Primary immune thrombocytopenia
Conditions
Brief summary
Log2 (platelet count) at Week 12 (6 mg cohort), and at Week 16 for both 18 mg and 50 mg cohorts.
Detailed description
Modified overall response (mOR) at Week 12 (6 mg cohort), and at Week 16 for both 18 mg and 50 mg cohorts., Complete response (CR) at Week 12 (6 mg cohort), and at Week 16 for both 18 mg and 50 mg cohorts., Incidence of AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study intervention, Day 1 through end of study, Log2 (platelet count), Modified response (mOR), Complete response (CR), Absolute values and change of platelet count from baseline, Absolute values and change from baseline of circulating B and cTfh cell counts
Interventions
DRUGPF-06835375 Injection
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Log2 (platelet count) at Week 12 (6 mg cohort), and at Week 16 for both 18 mg and 50 mg cohorts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified overall response (mOR) at Week 12 (6 mg cohort), and at Week 16 for both 18 mg and 50 mg cohorts., Complete response (CR) at Week 12 (6 mg cohort), and at Week 16 for both 18 mg and 50 mg cohorts., Incidence of AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study intervention, Day 1 through end of study, Log2 (platelet count), Modified response (mOR), Complete response (CR), Absolute values and change of platelet count from baseline, Absolute values and change from baseline of circulating B and cTfh cell counts | — |
Countries
Czechia, Hungary, Poland
Outcome results
None listed