Not Yet RecruitingPhase 3

Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA

90 participantsStarted 2026-04

Plain-language summary

This study aimed to compare the efficacy and safety of enarodustat combined with cyclosporine versus cyclosporine monotherapy in the treatment of newly-diagnosed tansfusion-dependent non-severe aplastic anemia (TD-NSAA).

Who can participate

Age range18 Years

SexALL

See this in plain English?

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);
✕. 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%;
✕. Received HSCT before enrollment;

What they're measuring

ORR

Timeframe: 6-month

Trial details

NCT IDNCT07548671

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 Transfusion-dependent Non-severe Aplastic Anemia trials