Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT03720002
Eligibility Criteria:
Inclusion criteria:
* Established diagnosis of UC
* Age- 18-70
* active UC defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≥5 and a score of ≥2 in the modified Mayo endoscopic sub-score.
* Stable medication dose or if the patient has discontinued previous treatment :
for Infliximab or Vedolizumab - at least one month after patient received last dose; for Adalimumab, Golimumab, immunomodulator, corticosteroids, 5ASA - at least two weeks after patient received last dose.
Exclusion criteria:
* non-controlled renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, uncontrolled migraines or neurological disorders
* significant laboratory abnormalities, including anemia with hemoglobin \<10, leucopenia , thrombocytopenia , abnormal coagulation tests , or elevation of liver or kidney function tests above the normal values.
* active infection, sepsis or pneumonia.
* pregnancy/nursing
* known allergy to the compound
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03720002
Study Brief:
Protocol Section:
NCT03720002