Safety and Effectiveness of Trappa Ethanolamine Tablets Combined With Ciclosporin in the Treatment of Primary Treatment of Non-severe Aplastic Anemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Trappa ethanolamine tablets combined with ciclosporin
|
Drug: Trappa ethanolamine tablets ; ciclosporin
Trappa ethanolamine tablets combined with ciclosporin
|
| Placebo Comparator: Placebo combined with ciclosporin
|
Drug: Placebo ; ciclosporin
Placebo combined with ciclosporin
|
Outcome Measures
Primary Outcome Measures
- Full hematological response rate [About 13 weeks from the first medication to the evaluation.]
Secondary Outcome Measures
- 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]
- 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]
- 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]
- 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]
- Cumulative total amount of platelet transfusions [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]
- Cumulative proportion of patients with disease progression [About 26 weeks from the first medication to the evaluation]
Eligibility Criteria
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
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Pre-randomized use of corticosteroids, G-CSF and GM-CSF treatment
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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.
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Randomly participated in other clinical trials and took research drugs in the first 3 months.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR8735-201