Photodynamic Therapy for Ulcerative Colitis

NCT01697670 | Unknown Phase 1 DMC

• 1 other identifier: UC1001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall duration of 9 weeks per patient. It is foreseen to have at least 3 participating investigational sites to complete accrual of the first cohort in 3 months, and the second cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites will be asked for participation. Hence the study duration from study initiation until last patient whom completed the study is 8 months to reach the primary analysis of the study. The follow-up analysis will be completed about 3 months later.

  4 weeks

Study Arms (1)

Photodynamic therapy with Gliolan

EXPERIMENTAL

Intervention: Laser light illumination with a cylindrical light diffuser (Model RD, Medlight SA) is performed 3 hours after administration of 15 mg/kg 5-aminolevulinic acid (5-ALA, Gliolan)

Drug: Photodynamic therapy with Gliolan

Interventions

Photodynamic therapy with Gliolan DRUG

Laser light illumination with red light at 635 nm using a cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 s resulting in a total light dose of 10 J/cm2 is performed 3 hours after administration of 15mg/kg bodyweight Gliolan

Also known as: 5-aminolaevulinic acid (5-ALA)

Photodynamic therapy with Gliolan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Department of Gastroenterology and Hepatology

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Photochemotherapy; Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Marianne Ortner, MD

  University Hospital Zurich, Division Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Ortner, MD

CONTACT

marianne.ortner@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 5, 2012

Record last verified: 2012-09

Locations

CH (1)