Status:
COMPLETED
Comparison of Immunosuppression Protocols After LTx in Children
Lead Sponsor:
Children's Memorial Health Institute, Poland
Conditions:
Liver Transplantation
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
Open label, randomised, prospective, onecentre Investigator Driven Study: Comparison of two protocols of immunosuppression after liver Tx in children: A: Study group - FK506-MMF. Immunosupression pr...
Detailed Description
A: Study group FK506-MMF. Immunosupression protocol: Metylprednisolon 10 mg/kg intraoperatively i.v. FK506 Day 0 or 1 oraly (0,15 mg/kg/D in two doses). MMF max. dosage 30 mg/kg/D p.o. day 0 thro...
Eligibility Criteria
Inclusion
- Subjects who meet all of the following criteria are eligible for this study:
- Male or female patients, not older than 18 years old.
- Primary liver transplantation
- Patient is capable of understanding the purpose and risks of the study and has been informed both orally and in writing and has given informed consent
Exclusion
- Subjects who meet one or more of the following criteria are not eligible for this study:
- Female patients who are pregnant or are breast feeding
- Patients \> 18 years old
- Combined liver-kidney transplantation
- Recipient of second liver graft
- Patients are allergic, hyper-sensitive or intolerant to HCO-60 or structurally related compounds, macrolide antibiotics or tacrolimus.
- Patients with known HIV-anamnesis
- Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for another indication than the prophylaxis of liver graft rejection
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer.
- Patient is participating or has participated in another clinical study and/or is taking or has been taking an investigational drug in the past 28 days.
- Other reasons which depend on the assessment of the physician (no MMF will be given to patients with severe persistent hypersplenism (WBC \< 3.500/ml, platelets \< 50.000/ml)
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00195988
Start Date
September 1 2002
End Date
July 1 2006
Last Update
November 17 2005
Active Locations (1)
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1
Department of Pediatric Surgery and Organ Transplantation, CMHI
Warsaw, Poland, 04-743