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

Phase 2

Recruiting

• Conditions: Non-severe Aplastic Anemia
• Interventions: Drug: Placebo ; ciclosporin; Drug: Trappa ethanolamine tablets ; ciclosporin

• Registration Number: NCT05797623
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-04
• Study Start: 2023-04-26
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. 14-75 years old (including boundary value, whichever is at the time of signing the informed 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 in this experiment, and sign the informed consent form in writing

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 treat the 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 or peripheral 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 and blood 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, and HBV-DNA test indicates virus replication
13. Patients with randomized bleeding and/or infection that are still uncontrollable after standardized treatment
14. Uncontrolled hypertension at screening, severe arrhythmia, level III/IV (graded by the New York Heart Association) congestive heart failure
15. Those who are known or suspected to be contraindicated or highly sensitive to Trappa ethanolamine API or cyclosporine
16. The subjects had any malignant solid tumors of the organ system in the first 5 years of screening, regardless of whether they had been treated, metastasis or relapsed, except for local skin basal cell carcinoma; subjects with blood tumors found in the past or screening
17. Pregnant or lactating women
18. Male subjects of women of childbearing age or partners of women of childbearing age refuse 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 3 months.
20. The researchers believe that there is any situation that may cause the subject to be unable to complete the study or pose an obvious risk to the subject, or other factors that reduce the possibility of joining the group.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo combined with ciclosporin	Placebo ; ciclosporin	-
Trappa ethanolamine tablets combined with ciclosporin	Trappa ethanolamine tablets ; ciclosporin	-

Primary Outcome Measures

Name	Time	Method
Full hematological response rate	About 13 weeks from the first medication to the evaluation.

Secondary Outcome Measures

Name	Time	Method
The time required for the first hematological response	About 26 weeks from the first medication to the evaluation
Changes in platelet count relative to the baseline of each visiting point of view	About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients with disease progression	About 26 weeks from the first medication to the evaluation
Cumulative total amount of platelet transfusions	About 26 weeks from the first medication to the evaluation
Changes in hemoglobin relative to the baseline of each visiting point of view	About 26 weeks from the first medication to the evaluation
Changes in absolute neutrophil count relative to the baseline of each visiting point of view	About 26 weeks from the first medication to the evaluation
Partial hematological response rate and total hematological response rate	About 13 weeks from the first medication to the evaluation
Hematological response rate	About 26 weeks from the first medication to the evaluation
Cumulative amount of red blood cell infusions	About 26 weeks from the first medication to the evaluation
Changes in reticulocyte count relative to the baseline of each visiting point of view	About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients who need blood transfusion	About 26 weeks from the first medication to the evaluation

Trial Locations

Locations (1)

Hematology Hospital of Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China