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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: 19 February 2015
Main ID:  NCT00001287
Date of registration: 03/11/1999
Prospective Registration: No
Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Public title: Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Scientific title: The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Date of first enrolment: December 1990
Target sample size: 60
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00001287
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Selected patients should have CIDP with or without an associated monoclonal gammopathy.

Subjects should have clinical evidence of peripheral neuropathy with muscle weakness and
sensory deficit.

Subjects should have evidence of clinical, histological or family history of another
neuromuscular illness.

Subjects should have elevation of CSF protein during the course of the disease.

Subjects should have demyelination by nerve conduction study and/or nerve biopsy.

Suitable candidates for IVIg should be patients with active, bonefide CIDP who:

1. have been treated with steroids but had: a) no response or incomplete response (as
defined by continued muscle weakness) to high-dose therapy or b) a good response to
steroids but inability to taper the dose without a flare of disease activity or c)
unacceptable steroid side effects such as gastrointestinal hemorrhages,
osteonecrosis, hyperglycemia, extreme weight gain etc. or

2. have been additionally treated with one of the other immunosuppressive agents
considered effective in some CIDP patients, such as azathioprine, chlorambucil,
cyclophosphamide, cyclosporine or plasmapheresis but without benefit or with
unacceptable side effects that had necessitated their discontinuation.

Subjects should not be pregnant or nursing.

Subjects should not be critically ill such as those requiring intravenous pressors for
maintenance of cardiac output, patients with unstable respiratory insufficiency and
patients with such severe muscle weakness requiring help for basic self care (Karnofsky
performance scale less than 50).

No subjects below 18 years of age.

Patients should not have severe renal or hepatic disease and severe COPD or coronary
artery disease.

Patients should not be allergic to IVIg or have a known IgA deficiency.



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Demyelinating Diseases
Paraproteinemias
Intervention(s)
Drug: intravenous immunoglobulin (IVIg)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
91-N-0039
910039
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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