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Clinical Trials/EUCTR2012-002516-51-IT
EUCTR2012-002516-51-IT
Active, not recruiting
Not Applicable

An open, prospective, single arm study investigating efficacy and safety ofhuman hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study - The ZEUS Study

BIOTEST AG0 sites60 target enrollmentSeptember 21, 2012
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ConditionsHepatitis B re-infectionMedDRA version: 15.0Level: LLTClassification code 10058827Term: Hepatitis B reactivationSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsZutectra

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatitis B re-infection
Sponsor
BIOTEST AG
Enrollment
60
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 21, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
BIOTEST AG

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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •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

  • •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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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A clinical trial of Zutectra in patients who recently received a liver transplantEnsayo Clínico de Zutreca en pacientes que se han sometido a un trasplante de hígadoHepatitis B re-infecciónHepatitis B re-infectionMedDRA version: 14.1Level: LLTClassification code 10058827Term: Hepatitis B reactivationSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
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