Status:
WITHDRAWN
Thiopurine Induced Pancreatitis in IBD Patients
Lead Sponsor:
Shaare Zedek Medical Center
Collaborating Sponsors:
Sydney Children's Hospitals Network
Christchurch Hospital
Conditions:
Pancreatitis
Inflammatory Bowel Diseases
Eligibility:
All Genders
5-60 years
Phase:
PHASE4
Brief Summary
Azathioprine (AZA) and its metabolite 6-mercaptopurine (6-MP) were developed over 50 years ago by Gertrude Elion and George Hitchings and were initially used clinically in the management of childhood ...
Detailed Description
The research protocol extends for up to 3.5 months, during which the participant will attend 5 clinic visits at Shaare Zedek Medical Centre: screening visit, week 0, week 4, week 8 and week 12. Durin...
Eligibility Criteria
Inclusion
- Patients diagnosed with IBD, treated previously with thiopurines, and ceased treatment due to suspected thiopurine-induced pancreatitis
- Ability to consent to and participate in the study and follow study procedures
- Age 5-60 years
Exclusion
- Previous severe pancreatitis requiring prolonged hospital admission or intensive care involvement, or Ranson's criteria ≥ 3
- No clinical need to reintroduce a thiopurine for management of IBD at the time of the study (e.g. stable on another medication, or mild phenotype of disease), based on clinical assessment of treating gastroenterologist
- Diagnosis of recurrent pancreatitis syndrome
- Diabetes mellitus or any other neuropathy which may dampen the clinical presentation of pancreatitis
- Known or suspected allergy or intolerance to thiopurines, besides previous pancreatitis
- Any other laboratory or clinical condition that the investigator considers clinically significant that could impact the outcome of the study or the safety of the patient.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02281799
Start Date
March 1 2015
End Date
January 1 2018
Last Update
March 18 2021
Active Locations (1)
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1
Shaare Zedek
Jerusalem, Israel, 91031