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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02465359
Date of registration: 12/12/2014
Prospective Registration: Yes
Primary sponsor: University of South Florida
Public title: Subcutaneous Immunoglobulin for CIDP SCIG
Scientific title: A Study of Subcutaneous Immunoglobulin as Chronic Treatment for Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Date of first enrolment: September 2014
Target sample size: 20
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02465359
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Tuan Vu, MD
Address: 
Telephone:
Email:
Affiliation:  University of South Florida
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention(s)
Drug: Immune Globulin Subcutaneous (Human)
Primary Outcome(s)
Relapse of CIDP Symptoms [Time Frame: 6 months]
Secondary Outcome(s)
CIP-PRO20 [Time Frame: Monthly for 6 months]
Rasch-built Overall Disability Scale [Time Frame: Monthly for 6 months]
Short Form 36 [Time Frame: Monthly for six months]
Treatment Satisfaction Questionnaire for Medication [Time Frame: 2-6 weeks prior to Day 1 of treatment and then monthly for 6 months]
Secondary ID(s)
Pro00016957
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
CSL Behring
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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