Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria (PNH-2012)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital

ClinicalTrials.gov Identifier:

NCT01642979

First received: July 14, 2012

Last updated: January 1, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2012

Last Updated Date

January 1, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

July 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of patients in each group in complete or partial remission [ Time Frame: 6 months ] [ Designated as safety issue: No ]

she got blood transfusion-independent,the hemoglobin became higher

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01642979 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

Official Title ^ICMJE

Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria

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 classic paroxysmal nocturnal hemoglobinuria.

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 classic paroxysmal nocturnal hemoglobinuria

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Levamisole+cyclosporin A+Glucocorticoids
Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone)
Other Names:
- Levamisole
- cyclosporin A
- Glucocorticoids
Drug: cyclosporin A+Glucocorticoids
cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)
Other Names:
- cyclosporin A
- Glucocorticoids
Drug: Glucocorticoids
Glucocorticoids 0.5-1mg/kg every day(prednisone)

Other Name: Glucocorticoids

Study Arm (s)

Experimental: Levamisole+cyclosporin A+Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids

Intervention: Drug: Levamisole+cyclosporin A+Glucocorticoids
Active Comparator: cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids

Intervention: Drug: cyclosporin A+Glucocorticoids
Active Comparator: Glucocorticoids
Glucocorticoids

Intervention: Drug: Glucocorticoids

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

July 2017

Estimated Primary Completion Date

July 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
patient should complete levamisole study for at least half a year

Exclusion Criteria:

Active infection which requires antibiotic treatment
Pregnant or lactating women
Epilepsy and mental illness
Kidney and liver function abnormal
patient who terminate ealy from levamisole study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01642979

Other Study ID Numbers ^ICMJE

PNH-2012

Has Data Monitoring Committee

Yes

Responsible Party

Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital

Study Sponsor ^ICMJE

Institute of Hematology & Blood Diseases Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

yizhou zheng, doctor

Institute of Hematology & Blood Diseases Hospital

Information Provided By

Institute of Hematology & Blood Diseases Hospital

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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