Effect of Tofacitinib on inflammation following pancreas transplantatio
- Conditions
- Therapeutic area: Body processes [G] - Immune system processes [G12]Ischaemia reperfusion injury and allograft pancreatitis.MedDRA version: 20.1 Level: PT Classification code 10066127 Term: Ischaemic pancreatitis System Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2017-002784-18-GB
- Lead Sponsor
- Clinical Trials and Research Governance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 20
•Participant is willing and able to give informed consent for participation in the trial.
•Male or Female, aged 18 years to 65 years.
•Participant is deemed surgically fit to proceed with combined solid organ pancreas kidney transplant
•In the Investigator’s opinion, is able and willing to comply with all trial requirements.
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
• Willing to undertake effective contraception for the duration of the trial.
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•Bladder drained pancreas transplants will be excluded
•Participant with life expectancy of less than 6 months
•Patients with Hepatitis B/C and HIV will be excluded
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
•Known allergy to Tofacitinib
•Does not speaks or understands English
•Use of contraindicated medication to Tofacitinib as per the appendix of inhibitors and inducers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method