Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia

Last updated: August 31, 2023
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Anemia

Treatment

Trappa ethanolamine tablets ; ciclosporin

Placebo ; ciclosporin

Clinical Study ID

NCT05797623
SHR8735-201
  • Ages 14-75
  • All Genders

Study Summary

This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 14-75 years old (including boundary value, whichever is at the time of signing theinformed consent form), Gender is not limited.
  2. Diagnosed with non-heavy aplastic anemia within 6 months
  3. Life Functional Status (ECOG) Score 0-1
  4. Those who understand the research procedures and methods, voluntarily participate inthis experiment, and sign the informed consent form in writing

Exclusion

Exclusion Criteria:

  1. Total blood cell loss and myelohypoproliferative diseases caused by other reasons
  2. Chromosome karyotype analysis during screening shows clonal cytogenetic abnormalities
  3. Meet the severe aplastic anemia
  4. Paroxysmal sleep hemoglobinuria (PNH) clone ≥50% or hemolytic PNH clone
  5. Randomly receive ATG, ciclosporin, TPO-R agonists, androgens and other drugs to treatthe relapse without completing the elution
  6. Pre-randomized treatment with erythropoietin
  7. Pre-randomized use of corticosteroids, G-CSF and GM-CSF treatment
  8. People with a history of hematopoietic stem cell transplantation
  9. subjects who had deep vein thrombosis, myocardial infarction, cerebral infarction orperipheral arterial embolism in the first 12 months
  10. Previous history of liver cirrhosis or portal hypertension
  11. When screening, alanine aminotransferase, barley transaminase, total bilirubin andblood creatinine are higher than the upper limit of normal value
  12. HIV infection or carrier in the past or screening; hepatitis C antibody positive;hepatitis B surface antigen positive or hepatitis B core antibody positive, andHBV-DNA test indicates virus replication
  13. Patients with randomized bleeding and/or infection that are still uncontrollable afterstandardized treatment
  14. Uncontrolled hypertension at screening, severe arrhythmia, level III/IV (graded by theNew York Heart Association) congestive heart failure
  15. Those who are known or suspected to be contraindicated or highly sensitive to Trappaethanolamine API or cyclosporine
  16. The subjects had any malignant solid tumors of the organ system in the first 5 yearsof screening, regardless of whether they had been treated, metastasis or relapsed,except for local skin basal cell carcinoma; subjects with blood tumors found in thepast or screening
  17. Pregnant or lactating women
  18. Male subjects of women of childbearing age or partners of women of childbearing agerefuse to use acceptable contraceptive measures from the period of taking the drug to 28 days after the last time of taking the drug.
  19. Randomly participated in other clinical trials and took research drugs in the first 3months.
  20. The researchers believe that there is any situation that may cause the subject to beunable to complete the study or pose an obvious risk to the subject, or other factorsthat reduce the possibility of joining the group.

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Trappa ethanolamine tablets ; ciclosporin
Phase: 2
Study Start date:
April 26, 2023
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • Hematology Hospital of Chinese Academy of Medical Sciences

    Tianjin, Tianjin 30000
    China

    Active - Recruiting

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