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Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria (PNH-2012)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01642979
First received: July 14, 2012
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  Purpose

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 classic paroxysmal nocturnal hemoglobinuria.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Hematology & Blood Diseases Hospital:

Primary Outcome Measures:
  • Number of patients in each group in complete or partial remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    she got blood transfusion-independent,the hemoglobin became higher


Secondary Outcome Measures:
  • Side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levamisole+cyclosporin A+Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids
 Drug: Levamisole+cyclosporin A+Glucocorticoids
Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone)
Other Names:
  • Levamisole
  • cyclosporin A
  • Glucocorticoids
Active Comparator: cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
 Drug: cyclosporin A+Glucocorticoids
cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)
Other Names:
  • cyclosporin A
  • Glucocorticoids
Active Comparator: Glucocorticoids
Glucocorticoids
 Drug: Glucocorticoids
Glucocorticoids 0.5-1mg/kg every day(prednisone)
Other Name: Glucocorticoids

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 classic paroxysmal nocturnal hemoglobinuria

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
  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
  5. patient who terminate ealy from levamisole study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642979

Locations
China, Tianjin
Institute of Hematology & Blood Diseases Hospital,
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
Principal Investigator: yizhou zheng, doctor Institute of Hematology & Blood Diseases Hospital
  More Information

Additional Information:
CBD  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT01642979     History of Changes
Other Study ID Numbers: PNH-2012
Study First Received: July 14, 2012
Last Updated: January 1, 2013
Health Authority: China: Ethics Committee

Keywords provided by 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:
Anemia
Anemia, Aplastic
Anemia, Hemolytic
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Pancytopenia
Proteinuria
Thrombosis
Urination Disorders
Hemolysis
Hematologic Diseases
Bone Marrow Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
 Myelodysplastic Syndromes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cyclosporins
Cyclosporine
Levamisole
Glucocorticoids
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013