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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00798967
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent prior to any study-related procedures are performed
* Men and women 18 years of age or older at the time of informed consent signing
* Intestinal failure resulting in Short Bowel Syndrome
* At least 12 months of continuous PN dependency
* 12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
* PN required at least 3 times weekly
* A stable PN volume for four weeks prior to dosing
Exclusion Criteria:
* History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
* Participation in clinical study within 30 days for drug or 90 days for antibody
* Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
* Use of iv glutamine within 30 days prior to screening
* Use of teduglutide
* CD patients who have been treated with biological therapy within 6 months of screening
* IBD patients who require chronic systemic immunosuppressant therapy
* More than 4 SBS- or PN-related hospitalizations within 12 months of screening
* Unplanned hospitalization within one month of screening
* Pregnant or lactating women
* Body weight \> 88kg
* Body mass index (BMI) \< 15 kg/m2
* Severe hepatic impairment or disturbed renal function
* Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period
* Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
* Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results
* Significant active, uncontrolled, untreated systemic diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00798967
Study Brief:
Protocol Section:
NCT00798967