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

Hengrui Medicine

Status and phase

Enrolling

Phase 2

Conditions

Non-severe Aplastic Anemia

Treatments

Drug: Placebo ; ciclosporin

Drug: Trappa ethanolamine tablets ; ciclosporin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05797623

SHR8735-201

Details and patient eligibility

About

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.

Enrollment

78 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

No Healthy Volunteers

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
When screening, alanine aminotransferase, barley transaminase, total bilirubin and blood creatinine are higher than the upper limit of normal value
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
Patients with randomized bleeding and/or infection that are still uncontrollable after standardized treatment
Uncontrolled hypertension at screening, severe arrhythmia, level III/IV (graded by the New York Heart Association) congestive heart failure
Those who are known or suspected to be contraindicated or highly sensitive to Trappa ethanolamine API or cyclosporine
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
Pregnant or lactating women
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.
Randomly participated in other clinical trials and took research drugs in the first 3 months.
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.