A Multicenter, Randomized, Double-blind, and Open-label, Placebo-controlled Phase II Clinical Study of Trappa Ethanolamine Tablets Combined With Ciclosporin in Patients With Treatment of Non-severe Aplastic Anemia

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country78 target enrollmentApril 26, 2023

ConditionsNon-severe Aplastic Anemia

InterventionsTrappa ethanolamine tablets ; ciclosporin Placebo ; ciclosporin

DrugsTrappa ethanolamine tablets ; ciclosporin Placebo ; ciclosporin

Overview

Phase: Phase 2
Intervention: Trappa ethanolamine tablets ; ciclosporin
Conditions: Non-severe Aplastic Anemia
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 78
Locations: 1
Primary Endpoint: Full hematological response rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 26, 2023

End Date

May 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Total blood cell loss and myelohypoproliferative diseases caused by other reasons
•Chromosome karyotype analysis during screening shows clonal cytogenetic abnormalities
•Meet the severe aplastic anemia
•Paroxysmal sleep hemoglobinuria (PNH) clone ≥50% or hemolytic PNH clone
•Randomly receive ATG, ciclosporin, TPO-R agonists, androgens and other drugs to treat the relapse without completing the elution
•Pre-randomized treatment with erythropoietin
•Pre-randomized use of corticosteroids, G-CSF and GM-CSF treatment
•People with a history of hematopoietic stem cell transplantation
•subjects who had deep vein thrombosis, myocardial infarction, cerebral infarction or peripheral arterial embolism in the first 12 months
•Previous history of liver cirrhosis or portal hypertension

Arms & Interventions

Trappa ethanolamine tablets combined with ciclosporin

Intervention: Trappa ethanolamine tablets ; ciclosporin

Placebo combined with ciclosporin

Intervention: Placebo ; ciclosporin

Outcomes

Primary Outcomes

Full hematological response rate

Time Frame: About 13 weeks from the first medication to the evaluation.

Secondary Outcomes

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)