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Hetrombopag + Ciclosporin in Non-severe Aplastic Anemia
NCT05797623Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2023
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Hengrui
- Modality
- Small Molecules
- Drugs
- hetrombopag
- Conditions
- aplastic anemia
01
Overview
Phase 2, randomised, double-blind trial in aplastic anemia comparing Hetrombopag + Ciclosporin with Placebo + Ciclosporin (2 arms). Primary endpoint: Full hematological response rate at 13 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hetrombopag + Ciclosporin
Trappa ethanolamine (Hetrombopag) combined with Ciclosporin
Placebo + Ciclosporin
Placebo combined with Ciclosporin
03
Endpoints
Primary
Full hematological response rate
Secondary
Partial hematological response rate and total hematological response rate
Hematological response rate
The time required for the first hematological response
Changes in platelet count relative to the baseline
Changes in hemoglobin relative to the baseline
Changes in absolute neutrophil count relative to the baseline
Changes in reticulocyte count relative to the baseline
Cumulative proportion of patients who need blood transfusion
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