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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01925950
Eligibility Criteria:
Inclusion Criteria:
* Receipt of allogeneic hematopoietic cell transplant \>100 days prior to consent
* Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
* Endoscopic findings consistent with GI GVHD
* Must be able to swallow tablets
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study
Exclusion Criteria:
* \>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
* GI infection
* Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* HIV seropositivity
* Pregnant or nursing female
* Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
* Evidence of recurrent or progressing malignant disorder that was the indication for HCT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01925950
Study Brief:
Protocol Section:
NCT01925950