Hepatitis B re-infection MedDRA version: 20.1 Level: PT Classification code 10058827 Term: Hepatitis B reactivation System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Zutectra
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: human hepatitis B immunoglobulin
Current Spo
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT 2. Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent 3. Male and female patients (age 18-75 years) 4. Patients with the diagnosis of liver failure with hepatitis B infection 5. Patients undergoing liver transplantation or re-transplantation 6. HBsAg negative on day 7 or on day 14 after OLT 7. HBV-DNA undetectable at OLT 8. Serum HBs antibody concentration on day 7 or on day 14 after OLT = 400 IU/l 9. Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study 10. Willingness to fill out patient diary 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Re-transplantation due to viral recurrence 2. Positive HIV or HCV test at time of transplantation 3. HBV-DNA positive at OLT 4. Patients having received organs from HBsAg positive donors 5. Pregnancy or unreliable contraceptive measures or lactation period (females only) 6. Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction) 7. Known intolerance to proteins of human origin 8. Participation in another interventional clinical trial within 90 days before entering the study or during the study and/or previous participation in this study (except screening failures) 9. Suspicion of drug and/or alcohol abuse 10. Inability or lacking motivation to participate in the study 11. Employee or direct relative of an employee of the CRO, the study site, or Biotest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of Zutectra in orthotopic liver transplanted patients; Secondary Objective: To demonstrate safety of Zutectra in orthotopic liver transplanted patients To assess the number of Hepatitis B virus re-infections of the liver (HBsAg positive and clinical symptoms) ;Primary end point(s): The failure rate after 24 weeks of treatment based on the trough levels of serum anti-HBs = 100 IU/l and the number of hepatitis B related re-infections in patients with trough levels of serum anti-HBs > 100 IU/l.;Timepoint(s) of evaluation of this end point: End of 24 weeks of treatment, or at a re-occurence of infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - The number of all patients with hepatitis B related infections will be assessed by monitoring of clinical signs, liver function and measurement of HBsAg and HBV-DNA. Efficacy - serum anti-HBs concentrations Safety - Adverse Event profile, heamatology, clinical chemistry and urinalysis ; Timepoint(s) of evaluation of this end point: Adverse Events - each visit Hepatitis serology - weekly for the first 8 weeks, then monthly until week 24. | — |
Countries
Italy, Spain, United Kingdom
Contacts
Public ContactZEUS Project Manager
AMS Advanced Medical Services
Outcome results
None listed