Ulcerative ColitisPhase 1NCT01697670
Photodynamic Therapy for Ulcerative Colitis
A Phase 1 study testing Photodynamic therapy with Gliolan in people with Ulcerative Colitis, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Photodynamic therapy with Gliolan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Marianne Ortner, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
Department of Gastroenterology and Hepatology
Zurich
Maria Anna Ortner, MD, +41 792300891, ma.ortner@bluewin.ch
About this study
Official 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
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.
Read more
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
Read the detailed description
Subsequently, the following algorithm will apply:
- >3 clinical responders at SD8, then another 10 patients, the second cohort, will be exposed to the same PDT dose intensity
- <3 clinical responders, without adverse proctosigmoidoscopic observations at SD8, then the second cohort, will be exposed to the next higher PDT dose intensity 15 J/cm2
- <3 clinical responders, with adverse proctosigmoidoscopic observations at SD8, then the second cohort, will be exposed to the next lower PDT dose intensity 5 J/cm2
- The safety will be continuously evaluated throughout the study.
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.
Stopping rules:
Requirement for prohibited medication or surgical procedure Requirement to increase the dose of permitted medication SAE thought to be attributable to PDT Grade III and IV toxicities (CTC v3.0) thought to be attributable to PDT Patients request to be withdrawn Lost to follow-up
Investigational Medicinal Device:
All patients will drink 50 ml orange juice containing 15 mg/kg 5-aminolevulinic acid (5-ALA). After 3 hours, the lesions will be illuminated 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 seconds resulting in a total light dose of 10 J/cm2. The first cohort will be treated at a ligh
- Conditions
- Ulcerative Colitis
- Being tested
- Photodynamic therapy with Gliolan
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapy with GliolanDrug
Also called 5-aminolaevulinic acid (5-ALA)
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Photodynamic therapy with Gliolan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Marianne Ortner, MD, Principal investigator, University Hospital Zurich, Division Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697670
- Sponsor's protocol ID
- UC1001
- Status last verified
- Sep 2012
- First submitted
- 28 Sep 2012
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01697670
- Acronym / sponsor ID
- UC1001
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Subsequently, the following algorithm will apply:
- >3 clinical responders at SD8, then another 10 patients, the second cohort, will be exposed to the same PDT dose intensity
- <3 clinical responders, without adverse proctosigmoidoscopic observations at SD8, then the second cohort, will be exposed to the next higher PDT dose intensity 15 J/cm2
- <3 clinical responders, with adverse proctosigmoidoscopic observations at SD8, then the second cohort, will be exposed to the next lower PDT dose intensity 5 J/cm2
- The safety will be continuously evaluated throughout the study.
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.
Stopping rules:
Requirement for prohibited medication or surgical procedure Requirement to increase the dose of permitted medication SAE thought to be attributable to PDT Grade III and IV toxicities (CTC v3.0) thought to be attributable to PDT Patients request to be withdrawn Lost to follow-up
Investigational Medicinal Device:
All patients will drink 50 ml orange juice containing 15 mg/kg 5-aminolevulinic acid (5-ALA). After 3 hours, the lesions will be illuminated 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 seconds resulting in a total light dose of 10 J/cm2. The first cohort will be treated at a ligh
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy with Gliolan | Experimental | Drug: Photodynamic therapy with GliolanIntervention: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapy with GliolanAlso: 5-aminolaevulinic acid (5-ALA)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 | Drug | Photodynamic therapy with Gliolan |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Ortner, MD contact
Marianne Ortner, MD principal investigator
University Hospital Zurich, Division Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Photodynamic therapy with Gliolan in people with Ulcerative Colitis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Ortner, MD (marianne.ortner@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2012.