CompletedPhase 2/3

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

Germany93 participantsStarted 2015-01-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Current diagnosis of a Moderate Aplastic Anemia requiring standard treatment with CSA without prior specific therapy.
✓. In this study need for treatment with CSA is defined as:

Exclusion criteria

✕. Age \< 18 years
✕. Severe or Very Severe Aplastic Anemia (hypocellularity of bone marrow 25 % and depression of two of the three peripheral counts: ANC \< 0.5 G/L, platelet count \< 20 G/L, reticulocyte count \< 20 G/L)
✕. Constitutional aplastic anemia (Fanconi anemia or Dyskeratosis congenita)
✕. Clonal myeloid disorders based on cytogenetic findings performed within 12 weeks of study entry. Especially, patients with cytogenetic abnormalities which are recurrent in MDS are not eligible for the study.
✕. Bone marrow reticulin fibrosis of grade 3 or greater
✕. Severe concurrent diseases precluding the patient's ability to tolerate protocol therapy
✕. ALT \> 3 times the upper limit of normal if this elevation is progressive, or persistent for 4 weeks, or accompanied by increased direct bilirubin, or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation
✕. Infection not adequately responding to appropriate therapy

What they're measuring

Trilineage hematologic response rate (CR + PR)

Timeframe: 6 months after treatment start

Trial details

NCT IDNCT02773225

SponsorB. Höchsmann

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Anemia, Aplastic trials