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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 September 2021 |
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Main ID: |
NCT02465359 |
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Date of registration:
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12/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Subcutaneous Immunoglobulin for CIDP
SCIG |
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Scientific title:
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A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02465359 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Tuan Vu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of South Florida |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
To qualify, a patient must have CIDP and persistence of significant symptoms (having 2 or
more of the following):
- Weakness in any limb,
- Motor fatigue significant to interfere with ADL or work,
- Paresthesia of sufficient severity to require a medication,
- Sensory impairment,
- Walking impairment,
AND requires IVIG to control symptoms.
Exclusion Criteria:
1. Thrombocytopenia or other bleeding disorders,
2. Anticoagulation therapy,
3. Severe or anaphylactoid reactions to IVIG,
4. Cancer,
5. Pregnancy,
6. Breast-feeding,
7. Renal insufficiency or failure,
8. Congestive heart failure,
9. Psychiatric illness.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Inflammatory Demyelinating Polyneuropathy
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Intervention(s)
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Drug: Immune Globulin Subcutaneous (Human)
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Primary Outcome(s)
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Relapse of CIDP Symptoms
[Time Frame: 6 months]
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Secondary Outcome(s)
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CIP-PRO20
[Time Frame: Monthly for 6 months]
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Rasch-built Overall Disability Scale
[Time Frame: Monthly for 6 months]
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Short Form 36
[Time Frame: Monthly for six months]
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Treatment Satisfaction Questionnaire for Medication
[Time Frame: 2-6 weeks prior to Day 1 of treatment and then monthly for 6 months]
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Secondary ID(s)
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Pro00016957
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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