UnknownPhase 1

Photodynamic Therapy for Ulcerative Colitis

Switzerland7 participantsStarted 2012-09

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 aspartat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

to determine the proportion of patients with moderate to severe active distal UC with a clinical response to low dose PDT in patients at study day (SD) 8. A clinical response is defined as a total Mayo score <2 with no subscore >1.

Timeframe: 4 weeks

Trial details

NCT IDNCT01697670

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Contact for this trial

Marianne Ortner, MD

marianne.ortner@usz.ch

View on ClinicalTrials.gov More Ulcerative Colitis trials