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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT04970004
Eligibility Criteria:
Inclusion Criteria:
* Body weight ≥ 5 kg at the time of HSCT-TMA diagnosis
* Documented TMA diagnosis within 6 months from the HSCT
* Evidence of renal dysfunction
* Presence of hypertension
Exclusion Criteria:
* History or presence of familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity \< 5%)
* Shiga toxin-related hemolytic uremic syndrome (ST-HUS)
* Positive direct Coombs test
* Diagnosis of disseminated intravascular coagulation
* History or presence of bone marrow/graft failure
* Diagnosis of veno-occlusive disease
* Received a complement inhibitor (eg, eculizumab) post-HSCT through 12 months post TMA diagnosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT04970004
Study Brief:
Protocol Section:
NCT04970004