Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

Phase 2

• Conditions: Hemoglobinuria, Paroxysmal; Proteinuria; Urination Disorders; Thrombosis; Hemoglobinuria; Paroxysmal Nocturnal Hemoglobinuria; Bone Marrow Failure; Aplastic Anemia,; Anemia, Hemolytic
• Interventions: Drug: Levamisole+cyclosporin A+Glucocorticoids; Drug: cyclosporin A+Glucocorticoids; Drug: Glucocorticoids

• Registration Number: NCT01642979
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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 classic paroxysmal nocturnal hemoglobinuria.

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-14
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-01
• Last Update Posted: 2013-01-03
• Primary Completion: 2016-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levamisole+cyclosporin A+Glucocorticoids	Levamisole+cyclosporin A+Glucocorticoids	Levamisole+cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids	cyclosporin A+Glucocorticoids	cyclosporin A+Glucocorticoids
Glucocorticoids	Glucocorticoids	Glucocorticoids

Primary Outcome Measures

Name	Time	Method
Number of patients in each group in complete or partial remission	6 months	she got blood transfusion-independent,the hemoglobin became higher

Secondary Outcome Measures

Name	Time	Method
Side effects	6 months

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital,; 🇨🇳 Tianjin, Tianjin, China