Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

January 27, 2015

Primary Completion Date

January 30, 2025

Study Completion Date

January 30, 2025

Conditions
Anemia, Aplastic
Interventions
DRUG

Eltrombopag

"* CSA + Eltrombopag, evaluation after three month therapy start regarding dose escalation~* 6 month after therapy start --\> evaluation and report of remission status of the study office --\> unblinding by study office --\> partial or complete remission Eltrombopag and slow tapering of CSA~* 12 month after therapy start --\> evaluation and report of remission status --\> complete and partial remission --\> tapering/end of study treatment"

DRUG

Placebo (for Eltrombopag)

"* CSA + Placebo, evaluation after three month therapy start regarding dose escalation~* 6 month after therapy start --\> evaluation and report of remission status of the study office --\> unblinding by study office --\> no complete remission: CSA + Eltrombopag and evaluation 3 months after therapy start --\> dose escalation~* 12 month after start of eltrombopag --\> evaluation and report of remission status --\> complete and partial remission --\> tapering/end of study treatment"

Trial Locations (1)

89081

University Hospital Ulm, Ulm

All Listed Sponsors
lead

B. Höchsmann

OTHER

NCT02773225 - Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA) | Biotech Hunter | Biotech Hunter