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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01044667
Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness to provide written informed consent and adhere to study regimen
* Recipients who are 18-70 years of age
* Patients who have undergone either single or double lung transplant are discharged on the standard MMF (no generic MMF will be used) therapy and complain of GI symptoms, thought to be related to their immunosuppressive regimen
Exclusion Criteria:
* Patients who have GI complaints thought to be due to factors other than immunosuppressive regimen
* Patients receiving steroid treatment for acute rejection
* Women of childbearing potential who do not agree to use at least two acceptable forms of contraception prior to starting study drug, while taking study drug, and for 6 weeks after stopping study drug
* Women who have a positive serum or urine pregnancy test at visit 1 and/or continuing through the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01044667
Study Brief:
Protocol Section:
NCT01044667