Crohn DiseasePhase 1/2NCT04164849
Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid
A Phase 1/2 study testing 5-aminolevulinic acid, Blue light photopheresis and Transfusion in people with Crohn Disease, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
In the clinical trial the investigators will assess efficacy, safety and tolerability after single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) photopheresis in patients with active crohns disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- 5-aminolevulinic acid, Blue light photopheresis and Transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- 22 Nov 2019to 31 Oct 2023
- Phase
- Phase 1/2
- 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
Who may be able to join
- Provision of informed consent
- Age above 18
- Male or female patient with active Crohn's disease (6)
- Women of childbearing potential (WOCBP) will have to use highly effective methods of contraception throughout the entire study.
- Inadequate response (a) or intolerance to biological therapy
- Inadequate response on ongoing treatment is defined as: i. Progressive disease: increasing Harvey Bradshaw Index/Calprotectin/Simple Endoscopic Score for Crohns Disease and/or worsening of radiologic images after 6 months.
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- Stable disease: no-response after 6 months
- Active inflammation in the gut documented by
- Harvey Bradshaw Index >5 and
- Endoscopy with Simple Endoscopic Score for Crohns Disease equal to or above 6 points or equal to or above 4 points if only isolated ileitis is present and/or
- Inflammatory marker; fecal calprotectin > 250 and/or C reactive protein > 5
Who cannot join
- Photosensitive comorbidities, porphyria or known hypersensitivity to 5-aminolevulinic acid or porphyrins
- Patients with aphakia
- Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in female patients of child-bearing potential at the Screening Visit and before every treatment.
- Ongoing cardiac and pulmonary diseases or aspartate transaminase alanine aminotransferase, Bilirubin or International Normalized Ratio value ≥ 3x upper limit of normal or clinically significant electrocardiogram findings
- Subjects with polyneuropathy
- Uncontrolled infection or fever
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- History of heparin-induced thrombocytopenia, absolute neutrophil count <1x109, platelet count <20x10 9
- Body weight below 40 kg
- Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.
- Presence of other gastrointestinal diseases potentially influencing the study endpoints
- History of any clinically significant disease or disorder which in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result or the patient's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
In the clinical trial the investigators will assess efficacy, safety and tolerability after single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) photopheresis in patients with active crohns disease. The study is a proof-of-concept pilot with up to 10 included patients where every patient will get active treatment. The use of 5-aminolevulinic acid in combination with blue-light photopheresis is a first-in-human trial. Primary endpoints include clinical response and adverse events (safety). Secondary endpoints include endoscopic improvement, quality of life questionnaires, faecal calprotectin, C-reactive protein and mechanisms of action (differences in t-cells and other cells before and after treatment). All patients will get treatment every 2 weeks for 10 weeks (6 treatments-induction) with evaluation at week 13. If any effect on week 13 eligible for study extension with treatment every 4 weeks for up to 12 months for the first 5 patients. The latter 5 patients will be referred to standard of care on the week 13 visit. Through the study the investigators will see if this kind of photopheresis is safe and can be an option for a larger randomized-controlled-trial. In addition the investigators will see if photopheresis as an option can be further developed for other diseases as well (ie other T-cell mediated diseases or patients already receiving photopheresis as a treatment).
- Conditions
- Crohn Disease
- Being tested
- 5-aminolevulinic acid, Blue light photopheresis, Transfusion, Continuous Mononuclear Cell Collection (CMNC)
- Keywords
- Crohns Disease, Photopheresis, 5-aminolevulinic acid, Gliolan, UVA-PIT
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-aminolevulinic acidDrug
5-aminolevulinic acid (30 mg/ml) will be added to mononuclear cells in a dose of 3 millimolar and incubated for 1 hour
Blue light photopheresisProcedure or surgery
The mononuclear cells incubated with 5-aminolevulinic acid for 1 hour will be exposed to blue light.
