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)

I

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Unknown
Phase 2

Conditions

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

Treatments

Drug: cyclosporin A+Glucocorticoids
Drug: Levamisole+cyclosporin A+Glucocorticoids
Drug: Glucocorticoids

Study type

Interventional

Funder types

Other

Identifiers

NCT01760096
PNH-2013

Details and patient eligibility

About

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

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 3 patient groups

Levamisole+cyclosporin A+Glucocorticoids
Experimental group
Description:
Levamisole+cyclosporin A+Glucocorticoids
Treatment:
Drug: Levamisole+cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
Active Comparator group
Description:
cyclosporin A+Glucocorticoids
Treatment:
Drug: cyclosporin A+Glucocorticoids
Glucocorticoids
Active Comparator group
Description:
Glucocorticoids
Treatment:
Drug: Glucocorticoids

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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