Photodynamic Therapy for Ulcerative Colitis

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

Primary: The primary study objective is to determine a clinical response as assessed by the Mayo score to low dose PDT in patients with moderate to severe active distal UC.

Secondary: The secondary study objectives are to assess the effect on inflammation and the safety and tolerability of low dose PDT in patients with moderate to severe active distal UC.

This is a multicenter, open phase II study that will enroll a maximum of 20 eligible patients with moderate to severe active distal UC. The first 10 eligible patients, the first cohort, will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no clinical response is observed in the first 7 eligible patients, the study will be stopped due to lack of efficacy. If at least 1 clinical response is observed in the first 7 patients, the first cohort will be completed to a total of 10 eligible patients

• Trial with medicinal product

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborator: Swiss National Science Foundation
• Treatments: Aminolevulinic Acid

Criteria

Inclusion criteria: ? An established and documented diagnosis of UC

• Moderate and severe active distal UC with a Mayo score of 6-10 and proctosigmoidoscopy score of 2

• Distal UC as assessed by proctosigmoidoscopy, i.e. major lesions between the sigmoid colon and rectum with lesions not extending the splenic flexure

• Glucocorticosteroids, aminosalicylates and certain immunosuppressants are permitted under specific conditions as defined in the concomitant medication section

Exclusion criteria: ? Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 weeks preceding SD1

• UC complications (e.g. strictures, pouchitis)

• Use of the following immunosuppressants in 12 weeks preceding SD1: cyclosporine, thalidomide derivatives, mycophenolate mofetil

• Use of antibiotics in 2 weeks preceding SD1

• Use of non steroidal anti-inflammatory drugs (NSAIDs) in 2 weeks preceding SD1

• Use of anti-tumor necrosis factor (TNF) or other biologics in 8 weeks preceding SD1

• Porphyria, erythropoietic protoporphyria or hypersensitivity to porphyrins

• Uncontrolled medical conditions, requiring surgical or pharmacological treatment

• Inadequate bone marrow reserve: White blood cell (WBC) < 3.5x109/L, neutrophils < 1.0x109/L, thrombocytes < 100x109/L, haemoglobin (Hb) < 8.5 g/dL or coagulation abnormalities

• Inadequate liver function: total bilirubin > 1.5 x upper limit of normal values aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), or alkaline phosphatase > 2.5 x upper limit of normal

• Have inadequate renal function, defined by serum creatinine > 250 µmol/L

• Serious concomitant disease (e.g. severe cardiovascular disease, chronic obstructive pulmonary disease)

• History of cancer < 5 years

• History of alcohol and/or drug abuses

• Pregnant or lactating women and fertile women unless surgically sterile or using one highly effective method + a barrier method till the end of the study (SD29)Female patients must not be pregnant or lactating