TransfusionProcedure or surgery
The treated cells are transferred back to the patient as a standard blood transfusion
Continuous Mononuclear Cell Collection (CMNC)Procedure or surgery
The mononuclear cells are collected using the Spectra Optia with the Continuous Mononuclear Cell Collection protocol. 90 ml of mononuclear cells will be collected and 100 ml of 0,9% saline will be added to dilute the cells before incubation with drug and photopheresis.
| Study group | Role | What they receive |
|---|---|---|
| 5-ALA photopheresis | Experimental | All patients will receive 5-aminolevulinic acid (5-ALA) in combination with blue light photopheresis. The investigators will collect mononuclear cells by connecting patient to Spectra Optia with CMNC (continuous mononuclear cell collection protocol), and these cells will include active T-lymphocytes. 5-ALA will be incubated for 1 hour to produce photoactive protoporphyrin-IX (PpIX) before light exposure. Receives: Drug: 5-aminolevulinic acid; Procedure: Blue light photopheresis; Procedure: Transfusion; Procedure: Continuous Mononuclear Cell Collection (CMNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Clinical response (Harvey Bradshaw Index change > 3 from baseline or less than 4 points)
Measured: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and 3 months after last treatment
Safety and tolerability adverse events
Frequency, seriousness and intensity of adverse events
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability Electrocardiogram-PR interval
Changes in PR interval before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability Electrocardiogram-PR segment
Changes in PR segment before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability Electrocardiogram-QT interval
Changes in QT interval before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability Electrocardiogram-ST segment
Changes in ST segment before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability Electrocardiogram-T wave
Changes in T wave before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability Electrocardiogram-QRS complex
Changes in QRS complex before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability vital signs
Vital signs (heart rate) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Safety and tolerability blood pressure
Vital signs (systolic and diastolic blood pressure) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Alkaline phosphatase
Changes in serum alkaline phosphatase (U/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Aspartate transferase
Changes in serum aspartate transferase(U/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Alanine aminotransferase
Changes in serum alanine aminotransferase (U/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Albumin
Changes in Serum Albumin (g/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Bilirubin
Changes in Serum Bilirubin (micromol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Gamma glutamyltransferase
Changes in Serum gamma glutamyltransferase (U/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
White cell count
Changes in Blood White cell count (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Neutrophil granulocytes
Changes in Blood neutrophil granulocytes (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Lymphocytes
Changes in Blood Lymphocytes (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Monocytes
Changes in Blood Monocytes (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Eosinophile granulocytes
Changes in Blood Eosinophile granulocytes (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Basophile granulocytes
Changes in Blood Basophile granulocytes (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Platelet count
Changes in Blood Platelet count (10^9/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Mean Cell Volume
Changes in Blood Mean Cell Volume (fL) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Mean Cell hemoglobin
Changes in Blood Mean Cell hemoglobin (picogram) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
International Normalized Ratio
Changes in Blood International Normalized Ratio (0,8-1,2) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Hemoglobin
Changes in Blood Hemoglobin (g/dL) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Calcium
Changes in Serum Calcium (millimol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Potassium
Changes in Serum Potassium (millimol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Sodium
Changes in Serum Sodium (millimol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Creatinin
Changes in Serum Creatinine (micromol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Lactate Dehydrogenase
Changes in Serum Lactate Dehydrogenase (U/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Cholesterol
Changes in Serum Cholesterol (millimol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Total Protein
Changes in Serum Total Protein (g/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Carbamide
Changes in Serum Carbamide (millimol/L) before and after treatment
Measured: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Secondary outcomes (8)
CD4+ and CD8+ T cell subpopulations
Number of CD4+ and CD8+ T cell subpopulations before and after treatment assessed by flow cytometry.
Measured: Week 0, 10 (all patients) and 50 (patients of the first 5 subjects eligible for study extension)
Apoptosis and necrosis
Number of cells in apoptosis or necrosis before and after treatment assessed by flow cytometry
Measured: Week 0, 10 (all patients) and 50 (patients of the first 5 subjects eligible for study extension)
Clinical remission
Harvey Bradshaw Index < 5 points
Measured: Week 13 and/or sustained/delayed response in week 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and 3 months after last treatment.
Endoscopic efficacy
Simple Endoscopic Score for Crohns Disease >49 % improvement or < 3 (endoscopic remission)
Measured: Week 13 (all patients) and 64 (patients of the first 5 subjects eligible for study extension) with baseline visit as reference.
Faecal calprotectin
Change from baseline
Measured: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Concentration of C reactive protein in blood
Change from baseline
Measured: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Quality of life questionnaire Short-Form 36 (SF-36)
Change of both total and subscores of SF-36 from baseline. Min 0 Max 100. Higher value is better quality of life.
