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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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16 December 2017 |
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Main ID: |
NCT02426372 |
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Date of registration:
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21/04/2015 |
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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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Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis
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Scientific title:
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An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02426372 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Qu Biologics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects who have reached age of majority
- Willing to learn and able to self-administer study drug
- Diagnosis of UC established at least 6 months before screening visit, by clinical and
endoscopic evidence.
- Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12
(inclusive) at Screening.
- Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy,
with an Endoscopic Finding Sub-score of =2 at Screening.
- Rectal Bleeding Sub-score of =1 at Screening.
- Physician's Global Assessment Sub-score of =2 at Screening.
- Male/female subjects who agree to practice effective methods of contraception
Exclusion Criteria:
- History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
- Currently receiving total parenteral nutrition
- Disease limited to ulcerative proctitis
- Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or,
ischemic or infectious colitis
- Known or suspected hypersensitivity to any component of the product
- Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
- Concurrently participating in another study or receiving other experimental or
investigational therapies within past 3 months
- Females who are currently pregnant or lactating
- Any history of malignancy. Exceptions may apply for cervical cancer and some forms of
skin cancer
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Biological: QBECO SSI
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Primary Outcome(s)
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Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)
[Time Frame: Day 1 to Week 56]
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Proportion of subjects in clinical remission
[Time Frame: Week 52]
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Secondary Outcome(s)
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Proportion of subjects with a clinical response
[Time Frame: Week 16]
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Proportion of subjects in clinical remission
[Time Frame: Week 16]
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Proportion of subjects with a clinical response
[Time Frame: Week 52]
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Secondary ID(s)
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QBECO-UC-01
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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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