- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01760096
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)
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 Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)
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
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 Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes
Study Type
Interventional
Enrollment (Anticipated)
50
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
-
-
Tianjin
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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:
- Clinical and biochemical signs of Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the setting of another bone marrow failure syndromes
- 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
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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:
|
ACTIVE_COMPARATOR: cyclosporin A+Glucocorticoids
|
cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg
every day(prednisone)
Other Names:
|
ACTIVE_COMPARATOR: Glucocorticoids
|
Glucocorticoids0.25mg/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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
January 1, 2013
Primary Completion (ANTICIPATED)
July 1, 2016
Study Completion (ANTICIPATED)
July 1, 2017
Study Registration Dates
First Submitted
January 1, 2013
First Submitted That Met QC Criteria
January 1, 2013
First Posted (ESTIMATE)
January 3, 2013
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
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Urological Manifestations
- Bone Marrow Diseases
- Hematologic Diseases
- Embolism and Thrombosis
- Myelodysplastic Syndromes
- Proteinuria
- Anemia
- Thrombosis
- Anemia, Aplastic
- Bone Marrow Failure Disorders
- Pancytopenia
- Hemoglobinuria
- Hemoglobinuria, Paroxysmal
- Urination Disorders
- Anemia, Hemolytic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Adjuvants, Immunologic
- Antifungal Agents
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
- Levamisole
- Glucocorticoids
Other Study ID Numbers
- PNH-2013
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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