Not Yet RecruitingPhase 2

CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA

43 participantsStarted 2026-04

Plain-language summary

This study aimed to explore the efficacy and safety of cyclosporine (CsA) +eltrombopag (EPAG)/hetrombopag (HPAG)+romiplostim N01 in the treatment of newly-diagnosed transfusion-dependent aplastic anemia (TD-NSAA) and severe aplastic anemia (SAA)

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years old;

Exclusion criteria

✕. Had no HLA-matched donors or was not suitable for first-line allogeneic hematopoietic stem cell transplantation (HSCT);
✕. Not suitable for ATG, due to reasons such as age, complications, and the patient's own wishes;
✕. With baseline liver and kidney functions \<2 ULN;
✕. ECOG score ≤ 2;
✕. Signed the informed consent;
✕. Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc.;
✕. With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics;
✕. PNH clone ≥ 50%;

What they're measuring

Overall response rate (ORR)

Timeframe: 6-month

Trial details

NCT IDNCT07558434

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Bing Han

+86 13601059938 hanbing_li@sina.com.cn

View on ClinicalTrials.gov More Severe Aplastic Anemia (SAA) trials