AN OPEN, RANDOMISED, MULTICENTRE, EXPLORATORY CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF TACROLIMUS IN COMBINATION WITH MONOCLONAL ANTI-IL2R ANTIBODIES OR STEROIDS IN HCV POSITIVE PATIENTS UNDERGOING LIVER ALLOGRAFT TRANSPLANTATION - CHASE (C Hepatitis and Steroid Elimination)
- Conditions
- Patients 18 to 65 years of age who will undergo primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis. As the primary endpoint of the study is the viral load of HCV the below indicated code-level refers to 'Hepatitis C positive'MedDRA version: 7.0Level: LLTClassification code 10057394
- Registration Number
- EUCTR2004-004561-14-GB
- Lead Sponsor
- Astellas Pharma Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1.Male or female patient of any race, 18 to 65 years of age.
2.HCV positive patient who is undergoing primary orthotopic liver or split liver allograft transplantation for HCV-cirrhosis and is receiving a liver transplant from cadaveric donor.
3.Female patient of child bearing potential must have a negative pregnancy test prior to enrolment and must agree to practice effective birth control during the study.
4.Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed by an independent person.
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) no
F.1.3.1 Number of subjects for this age range
1.Recipient of multi-organ transplant or previous organ transplant (including liver re-transplantation).
2.Recipient of an auxiliary graft or in whom an investigational bio-artificial liver (cell system) has been used.
3.Patient is receiving AB0 incompatible graft.
4.Patients requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment (azathioprine and/or steroids only) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed.
5.Patient is requiring ongoing corticosteroid therapy.
6.Patients with malignancies or a history of malignancy within the last 5 years, with the exception of those with basal or squamous cell carcinoma of the skin that has been treated successfully. Patients transplanted with hepatocellular carcinoma can be included if they meet the following criteria:
•= 3 nodes
•no node larger than 5 cm
•no metastases
•no vascular tumoral invasion
Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study.
7.Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
8.Patient or donor is known to be HIV positive.
9.Patient is allergic or intolerant to steroids, macrolide antibiotics, tacrolimus and daclizumab or to any excipients of the study medication.
10.Patient is pregnant or breast-feeding.
11.Patient has been previously been enrolled in this study.
12.Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational / non-registered drug within the last 28 days before entry into this study.
13.Patient with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
14.Patient is unlikely to comply with the visits scheduled in the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this exploratory study is to evaluate the impact of the elimination of the steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis. A comparison will be made between two regimens which both include tacrolimus, one with standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic immunosuppression and anti-rejection treatment.;Secondary Objective: None;Primary end point(s): The primary endpoint of the study is the viral load of HCV at 12 months post transplantation.
- Secondary Outcome Measures
Name Time Method