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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
NCT04112212 |
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Date of registration:
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25/09/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Using Vedolizumab-800CW to Gain Insight Into Local Drug Distribution and Mucosal Target Cells in IBD Patients
VISION |
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Scientific title:
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Using Fluorescently Labeled Vedolizumab to Visualize Local Drug Distribution During Colonoscopy and Identify Mucosal Target Cells in Patients With Inflammatory Bowel Disease |
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Date of first enrolment:
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November 4, 2020 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04112212 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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W.B. Nagengast, MD, PhD, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Center Groningen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Established diagnosis of IBD, or Ulcerative Colitis (UC) or Crohn's Disease (CD).
- Vedolizumab naïve and eligible for vedolizumab treatment.
- Age: 18 years or older.
- Written informed consent.
Exclusion Criteria:
- Prior vedolizumab treatment
- Vedolizumab contraindicated as therapy
- Pregnancy or breast feeding.
- Patients younger than 18 years old
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colitis, Ulcerative
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Crohn Disease
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Intervention(s)
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Drug: Fluorescence molecular imaging procedure using vedolizumab-800CW
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Other: Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW
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Combination Product: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab
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Primary Outcome(s)
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Fluorescent signal in patients with IBD
[Time Frame: After 18 months when study is completed.]
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Secondary Outcome(s)
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FMI ex vivo analysis to detect target cells
[Time Frame: After 18 months when study is completed.]
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Distribution of Vedolizumab in the inflamed gut
[Time Frame: After 18 months when study is completed.]
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Safety of Vedolizumab-800CW in patients with IBD
[Time Frame: Interim analysis after 30 weeks (at least 5 patients included). Complete data of all patients when study is completed. Individual patients were followed up for 1 week after vedolizumab-800CW injection for AE's, SAE's and SUSAR's.]
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Semi-quantifying fluorescent signals in patients with IBD
[Time Frame: Interim analysis after 30 weeks (at least 5 patients included). Complete data after 18 months when study is completed.]
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Secondary ID(s)
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NL69572.042.19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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