Trials / Unknown
UnknownNCT01760096
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (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 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
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 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone) |
| DRUG | cyclosporin A+Glucocorticoids | cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone) |
| DRUG | Glucocorticoids | Glucocorticoids0.25mg/kg every day(prednisone) |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2016-07-01
- Completion
- 2017-07-01
- First posted
- 2013-01-03
- Last updated
- 2013-01-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01760096. Inclusion in this directory is not an endorsement.