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NCT01760096 Clinical Trial

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)

Thrombosis Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01760096
Other study ID # PNH-2013
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received January 1, 2013
Last updated January 1, 2013
Start date January 2013
Est. completion date July 2017

Study information
Verified date January 2013
Source Institute of Hematology & Blood Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date July 2017
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Institute of Hematology & Blood Diseases Hospital, Tianjin Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, Hillmen P, Luzzatto L, Young N, Kinoshita T, Rosse W, Socié G; International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005 Dec 1;106(12):3699-709. Epub 2005 Jul 28. Review. — View Citation

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