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

January 1, 2013 updated by: Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Institute of Hematology & Blood Diseases Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical and biochemical signs of classic Paroxysmal Nocturnal Hemoglobinuria
  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
  5. patient who terminate ealy from levamisole study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levamisole+cyclosporin A+Glucocorticoids
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:
  • cyclosporin A
  • Levamisole
  • Glucocorticoids
Active Comparator: 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
Active Comparator: Glucocorticoids
Drug: Glucocorticoids
Glucocorticoids 0.5-1mg/kg every day(prednisone)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 14, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 1, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNH-2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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