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)

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:
NCT01760096
First received: January 1, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted

January 1, 2013
January 1, 2013
January 2013
July 2016   (final data collection date for primary outcome measure)
Number of patients in each group in complete or partial remission [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
she got blood transfusion-independent,the hemoglobin became higher
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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)
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)

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Paroxysmal Nocturnal Hemoglobinuria
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal
  • Proteinuria
  • Urination Disorders
  • Thrombosis
  • Bone Marrow Failure
  • Aplastic Anemia,
  • Anemia, Hemolytic
  • 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
  • Drug: cyclosporin A+Glucocorticoids
    cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
    Other Names:
    • cyclosporin A
    • Glucocorticoids
  • Drug: Glucocorticoids
    Glucocorticoids0.25mg/kg every day(prednisone)
    Other Name: Glucocorticoids
  • Experimental: Levamisole+cyclosporin A+Glucocorticoids
    Levamisole+cyclosporin A+Glucocorticoids
    Intervention: Drug: Levamisole+cyclosporin A+Glucocorticoids
  • Active Comparator: cyclosporin A+Glucocorticoids
    cyclosporin A+Glucocorticoids
    Intervention: Drug: cyclosporin A+Glucocorticoids
  • Active Comparator: Glucocorticoids
    Glucocorticoids
    Intervention: Drug: Glucocorticoids
Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socié G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. Epub 2005 Jul 28. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
July 2017
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01760096
PNH-2013
Yes
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
Institute of Hematology & Blood Diseases Hospital
Not Provided
Principal Investigator: yizhou zheng, doctor Institute of Hematology & Blood Diseases Hospital
Institute of Hematology & Blood Diseases Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP