EUCTR2012-002516-51-GB
Active, not recruiting
Phase 1
An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study - The ZEUS Study
ConditionsHepatitis B re-infectionMedDRA version: 20.1 Level: PT Classification code 10058827 Term: Hepatitis B reactivation System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsZutectra
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatitis B re-infection
- Sponsor
- Biotest AG
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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