Last updated: June 22, 2022
Sponsor: Institute of Hematology & Blood Diseases Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Anemia
Aplastic Anemia
Treatment
N/AClinical Study ID
NCT05433922
fkzhang
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- elderly patients with V/SAA with a definite diagnosis.
- age greater than 60 years, male or female.
- Subjects must complete all screening assessments as outlined in the trial protocol.
- Able to swallow or administer the drug orally.
- Cannot tolerate or refuse ATG therapy.
- No prior treatment with cyclosporine, tacrolimus or hormones or treatment for no morethan 2 weeks.
- No prior application of TPO receptor agonists (including Thrombopoietin, Eltrombopag,Hetrombopag, etc.) or application of TPO receptor agonists for treatment with ≤ 5total doses and ≤ 7 days of TPO receptor agonist drugs such as Eltrombopag,Hetrombopag, etc.
- Informed consent must be signed prior to the start of all specific study procedures,in consideration of the patient's condition, or by a member of the patient's immediatefamily if the patient's signature is not conducive to the treatment of the condition.
Exclusion
Exclusion Criteria: No subject shall be enrolled in this study if he/she meets any of the following criteria.
- known diagnosis of congenital hematopoietic failure disorders (e.g. Fanconi anemia)and other causes of allogeneic cytopenias and bone marrow hypoproliferative disorders (e.g. hemolytic PNH, hypoproliferative MDS/AML, autoantibody-mediated allogeneiccytopenias, etc.);
- Patients with uncontrolled bleeding and/or infection despite standard treatment.
- patients with previous history of hematopoietic stem cell transplantation;
- previous history of thrombosis.
- Patients with concurrent malignancy or potential cancer on immunosuppressive therapy.
- Those who are considered unsuitable for enrollment by the investigator.
Study Design
Total Participants: 80
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin 300020
ChinaActive - Recruiting
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