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 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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01760096

Enrollment

Registered

2013-01-03

Start date

2013-01-31

Completion date

2017-07-31

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Paroxysmal Nocturnal Hemoglobinuria, Anemia, Hematologic Diseases, bone marrow failure, Immunologic Factors, Physiological Effects of Drugs, Levamisole, cyclosporine A

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 Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

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 Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes

Interventions

DRUGLevamisole+cyclosporin A+Glucocorticoids

Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)

DRUGcyclosporin A+Glucocorticoids

cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)

DRUGGlucocorticoids

Glucocorticoids0.25mg/kg every day(prednisone)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026