Extracorporeal photopheresis of patients with Crohns disease using 5- aminolevulinic acid. - twostepala

Akershus University Hospital0 个研究点目标入组 10 人开始时间: 2018年7月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Provision of informed consent
•2. Age above 18
•3. Male or female patient with active Crohn's disease (5)
•4. Inadequate response (a) or intolerance to biological therapy
•a. Inadequate response on ongoing treatment is defined as:
•i. Progressive disease: increasing HBI/Calprotectin/SES-CD and/or worsening of radiologic images after 6 months.
•ii. Stable disease: no-response after 6 months
•5. Active inflammation in the gut documented by
•b. Endoscopy with SES-CD > 6
•c. and/or inflammatory markers; fecal calprotectin and/or C-reactive
•protein (CRP).
•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 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1. Photosensitive comorbidities, porphyria or known hypersensitivity to 5-aminolevulinic acid or porphyrins
•2. Patients with aphakia
•3. Pregnant or breast feeding women. A negative urine pregnancy test must be demonstrated in female patients of child-bearing potential at the Screening Visit and before every treatment.
•4. Ongoing cardiac and pulmonary diseases or ASAT, ALAT, Bilirubin or INR value = 3x upper limit of normal or clinically significant ECG findings
•5. Subjects with polyneuropathy
•6. Uncontrolled infection or fever
•7. History of heparin-induced thrombocytopenia, absolute neutrophil
•count <1x109 L-1, platelet count <20x109 L-1
•8. Body weight below 40 kg
•9. Investigator considers subject unlikely to comply with study
•procedures, restrictions and requirements.
•10. History of any clinically significant disease or disorder which in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result or the patient's ability to participate in the study.

发起方

Akershus University Hospital