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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01647412
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent
* Age 10-17 years
* Diagnosis of CD as determined by standard clinical, radiological, and pathological criteria
* Clinical evidence of CD for more than 2 years
* Moderate to severely active CD, as defined by a PCDAI score \> 30 and \< 65
* May continue use of aminosalicylates, antibiotics, immunomodulators, including azathioprine, 6-mercaptopurine and methotrexate, as well as the monoclonal antibody drug, infliximab, if prescribed for at least 4 months and receiving stable doses for at least 2 months prior to baseline visit
* May continue the use of prednisone if prescribed for at least 6 weeks prior to baseline visit
* Meets the following hematological and biochemical requirements:
* HGB \> 8.5 g/dl
* WBC \> 3.5 x 109/L
* Neut. \> 1.5 x 109
* Plats \> 100 x 109/L
* SGOT \& Alk Phos not \> 2 times the upper limit of normal
Exclusion Criteria:
* Acute critical illness
* Acute, chronic, or latent infection
* Active neoplasia and/or history of neoplastic disease of any origin other than basal cell carcinoma that has been removed
* Evidence of a systemic disorder unrelated to CD involving hepatic, gastrointestinal, pulmonary, cardiac, renal, hematologic, endocrine, central or peripheral nervous systems
* Use of parenteral corticosteroids or corticotrophin within 2 months of baseline visit
* Use of another investigational agent within 3 months of baseline visit
* Long-term anti-coagulant therapy or use of any anti-coagulant medication, including NSAIDs or ASA, within 2 weeks of screening visit
* Pregnancy (positive pregnancy test)
* Positive stool culture for enteric pathogens, pathogenic ova, parasites or clostridium difficile toxin
* Any condition that the investigator believes would pose significant harm to the subject if the investigational therapy were initiated
* Diagnosis of short bowel syndrome and also on TPN
* Presence of an ostomy, symptomatic stenosis or ileal stricture, or severe intestinal stricture, proctocolectomy, total colectomy or stoma
* Patients in imminent need of surgery due to active gastrointestinal bleeding fixed stenosis, intermittent obstruction or obstructive event within 2 months prior to screening.
* Patients who underwent CD surgery within 2 months of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT01647412
Study Brief:
Protocol Section:
NCT01647412