NCT01642979

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

Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Paroxysmal Nocturnal Hemoglobinuria
• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Proteinuria
• Urination Disorders
• Thrombosis
• Bone Marrow Failure
• Aplastic Anemia,
• Anemia, Hemolytic

Interventions

Type	Name	Description
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)
DRUG	cyclosporin A+Glucocorticoids	cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)
DRUG	Glucocorticoids	Glucocorticoids 0.5-1mg/kg every day(prednisone)

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-07-01
• Completion: 2017-07-01
• First posted: 2012-07-17
• Last updated: 2013-01-03

Locations

1 site across 1 country: China