Immune-Mediated Thrombotic Thrombocytopenic Purpura, Thrombotic microangiopathy
Conditions
Brief summary
Treatment emergent adverse events
Detailed description
Time to clinical response, Change in platelet count from baseline, Time to recovery of platelets to ≥150×10E9/L, Change of organ damage markers from baseline, Time to recovery of LDH to ≤2 × ULN, Assessment or improvement (improvement of ≥1 grade in CTCAE v5.0 scale) of disease-related signs and symptoms within 90 days post intervention (by number of unique participants and by total number of AEs), Number of days in the intensive care unit and the number of days hospitalized, All-cause and disease-specific mortality within 90 days post-intervention, Plasma concentrations of TGD001, PK parameters such as Cmax, Tmax, AUC, t1/2, Development of ADA
Interventions
None listed
Sponsors
TargED Biopharmaceuticals B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to clinical response, Change in platelet count from baseline, Time to recovery of platelets to ≥150×10E9/L, Change of organ damage markers from baseline, Time to recovery of LDH to ≤2 × ULN, Assessment or improvement (improvement of ≥1 grade in CTCAE v5.0 scale) of disease-related signs and symptoms within 90 days post intervention (by number of unique participants and by total number of AEs), Number of days in the intensive care unit and the number of days hospitalized, All-cause and disease-specific mortality within 90 days post-intervention, Plasma concentrations of TGD001, PK parameters such as Cmax, Tmax, AUC, t1/2, Development of ADA | — |
Outcome results
None listed