Conditions: Purpura, Thrombocytopenic, Idiopathic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.

Detailed description:

Arms:
arm 1: The patients were administered 120 mg BI 655064 solution for subcutaneous injection q1w (once a week) subcutaneously for 4 weeks.

Patients who showed an increase in platelet count above or equal to 100 x 10\^9/L continued treatment with 120 mg BI 655064 solution for subcutaneous injection q1w for additional 8 weeks, followed by 12 weeks of follow-up.

Patients whose platelet count stayed below 100 x 10\^9/L continued treatment for 2 weeks with 180 mg BI 655064 solution for subcutaneous injection q1w followed by 120 mg BI 655064 solution for subcutaneous injection q1w for additional 6 weeks, followed by 12 weeks of follow-up.

Interventions: intervention 1: BI 655064
Intervention descriptions: intervention 1: subcutaneous injection

Protocol document: