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 2 Unknown 50 enrolled Institute of Hematology & Blood Diseases Hospital, China

RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start: 2013-01
Primary completion: 2016-07
Completion: 2017-07

Publications

Background Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socie G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. doi: 10.1182/blood-2005-04-1717. Epub 2005 Jul 28. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levamisole	Small molecule	2.5 mg/kg	—
Background	Cyclosporine	Peptide	3 mg/kg	—
Background	Cyclosporine	Peptide	5 mg/kg	—
Background	Prednisone	Other / unclassified	0.25 mg/kg	—

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)

Summary

Timeline

Publications

Drugs

Indications