Combining Trappa Ethanolamine Tablets with Ciclosporin for Non-severe Aplastic Anemia

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

This study is testing if adding trappa ethanolamine tablets to ciclosporin can help people aged 14 to 75 with non-severe aplastic anemia feel better and stay safe.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05797623 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, and open-label clinical study aims to evaluate the safety and effectiveness of trappa ethanolamine tablets when combined with ciclosporin in treating patients diagnosed with non-severe aplastic anemia. Participants will be randomly assigned to receive either the treatment or a placebo alongside ciclosporin. The study will include individuals aged 14 to 75 who have been diagnosed within the last six months and have a life functional status score of 0-1. The trial will assess both the therapeutic effects and safety profile of the combined treatment approach.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14-75 diagnosed with non-severe aplastic anemia within the last six months.

Not a fit: Patients with severe aplastic anemia or those with certain hematological disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with non-severe aplastic anemia.

How similar studies have performed: While this approach is novel, similar studies have shown promise in combining treatments for hematological conditions.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin

• Hematology Hospital of Chinese Academy of Medical Sciences — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Wanyi Zhai

Conditions Non-severe Aplastic Anemia