Chronic Immune Thrombocytopenia (ITP)
Conditions
Brief summary
The rate of subjects with response (R), defined as subjects with a platelet count > 30 × 109/L and at least a 2-fold increase of the baseline count, confirmed during the evaluation period on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period.
Detailed description
1.Number and rate of subjects with: a.CR: PLT > 100x109/L on 2 occasions at least 7 days apart and no bleeding b. loss of CR or R: PLT <100x109/L or bleeding ( CR) or PLT <30x109/L or < 2-fold increase of baseline or bleeding (R) c.Non-responders (NR), 2.Time to response, 3. Response Duration, 4. Hemorrhages regression of, 5. maximum PLT count achieved, 6.Time to maximum PLT count, 7.Bleedings (timing/grade)
Interventions
DRUGKIg10
Sponsors
Kedrion S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of subjects with response (R), defined as subjects with a platelet count > 30 × 109/L and at least a 2-fold increase of the baseline count, confirmed during the evaluation period on at least 2 separate occasions at least 7 days apart, and absence of bleeding during the evaluation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number and rate of subjects with: a.CR: PLT > 100x109/L on 2 occasions at least 7 days apart and no bleeding b. loss of CR or R: PLT <100x109/L or bleeding ( CR) or PLT <30x109/L or < 2-fold increase of baseline or bleeding (R) c.Non-responders (NR), 2.Time to response, 3. Response Duration, 4. Hemorrhages regression of, 5. maximum PLT count achieved, 6.Time to maximum PLT count, 7.Bleedings (timing/grade) | — |
Countries
Czechia, Germany, Italy, Romania, Spain
Outcome results
None listed