EUCTR2017-003284-35-HU
Active, not recruiting
Phase 1
A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate to severe Ulcerative Colitis.
- Sponsor
- ABIVAX
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject will be eligible for inclusion in this study only if ALL of the
- •following criteria apply:
- •? Subjects previously enrolled in the ABX464\-101 clinical study who have
- •completed the initial 2\-month treatment phase;
- •? Subjects able and willing to comply with study visits and procedures;
- •? Subjects with hematological and biochemical laboratory parameters as
- •follows at the D56 visit of the ABX464\-101 study:
- •o Hemoglobin \> 9\.0 g dL\-1;
- •o Absolute neutrophil count \= 750 mm\-3;
- •o Platelets \= 100,000 mm\-3;
Exclusion Criteria
- •The following criterion should be checked at the time of screening. If
- •this exclusion criterion applies, the subject will not be included in the
- •? Any condition, which in the opinion of the investigator, could
- •compromise the subject's safety or the adherence to the study protocol.
Outcomes
Primary Outcomes
Not specified
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