Measured: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Quality of life questionnaire Inflammatory Bowel Disease Questionnaire (IBDQ)
Change of both total and subscores of IBDQ from baseline. Min 32 Max 224. Higher value is better quality of life.
Measured: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start22 Nov 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A combined phase 1/2 pilot study with emphasize on safety/tolerability but also clinical efficacy/effect
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Jørgen Jahnsen, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164849
- Sponsor's protocol ID
- twostepala
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 2019
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid
- ClinicalTrials.gov ID
- NCT04164849
- Acronym / sponsor ID
- twostepala
- Conditions
- Crohn Disease
- Keywords
- Crohns Disease, Photopheresis, 5-aminolevulinic acid, Gliolan, UVA-PIT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Nov 2019 (actual)
- 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.
In the clinical trial the investigators will assess efficacy, safety and tolerability after single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) photopheresis in patients with active crohns disease. The study is a proof-of-concept pilot with up to 10 included patients where every patient will get active treatment. The use of 5-aminolevulinic acid in combination with blue-light photopheresis is a first-in-human trial. Primary endpoints include clinical response and adverse events (safety). Secondary endpoints include endoscopic improvement, quality of life questionnaires, faecal calprotectin, C-reactive protein and mechanisms of action (differences in t-cells and other cells before and after treatment). All patients will get treatment every 2 weeks for 10 weeks (6 treatments-induction) with evaluation at week 13. If any effect on week 13 eligible for study extension with treatment every 4 weeks for up to 12 months for the first 5 patients. The latter 5 patients will be referred to standard of care on the week 13 visit. Through the study the investigators will see if this kind of photopheresis is safe and can be an option for a larger randomized-controlled-trial. In addition the investigators will see if photopheresis as an option can be further developed for other diseases as well (ie other T-cell mediated diseases or patients already receiving photopheresis as a treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A combined phase 1/2 pilot study with emphasize on safety/tolerability but also clinical efficacy/effect
| Arm | Type | Receives |
|---|---|---|
| 5-ALA photopheresis | Experimental | Drug: 5-aminolevulinic acid, Procedure: Blue light photopheresis, Procedure: Transfusion, Procedure: Continuous Mononuclear Cell Collection (CMNC)All patients will receive 5-aminolevulinic acid (5-ALA) in combination with blue light photopheresis. The investigators will collect mononuclear cells by connecting patient to Spectra Optia with CMNC (continuous mononuclear cell collection protocol), and these cells will include active T-lymphocytes. 5-ALA will be incubated for 1 hour to produce photoactive protoporphyrin-IX (PpIX) before light exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of informed consent
- Age above 18
- Male or female patient with active Crohn's disease (6)
- Women of childbearing potential (WOCBP) will have to use highly effective methods of contraception throughout the entire study.
- Inadequate response (a) or intolerance to biological therapy
Key exclusion criteria (11 listed)
- Photosensitive comorbidities, porphyria or known hypersensitivity to 5-aminolevulinic acid or porphyrins
- Patients with aphakia
- Pregnant or breast-feeding women. A negative urine pregnancy test must be demonstrated in female patients of child-bearing potential at the Screening Visit and before every treatment.
