Enarodustat + CsA vs CsA in Newly Diagnosed TD-NSAA
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 18 years old;
Diagnosed with aplastic anemia (AA) through routine blood tests, bone marrow puncture, bone marrow biopsy, and exclusion tests, and determined as transfusion-dependent non-severe aplastic anemia (TD NSAA) according to the Camitta criteria; Hemoglobin<90g/L;
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Enarodustat
- Cyclosporine (CsA)
Treatment groups
90 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov