NL-OMON47463CompletedPhase 3
Efficacy of optimized thiopurine therapy in ulcerative colitis. - OPTIC
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 59
Study Overview
Brief Summary
Trial ended prematurely
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Confirmed diagnosis of UC by endoscopy and histopathology
- •2. Patients between 18 and 80 years of age
- •3. Active disease, despite oral treatment with at least 2g/day 5-ASA
- •4. Treatment with oral corticosteroids is required
Exclusion Criteria
- •1. Prior treatment with thiopurines
- •2. Prior treatment with biologics (e.g. anti-TNF agents and vedolizumab)
- •3. Current pregnancy (a pregnancy test will be performed if necessary according
- •to the treating physician)
- •4. Chronic Obstructive Pulmonary Disease (COPD)
- •5. Acute coronary heart disease
- •6. (Bacterial) gastroenteritis has to be treated first
- •7. Coagulation disorders
- •8. Active malignancy
- •9. History of colonic focal high grade dysplasia or cancer
- •10. Extensive colonic resection, i.e. subtotal colectomy with <15 cm colon in
- •11. Concomitant therapy with drugs interfering with MP metabolism, like
- •allopurinol, ribavirin or anti-epileptics.
- •12. Known systemic fungal infections or parasitic infections have to be treated
- •13. Known duodenal or ventricular ulcus
- •14. Substance abuse, such as alcohol (> 80 gram/day * one standard glass
- •contains 10 gram of alcohol), I.V. drugs and inhaled drugs. If the subject has
- •a history of substance abuse, to be considered for inclusion into the protocol,
- •the subject must have abstained from using the abused substance for at least 2
- •years. Subjects receiving methadone within the past 2 years are also excluded
- •15. Positive tuberculosis screen (when a screening is performed at the
- •discretion of the treating physician)
- •16. Active hepatitis B virus or hepatitis C virus infection defined as a
- •positive anti-HCV, HBsAg and/or anti-HBcore screening.
- •17. Leukopenia (Neutrophil count < 1,8x10^9/L)
- •18. Thrombocytopenia (Platelets < 90x10^9/L)
- •19. Elevated liver enzymes (>2x ULN)
- •20. Abnormal renal function (eGFR< 30 mL/min)
- •21. Other conditions which in the opinion of the investigator may interfere
- •with the subject*s ability to comply with the study procedure
Investigators
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