A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Cyclosporine Combined With Avatrombopag in the Treatment of Non-severe Aplastic Anemia in the Elderly

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

For elderly patients who cannot tolerate anti-thymocyte globulin (ATG) treatment, the addition of avatrombopag (AVA), which has a slight adverse reaction, can theoretically improve the hematological response rate in elderly patients with non-severe aplastic anemia (NSAA) without significantly increasing adverse reactions. Based on this, this study treated NSAA patients older than 60 with AVA combined with CsA to evaluate the hematological response rate and safety of AVA in the elderly who could not tolerate ATG therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• Elderly patients with well-defined NSAA anemia who meet the diagnostic criteria for aplastic anemia (AA) but do not meet the diagnostic criteria for severe aplastic anemia (SAA).

• Age 60 years or older, male or female.

• Able to swallow or administer orally.

• Intolerant or refused anti-thymocyte globulin treatment

⁃ 6\. No previous treatment with cyclosporine, tacrolimus or hormones or treatment for less than 1 month.

⁃ 7\. No prior treatment with thrombopoietin (TPO) receptor agonists (including eltrombopag, herombopag, romiplostim, etc.) 8. Informed consent must be signed before the start of all specific research procedures. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent shall be signed by the patient's immediate family.

Locations
Other Locations
China
Peking union medical college hospital
RECRUITING
Beijing
Contact Information
Primary
Bing Han
hanbing_li@sina.com
+861069151235
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2025-08
Participants
Target number of participants: 30
Treatments
Experimental: treatment group
Cyclosporine: 3mg/kg/d 3-5mg/kg bid was administered to maintain the trough concentration at 100-200 μg/ml;~Avatrombopag: The dosage was 40\~60mg orally, once a day, and the dosage was adjusted according to the subject's platelet count. The drug was administered for 24 weeks (6 months).
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov