Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy
Conditions
Brief summary
100-day survival rate from date of HSCT-TMA diagnosis
Detailed description
Survival at 52 weeks and median, mean, and overall survival from date of TMA diagnosis, Narsoplimab peak and trough PK and concomitant lectin pathway activation measured by ex vivo assay, Safety will be evaluated by adverse events and laboratory measures., Anti-drug antibody response, Responder rate based on clinical response criteria
Interventions
None listed
Sponsors
Omeros Corp.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 100-day survival rate from date of HSCT-TMA diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival at 52 weeks and median, mean, and overall survival from date of TMA diagnosis, Narsoplimab peak and trough PK and concomitant lectin pathway activation measured by ex vivo assay, Safety will be evaluated by adverse events and laboratory measures., Anti-drug antibody response, Responder rate based on clinical response criteria | — |
Countries
Germany, Netherlands, Spain
Outcome results
None listed