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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT01999361
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients age 18-70 years of age.
2. Ability to provide written informed consent.
3. Mentally stable and able to comply with the procedures of the study protocol.
4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
5. History of at least one islet transplant.
6. Stimulated C-peptide \<0.3 ng/ml.
Exclusion Criteria:
1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
2. For female participants: Positive pregnancy test or presently breast-feeding.
3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
5. Known active alcohol or substance abuse.
6. Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction \<30%.
7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient.
8. Evidence of inter-current infection.
9. Active peptic ulcer disease
10. History on non-adherence to prescribed regimens including immunosuppression.
11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01999361
Study Brief:
Protocol Section:
NCT01999361