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)
NCT01760096 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2013-01-03
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
Conditions
- Paroxysmal Nocturnal Hemoglobinuria
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
- Proteinuria
- Urination Disorders
- Thrombosis
- Bone Marrow Failure
- Aplastic Anemia,
- Anemia, Hemolytic
Interventions
- 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
-
Glucocorticoids0.25mg/kg every day(prednisone)
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Principal Investigators
-
yizhou zheng, doctor · Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2016-07-31
- Completion
- 2017-07-31
Countries
- China
Study Locations
More Related Trials
-
Electronic Patient-reported Outcome Monitoring in Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
NCT04128943 ·Status: COMPLETED
-
Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT06933914 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Natural History Study of Adult Patients With Paroxysmal Nocturnal Hemoglobinuria of High-risk Hemolysis in China
NCT05125341 ·Status: COMPLETED
-
Tacrolimus Treatment for Refractory Autoimmune Cytopenia
NCT03918265 ·Status: UNKNOWN ·Phase: PHASE4
-
Haploidentical PBMC Transplant for Severe Congenital Anemias
NCT00977691 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Unrelated Umbilical Cord Blood Following HLA-haploidentical Hematopoietic Stem Cell Transplantation in Patients With β-thalassemia Major
NCT02126046 ·Status: UNKNOWN ·Phase: NA
-
Improving the Results of Bone Marrow Transplantation for Patients With Severe Congenital Anemias
NCT00061568 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Transfer of GPI-Linked Proteins to Transfused Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT00039923 ·Status: COMPLETED
-
Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment
NCT04558918 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias
NCT00061763 ·Status: COMPLETED ·Phase: PHASE2
-
Zoledronic Acid for the Prevention of Bone Loss Post-bone Marrow Transplantation for Thalassemia Major Patients
NCT01016093 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms
NCT02823184 ·Status: COMPLETED
-
Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease
NCT05445128 ·Status: TERMINATED ·Phase: PHASE2
-
HLA Haploidentical Bone Marrow Transplant in Patients With Severe Sickle Cell Disease
NCT03240731 ·Status: COMPLETED ·Phase: PHASE2
-
Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia
NCT01362595 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
β-globin Restored Autologous HSC in β-thalassemia Major Patients
NCT04205435 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
NCT01224483 ·Status: UNKNOWN
-
Evaluating Safety and Efficacy of Lentiviral-transduced CD34+ HSCs in Β-thalassaemia Patients.
NCT06655662 ·Status: RECRUITING ·Phase: PHASE1
-
Second-line Treatment of Primary Autoimmune Hemolytic Anemia
NCT05057468 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major
NCT02342145 ·Status: COMPLETED ·Phase: PHASE4
-
Tacrolimus Treatment for Refractory PRCA
NCT03540472 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety Evaluation Study for Patients With Polycythemia Vera
NCT05074550 ·Status: UNKNOWN ·Phase: PHASE1
-
the Safety and Efficacy Evaluation of HGI-001 Injection in Patients With Transfusion-Dependent β-Thalassemia
NCT05864170 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH
NCT03866681 ·Status: UNKNOWN ·Phase: PHASE4
-
An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old
NCT01724138 ·Status: WITHDRAWN ·Phase: PHASE4