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Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)

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ClinicalTrials.gov Identifier: NCT01760096
Recruitment Status : Unknown
Verified January 2013 by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital

Study Description
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Brief Summary:
Paroxysmal nocturnal hemoglobinuria is an acquired chronic hemolytic anemia,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

Condition or disease Intervention/treatment Phase
Paroxysmal Nocturnal Hemoglobinuria Hemoglobinuria Hemoglobinuria, Paroxysmal Proteinuria Urination Disorders Thrombosis Bone Marrow Failure Aplastic Anemia, Anemia, Hemolytic Drug: Levamisole+cyclosporin A+Glucocorticoids Drug: cyclosporin A+Glucocorticoids Drug: Glucocorticoids Phase 2

Detailed Description:
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal disorder of the hematopoietic stem cell characterized by intravascular hemolysis, hemoglobinuria, anemia, and thrombosis, Patients may be at high risk of thrombosis and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts,because the manifestation and pathologic processes are complicate,the treatment is very difficult,this study is designed to evaluate the safety and efficacy of Levamisole combined with cyclosporine A in patients with Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)
Study Start Date : January 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017

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MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: Levamisole+cyclosporin A+Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids
 Drug: Levamisole+cyclosporin A+Glucocorticoids
Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)
Other Names:
  • Levamisole
  • cyclosporin A
  • Glucocorticoids
Active Comparator: cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
 Drug: cyclosporin A+Glucocorticoids
cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
Other Names:
  • cyclosporin A
  • Glucocorticoids
Active Comparator: Glucocorticoids
Glucocorticoids
 Drug: Glucocorticoids
Glucocorticoids0.25mg/kg every day(prednisone)


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients in each group in complete or partial remission [ Time Frame: 6 months ]
    she got blood transfusion-independent,the hemoglobin became higher


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical and biochemical signs of Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes
  2. Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
  3. patient should complete levamisole study for at least half a year

Exclusion Criteria:

  1. Active infection which requires antibiotic treatment
  2. Pregnant or lactating women
  3. Epilepsy and mental illness
  4. Kidney and liver function abnormal
Contacts and Locations
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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): NCT01760096


Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital,
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: yizhou zheng, doctor Institute of Hematology & Blood Diseases Hospital
More Information
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Additional Information:
CBD  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT01760096    
Other Study ID Numbers: PNH-2013
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013
Keywords provided by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital:
Paroxysmal Nocturnal Hemoglobinuria
Anemia
Hematologic Diseases
bone marrow failure
 Immunologic Factors
Physiological Effects of Drugs
Levamisole
cyclosporine A
Additional relevant MeSH terms:
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Proteinuria
Hemoglobinuria
Urination Disorders
Thrombosis
Anemia
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Pancytopenia
Anemia, Hemolytic
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bone Marrow Diseases
Urologic Diseases
 Urological Manifestations
Signs and Symptoms
Myelodysplastic Syndromes
Cyclosporine
Levamisole
Cyclosporins
Glucocorticoids
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents