Photodynamic Therapy for Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01697670
• Date of registration: 28/09/2012
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Photodynamic Therapy for Ulcerative Colitis
• Scientific title: A Multicenter, Open Phase II Study to Assess the Effect and Safety of "Low Dose" Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis
• Date of first enrolment: September 2012
• Target sample size: 7
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01697670
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Switzerland

Contacts

• Name: Marianne Ortner, MD
• Affiliation: University Hospital Zurich, Division Gastroenterology

• Name: Marianne Ortner, MD

• Name: Maria Anna Ortner, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Photodynamic therapy with Gliolan

Primary Outcome(s)

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. [Time Frame: 4 weeks]

Secondary ID(s)

UC1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss National Science Foundation