- Ongoing cardiac and pulmonary diseases or aspartate transaminase alanine aminotransferase, Bilirubin or International Normalized Ratio value ≥ 3x upper limit of normal or clinically significant electrocardiogram findings
- Subjects with polyneuropathy
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 |
|---|---|---|
| 5-aminolevulinic acid5-aminolevulinic acid (30 mg/ml) will be added to mononuclear cells in a dose of 3 millimolar and incubated for 1 hour | Drug | 5-ALA photopheresis |
| Blue light photopheresisThe mononuclear cells incubated with 5-aminolevulinic acid for 1 hour will be exposed to blue light. | Procedure or surgery | 5-ALA photopheresis |
| TransfusionThe treated cells are transferred back to the patient as a standard blood transfusion | Procedure or surgery | 5-ALA photopheresis |
| Continuous Mononuclear Cell Collection (CMNC)The mononuclear cells are collected using the Spectra Optia with the Continuous Mononuclear Cell Collection protocol. 90 ml of mononuclear cells will be collected and 100 ml of 0,9% saline will be added to dilute the cells before incubation with drug and photopheresis. | Procedure or surgery | 5-ALA photopheresis |
Primary outcome
Clinical response
Time frame: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and 3 months after last treatment
Clinical response (Harvey Bradshaw Index change > 3 from baseline or less than 4 points)
Safety and tolerability adverse events
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Frequency, seriousness and intensity of adverse events
Safety and tolerability Electrocardiogram-PR interval
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in PR interval before and after treatment
Safety and tolerability Electrocardiogram-PR segment
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in PR segment before and after treatment
Safety and tolerability Electrocardiogram-QT interval
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in QT interval before and after treatment
Safety and tolerability Electrocardiogram-ST segment
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in ST segment before and after treatment
Safety and tolerability Electrocardiogram-T wave
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in T wave before and after treatment
Safety and tolerability Electrocardiogram-QRS complex
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in QRS complex before and after treatment
Safety and tolerability vital signs
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Vital signs (heart rate) before and after treatment
Safety and tolerability blood pressure
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Vital signs (systolic and diastolic blood pressure) before and after treatment
Alkaline phosphatase
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in serum alkaline phosphatase (U/L) before and after treatment
Aspartate transferase
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in serum aspartate transferase(U/L) before and after treatment
Alanine aminotransferase
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in serum alanine aminotransferase (U/L) before and after treatment
Albumin
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Albumin (g/L) before and after treatment
Bilirubin
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Bilirubin (micromol/L) before and after treatment
Gamma glutamyltransferase
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum gamma glutamyltransferase (U/L) before and after treatment
White cell count
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood White cell count (10^9/L) before and after treatment
Neutrophil granulocytes
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood neutrophil granulocytes (10^9/L) before and after treatment
Lymphocytes
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Lymphocytes (10^9/L) before and after treatment
Monocytes
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Monocytes (10^9/L) before and after treatment
Eosinophile granulocytes
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Eosinophile granulocytes (10^9/L) before and after treatment
Basophile granulocytes
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Basophile granulocytes (10^9/L) before and after treatment
Platelet count
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Platelet count (10^9/L) before and after treatment
Mean Cell Volume
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Mean Cell Volume (fL) before and after treatment
Mean Cell hemoglobin
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Mean Cell hemoglobin (picogram) before and after treatment
International Normalized Ratio
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood International Normalized Ratio (0,8-1,2) before and after treatment
Hemoglobin
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Blood Hemoglobin (g/dL) before and after treatment
Calcium
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Calcium (millimol/L) before and after treatment
Potassium
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Potassium (millimol/L) before and after treatment
Sodium
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Sodium (millimol/L) before and after treatment
Creatinin
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Creatinine (micromol/L) before and after treatment
Lactate Dehydrogenase
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Lactate Dehydrogenase (U/L) before and after treatment
Cholesterol
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Cholesterol (millimol/L) before and after treatment
Total Protein
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Total Protein (g/L) before and after treatment
Carbamide
Time frame: Before every treatment visit (every second week from week 0-10, every 4th week from week 14-62, week 28 for patients not eligible for study extension and latter 5 patients) in addition to week 64 and 3 months after last treatment.
Changes in Serum Carbamide (millimol/L) before and after treatment
8 secondary outcomes
CD4+ and CD8+ T cell subpopulations
Time frame: Week 0, 10 (all patients) and 50 (patients of the first 5 subjects eligible for study extension)
Apoptosis and necrosis
Time frame: Week 0, 10 (all patients) and 50 (patients of the first 5 subjects eligible for study extension)
Clinical remission
Time frame: Week 13 and/or sustained/delayed response in week 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and 3 months after last treatment.
Endoscopic efficacy
Time frame: Week 13 (all patients) and 64 (patients of the first 5 subjects eligible for study extension) with baseline visit as reference.
Faecal calprotectin
Time frame: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Concentration of C reactive protein in blood
Time frame: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Quality of life questionnaire Short-Form 36 (SF-36)
Time frame: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Quality of life questionnaire Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and/or 3 months after last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 5-aminolevulinic acid, Blue light photopheresis and Transfusion in people with Crohn Disease, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. 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: finished, as of the sponsor's last update on 30 Jan 2024. 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 Norway. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: Week 13, 26 (28 for patients not eligible for study extension and the latter 5 patients), 38, 50, 64 and 3 months after last treatment). The study lists 35 primary outcomes in all. 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 30 Jan 2024.