We're sorry, but this trial is no longer enrolling volunteers.
Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
Description
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
- An IVIG treatment during the last 8 weeks prior to enrollment.
- Age ≥18 years.
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
- Any polyneuropathy of other causes
- Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
- Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
- History of thrombotic episodes within the 2 years prior to enrolment
- Known allergic or other severe reactions to blood products including intolerability to previous IVIG
Sites
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California
- Site reference 8400167, Los Angeles, California, 90033
- Site reference 8400170, Orange, California, 92868
- Site reference 8400170, Orange, California, 92868
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Arizona
- Site reference 8400173, Phoenix, Arizona, 85013
- Site reference 8400172, Phoenix, Arizona, 85018
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Colorado
- Site reference 8400077, Centennial, Colorado, 80112
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Oklahoma
- Site reference 8400217, Oklahoma, Oklahoma, 73104
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Kansas
- Site reference 8400166, Kansas City, Kansas, 66160
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Texas
- Site reference 8400164, Houston, Texas, 77030
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Minnesota
- Site Reference 8400247, Minneapolis, Minnesota, 55454
- Site Reference 8400247, Minneapolis, Minnesota, 55454
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Illinois
- Site reference 8400162, Chicago, Illinois, 60611
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Tennessee
- Site Reference 8400177, Nashville, Tennessee, 37232
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Alabama
- Site reference 8400181, Birmingham, Alabama, 35233
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Indiana
- Site Reference 8400215, Indianapolis, Indiana, 46202
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