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Trial record 24 of 1543 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT03218657
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Shengyun Lin, Zhejiang Provincial Hospital of TCM

Brief Summary:
The clinical symptoms of non transfusion dependent non severe aplastic anemia (NSAA) are often lighter than that of severe aplastic anemia. Clinical observation is often used and the treatment should be given according to the follow-up results of peripheral blood routine and the survival condition of the patients. In recent years, a number of studies at home or abroad have tended to intervene earlier. The risk of observation and waiting for disease progression is higher. Early immunosuppression should be considered. For the treatment of non transfusion dependent non severe aplastic anemia, the commonly used treatment regimen is androgen combined with CSA. But the investigators find that Levamisole hydrochloride (LMS) as a commonly used immunomodulatory drugs may be helpful to improving immune disorder symptoms in NSAA patients. Therefore,the investigators are conducting a prospective, randomized controlled study to compare the rate, side effects and long-term survival in non transfusion dependent patients with NSAA between the androgen+CSA group and the androgen+CSA+LMS group.

Condition or disease Intervention/treatment Phase
Aplastic Anemia Drug: levamisole hydrochloride Drug: Androgens Drug: Cyclosporins Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Clinical Study of Non Transfusion Dependent Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole Hydrochloride
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
the patients treated with levamisole hydrochloride 150mg qod +androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year
Drug: levamisole hydrochloride
levamisole hydrochloride take orally 150mg qod
Other Name: levamisole

Drug: Androgens
Androgens take orally 80mg qd

Drug: Cyclosporins
Cyclosporines take orally 3-5mg/kg*d qd

control group
the patients treated without levamisole hydrochloride,but androgens 80mg qd+cyclosporins 3-5mg/kg*d at least for one year
Drug: Androgens
Androgens take orally 80mg qd

Drug: Cyclosporins
Cyclosporines take orally 3-5mg/kg*d qd




Primary Outcome Measures :
  1. Routine blood test [ Time Frame: up to 4 weeks ]
    hemoglobin;white blood cell;Platelet


Secondary Outcome Measures :
  1. Bone marrow [ Time Frame: 1 year ]
    The proliferation of cells in bone marrow

  2. biochemical test [ Time Frame: up to 4 weeks ]
    Alanine aminotransferase;Aspartate aminotransferase



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218657


Contacts
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Contact: Lin S Yun, master 13588887285 lsyww2003@163.com
Contact: shen y Ying, master 18368023551 413808426@qq.com

Locations
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China, Zhejiang
Zhejiang Province Traditional Chinese Medical Hospital Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Lin s Yun, master    13588887285    lsyww2003@163.com   
Sponsors and Collaborators
Shengyun Lin

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Responsible Party: Shengyun Lin, Chief, Zhejiang Provincial Hospital of TCM
ClinicalTrials.gov Identifier: NCT03218657     History of Changes
Other Study ID Numbers: AA-LSA/SA
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shengyun Lin, Zhejiang Provincial Hospital of TCM:
Aplastic Anemia
levamisole hydrochloride
clinical study
Additional relevant MeSH terms:
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Androgens
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
Ascorbic Acid
Cyclosporine
Levamisole
Methyltestosterone
Cyclosporins
Estrogens, Conjugated (USP)
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antioxidants
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens