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AN OPEN, MULTICENTRE, RANDOMISED PARALLEL GROUP CLINICAL STUDY TO COMPARE SAFETY AND EFFICACY OF TACROLIMUS FK506 WITH MONOCLONAL ANTI-IL2R ANTIBODIES DACLIZUMAB VS TACROLIMUS FK506 WITH STEROIDS AND EVALUATE PHARMACOKINETICS IN LIVER ALLOGRAFT RECIPIENTS RECEIVING SUBOPTIMAL LIVERS.

Conditions
PREVENTION OF REJECTION OF SUBOPTIMAL LIVERS IN LIVER ALLOGRAFT RECIPIENTS. COMPARE SAFETY AND EFFICACY OF TACROLIMUS FK506 WITH MONOCLONAL ANTI-IL2R ANTIBODIES DACLIZUMAB VS TACROLIMUS FK506 WITH STEROIDS AND EVALUATE PHARMACOKINETICS IN LIVER ALLOGRAFT RECIPIENTS RECEIVING SUBOPTIMAL LIVERS.
MedDRA version: 9.1Level: HLGTClassification code 10019654Term: Hepatic and hepatobiliary disorders
Registration Number
EUCTR2004-002924-16-IT
Lead Sponsor
FUJISAWA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

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

Not provided

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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