Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03218657
• Date of registration: 16/06/2017
• Prospective Registration: Yes
• Primary sponsor: Shengyun Lin
• Public title: Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole
• Scientific title: A Prospective, Randomized, Controlled Clinical Study of Non Transfusion Dependent Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole Hydrochloride
• Date of first enrolment: January 1, 2018
• Target sample size: 248
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03218657
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Lin S Yun, master

• Name: Lin s Yun, master

Key inclusion & exclusion 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:

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Aplastic Anemia

Intervention(s)

Drug: Cyclosporins

Drug: Androgens

Drug: levamisole hydrochloride

Primary Outcome(s)

Routine blood test [Time Frame: up to 4 weeks]

Secondary Outcome(s)

biochemical test [Time Frame: up to 4 weeks]

Bone marrow [Time Frame: 1 year]

Secondary ID(s)

AA-LSA/SA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors