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A prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochloride

A prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochloride

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011653
Enrollment
Unknown
Registered
2017-06-14
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic anemia

Interventions

SA group:none
LSA group:levamisole hydrochloride

Sponsors

The First affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All the patients meet a NSAA diagnostic criteria, and agree the immunosuppressive therapy. Diagnoses reference to The diagnostic and therapeutic criteria for hematologic diseases(Zhang Zhinan 2007), and The diagnosis and treatment of aplastic anemia (2016 UK guidelines); 2. 18-70years old, male or female; 3. liver and kidney function: the blood bilirubin is less than or equal to 2mg/dL (35 mol/L), AST/ALT in the upper limit of the normal value below 2 times, blood inosine is less than or equal to 177 umol/L; 4. heart function is normal: EF>50%; 5. no serious lung infection; 6. All cases had no history of cancer and chemotherapy history, immunology therapy.The control group without hematologic diseases, lupus or other immune disfunctions, allergic disease, Fanconi anemia; 7. consent signed by patients or their families.

Exclusion criteria

Exclusion criteria: 1. congenital hematopoietic failure, Fanconi anemia, or combined with bone marrow hyperplasia, leukemia, multiple myeloma, giant cell anemia, paroxysmal nocturnal hemoglobin or other blood diseases; 2. the HBV DNA copy number is greater than 1000/ml or the serum hepatitis B virus is not clear; 3. serum bilirubin > 2mg/dL (35 umol/L); ALT or AST > 2 times the normal value of the upper limit; alkaline phosphatase > 3 times the upper limit of the normal value; serum creatinine > 177 mol/L; 4. HIV positive; 5. other serious diseases that may limit the patient to participate in the study (e.g., the progressive infection, incontrollable diabetes, severe cardiac insufficiency or angina pectoris, etc.); 6. conditions are not suitable for immunosuppressive therapy; 7. pregnant or lactating women; 8. can not understand or follow the research program; 9. Patients under 16 years of age; 10. patients with a history of cancer, chemotherapy, or radiation therapy, immune system diseases or allergic diseases.

Design outcomes

Primary

MeasureTime frame
Routine blood test;Blood biochemistry;Cyclosporine concentration;Bone Marrow Examin;

Secondary

MeasureTime frame
electrocardiogram;echocardiography;

Countries

China

Contacts

Public ContactShengyun Lin

The First affiliated Hospital of Zhejiang Chinese Medical University

lsyww2003@163.com+86 13588887285

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026