EUCTR2015-005260-41-NLActive, not recruitingPhase 1
Efficacy of optimized thiopurine therapy in ulcerative colitis. - OPTIC
Academic Medical Centre0 sitesStarted: February 15, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
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 dysplasia/cancer
- •10. Extensive colonic resection, i.e. subtotal colectomy with less than 15 cm colon in situ
- •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 first
- •13.Known duodenal or ventricular ulcus
- •14. Substance abuse, such as alcohol (at least 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.Leucopenia (Neutrophil count below 1,8x10^9/L)
- •18.Thrombopenia (Platelets below 90x10^9/L)
- •19.Elevated liver enzymes (over 2x ULN)
- •20. Abnormal renal function (eGFR below 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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