NCT05797623RecruitingPhase 2
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 enrollmentStarted: April 26, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Full hematological response rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Trappa ethanolamine tablets combined with ciclosporin
Experimental
Intervention: Trappa ethanolamine tablets ; ciclosporin (Drug)
Placebo combined with ciclosporin
Placebo Comparator
Intervention: Placebo ; ciclosporin (Drug)
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)
Investigators
Study Sites (1)
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