Destruction of cells separated from blood outside of the body using the drug 5-aminolevulinic and blue light for up to 10 patients with Crohns disease.

Phase 1

Conditions: Crohns disease
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2018-002422-23-NO

Lead Sponsor: Akershus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

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
a. HBI>7
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

Exclusion Criteria

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.