Clinical trial NCT00295607: Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
Official title: Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Liver Transplantation
Keywords: Tacrolimus
Liver Transplantation
Immunosuppression
Adult
Treatment Outcome
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

Detailed description: A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.

Eligibility criteria: Inclusion Criteria:

* Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis are eligible for the study.
* Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.

Exclusion Criteria:

* Recipient of multi-organ transplant
* Recipient of an auxiliary graft
* Patient is receiving ABO incompatible graft
* Patients requiring immunosuppressive treatment
* Patients requiring ongoing corticosteroid therapy.
* Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
* Patient or donor is known to be HIV positive.
* Patient is allergic or intolerant to study medication
* Patient is pregnant or breast-feeding.
* Patient has been previously enrolled in this study

Primary outcomes:
measure: Viral load of HCV at 12 months post transplantation
timeFrame: 12 months
Secondary outcomes:
measure: Biopsy-proven acute rejection
timeFrame: 12 months
measure: Acute rejection
timeFrame: 12 months
measure: Patient and graft survival
timeFrame: 12 months
measure: Incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Praha
country: Czech Republic
city: Besancon
country: France
city: Lyon
country: France
city: Nice
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Mainz
country: Germany
city: Bologna
country: Italy
city: Genova
country: Italy
city: Modena
country: Italy
city: Warszawa
country: Poland
city: Barakaldo
country: Spain
city: Madrid
country: Spain
city: Santiago
country: Spain
city: Goteborg
country: Sweden
city: London
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Physician
role: STUDY_DIRECTOR
References: