Status:
COMPLETED
A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant
Lead Sponsor:
Biotest
Collaborating Sponsors:
AMS Advanced Medical Services GmbH
Conditions:
Hepatitis B
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative tr...
Eligibility Criteria
Inclusion
- Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT
- Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent
- Male and female patients (age 18-75 years)
- Patients with the diagnosis of liver failure with hepatitis B infection
- Patients undergoing liver transplantation or re-transplantation
- HBsAg negative on day 7 or on day 14 after OLT
- HBV-DNA undetectable at OLT
- Serum HBs antibody concentration on day 7 or on day 14 after OLT ≥ 400 IU/l
- Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study
- Willingness to fill out patient diary
Exclusion
- Re-transplantation due to viral recurrence
- Positive HIV or HCV test at time of transplantation
- HBV-DNA positive at OLT
- Patients having received organs from HBsAg positive donors
- Pregnancy or unreliable contraceptive measures or lactation period (females only)
- Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
- Known intolerance to proteins of human origin
- 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)
- Suspicion of drug and/or alcohol abuse
- Inability or lacking motivation to participate in the study
- Employee or direct relative of an employee of the CRO, the study site, or Biotest
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01856413
Start Date
December 1 2012
End Date
September 1 2014
Last Update
March 25 2015
Active Locations (16)
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1
Hopital de la Croix Rousse
Lyon, France, 69004
2
Hôpital Paul Brousse
Villejuif, France, 94804
3
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
4
S. Orsola Hospital
Bologna, Italy, 40138