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

NCT02773225 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-06-10

No results posted yet for this study

Summary

The aim of this study is to improve treatment of Moderate Aplastic Anemia (MAA) by evaluating the safety and efficiency of Eltrombopag as a new treatment option in patients with therapy requiring MAA.

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

Sponsors & Collaborators

  • B. Höchsmann

    lead OTHER

Principal Investigators

  • Britta Höchsmann, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-27
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02773225 on ClinicalTrials.gov