Overview

This trial is active, not recruiting.

Conditions paroxysmal nocturnal hemoglobinuria, hemoglobinuria, hemoglobinuria, paroxysmal, proteinuria, urination disorders, thrombosis, bone marrow failure, aplastic anemia,, anemia, hemolytic
Treatments levamisole+cyclosporin a+glucocorticoids, cyclosporin a+glucocorticoids, glucocorticoids
Phase phase 2
Sponsor Institute of Hematology & Blood Diseases Hospital
Start date January 2013
End date July 2016
Trial size 50 participants
Trial identifier NCT01760096, PNH-2013

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Levamisole+cyclosporin A+Glucocorticoids
levamisole+cyclosporin a+glucocorticoids Levamisole
Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)
(Active Comparator)
cyclosporin A+Glucocorticoids
cyclosporin a+glucocorticoids cyclosporin A
cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
(Active Comparator)
Glucocorticoids
glucocorticoids Glucocorticoids
Glucocorticoids0.25mg/kg every day(prednisone)

Primary Outcomes

Measure
Number of patients in each group in complete or partial remission
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator yizhou zheng, doctor
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Institute of Hematology & Blood Diseases Hospital.