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:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02150551
Eligibility Criteria:
Inclusion Criteria:
* For the young adult cohort, patients must be ages 17 ≤22 years
* For the pediatric cohort, patients must be ages 12 ≤16 years
* Patients must have moderate-severely active CD or UC (defined in section 2.3), and documented active disease on flexible sigmoidoscopy, colonoscopy or MR enterography within the preceding 2 months.
* Patients who have failed or are intolerant of biologic therapy. Specifically, the patient will have recurrence or persistence of active disease despite current or past treatment with a biologic. At the time of enrollment, study subjects may be currently receiving 5-aminosalicylates, corticosteroids (≤ 20 mg daily or up to 0.5 mg/kg/day if weight \<40 kg), methotrexate, 6MP/azathioprine, or a biologic (either as monotherapy or in combination). During the treatment phase, if the treating physician thinks that a medication dose should be lowered to avoid side effects, this should be recorded.
* Patient or parent/guardian capable of providing informed consent.
Exclusion Criteria:
* • Patients \< 12 years of age or \>22 years of age
* Pregnant or breastfeeding. Serum pregnancy test must be negative at screening for female subjects of childbearing potential. Urine pregnancy test must remain negative at each of 4 infusion visits.
* Patients with toxic mega-colon or intestinal perforation
* Evidence of autoimmune chronic active hepatitis or sclerosing cholangitis.
* Patients with fever \> 39° C or clinically significant active infection within 1 week (i.e. chronic infections including Hepatitis B/C or HIV or acute infections, including urinary tract infection and respiratory tract infection)
* Received an agent not approved by the FDA for marketed use in any indication or any small molecule inhibitors (i.e. naltrexone) within 60 days of enrollment.
* Subjects who are taking greater than 20 mg (or if body weight \<40 kg, 0.5 mg/kg) of prednisone daily.
* Clinically significant abnormal biochemical and hematological parameters, including:
* Neutrophil count \< 1000 cells/mm3
* Hemoglobin \< 8 g/dl
* Platelet count ≤ 130 cells/mm3
* Creatinine ≥ 1.2 x the upper limit of normal
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal
* Conjugated bilirubin greater than 1.2. mg/dL
* Has active infection with enteric pathogens as evidenced by positive microbiological culture of stool or C.difficile toxin PCR.
* Had bowel surgery other than perianal procedures (fistulotomy, seton placement, abscess drainage) within 3 months of enrollment.
* Has uveitis
* Has known pulmonary disease, excluding mild intermittent asthma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
22 Years
Study:
NCT02150551
Study Brief:
Protocol Section:
NCT02150551