients who have received hepatic allografts for treatment of hepatitis B virus infection. Virologic breakthrough is the primary measure of activity and is defined as the persistent recurrence of detectable serum concentrations of HBsAg and HBV DNA measured on 2 consecutive assessments 7 days apart. ;Secondary Objective: Secondary objectives will be to compare the anti-HBs trough concentrations, including the proportion of patients in each arm with trough levels of anti-HBs less than 200 IU/L at any time during the study, and to describe the safety of the reference and test agents.; Primary end point(s): The primary endpoint will be the proportion of patients in each treatment regimen without virologic breakthrough. Virologic breakthrough is defined as the persistent recurrence of detectable serum concentrations of HBsAg and HBV DNA measured on two consecutive assessments 7 days apart. Secondary endpoints will be a comparison of trough concentrations of anti-HBs antibodies, including the proportion of subjects in each arm of the study with trough concentrations of anti-HBs below 200 IU/L, and a description of safety (i.e., AEs and routine clinical laboratory results) throughout the study. | — |
Countries
United Kingdom
Outcome results
None listed