This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01760096
First received: January 1, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose
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

Condition Intervention Phase
Paroxysmal Nocturnal Hemoglobinuria Hemoglobinuria Hemoglobinuria, Paroxysmal Proteinuria Urination Disorders Thrombosis Bone Marrow Failure Aplastic Anemia, Anemia, Hemolytic Drug: Levamisole+cyclosporin A+Glucocorticoids Drug: cyclosporin A+Glucocorticoids Drug: Glucocorticoids Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital:

Primary Outcome Measures:
  • Number of patients in each group in complete or partial remission [ Time Frame: 6 months ]
    she got blood transfusion-independent,the hemoglobin became higher


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levamisole+cyclosporin A+Glucocorticoids
Levamisole+cyclosporin A+Glucocorticoids
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)
Other Names:
  • Levamisole
  • cyclosporin A
  • Glucocorticoids
Active Comparator: cyclosporin A+Glucocorticoids
cyclosporin A+Glucocorticoids
Drug: cyclosporin A+Glucocorticoids
cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
Other Names:
  • cyclosporin A
  • Glucocorticoids
Active Comparator: Glucocorticoids
Glucocorticoids
Drug: Glucocorticoids
Glucocorticoids0.25mg/kg every day(prednisone)

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760096

Locations
China, Tianjin
Institute of Hematology & Blood Diseases Hospital,
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
Principal Investigator: yizhou zheng, doctor Institute of Hematology & Blood Diseases Hospital
  More Information

Additional Information:
CBD  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Yizhou Zheng, Vice director of the therapeutic centre of anemic diseases, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT01760096     History of Changes
Other Study ID Numbers: PNH-2013
Study First Received: January 1, 2013
Last Updated: January 1, 2013

Keywords provided by Yizhou Zheng, Institute of Hematology & Blood Diseases Hospital:
Paroxysmal Nocturnal Hemoglobinuria
Anemia
Hematologic Diseases
bone marrow failure
Immunologic Factors
Physiological Effects of Drugs
Levamisole
cyclosporine A

Additional relevant MeSH terms:
Anemia
Thrombosis
Anemia, Aplastic
Proteinuria
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Pancytopenia
Urination Disorders
Anemia, Hemolytic
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bone Marrow Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Myelodysplastic Syndromes
Cyclosporins
Cyclosporine
Levamisole
Glucocorticoids
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 21, 2017