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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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12 December 2020 |
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Main ID: |
NCT03860896 |
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Date of registration:
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14/02/2019 |
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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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GB004 in Adult Subjects With Active Ulcerative Colitis
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Scientific title:
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A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis |
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Date of first enrolment:
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April 24, 2019 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03860896 |
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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: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Georgia
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Moldova, Republic of
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo
Score assessment, and evidence of colonic inflammation.
Exclusion Criteria:
- Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or
parasitic infection.
- Patients receiving biologic agents and experimental agents are excluded.
Age minimum:
18 Years
Age maximum:
74 Years
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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Drug: Placebo
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Drug: GB004
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Primary Outcome(s)
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Incidence of treatment emergent adverse events
[Time Frame: 56 Days]
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Secondary Outcome(s)
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Pharmacokinetics: Maximum Concentration (Cmax) of GB004
[Time Frame: Day 1 to Day 28]
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Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
[Time Frame: Day 1 to Day 28]
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Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
[Time Frame: Day 1 to Day 28]
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Secondary ID(s)
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GB004-1101
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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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