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Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT02027701 | PHASE 3 | INTERVENTIONAL

This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy. Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight \[bw\]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn. The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).

Trial Information
33 Sites
82 Participants
Recruiting
18 Years to 65 Years

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Birmingham,Alabama,United States,35294
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Los Angeles,California,United States,90033
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Kansas City,Kansas,United States,66160
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New York,New York,United States,10021
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Charlotte,North Carolina,United States,28210
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Woolloongabba,Queensland,Australia,4102
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Fitzroy,Victoria,Australia,3065
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Toronto,Ontario,Canada,M5G2C4
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Greenfield Park,Quebec,Canada,J4V2J2
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Hradec Kralove,Czechia,50003
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Hradec Kralove,Czechia,50005
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Nice Cedex 1,France,06002
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Essen,Nordrhein-Westfalen,Germany,45117
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Berlin,Germany,10117
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Berlin,Germany,12200
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Bochum,Germany,44791
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Essen,Germany,45147
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Hannover,Germany,30625
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Leipzig,Germany,DE04103
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Potsdam,Germany,14471
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Wurzburg,Germany,97080
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Milano,Italy,20133
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Tokorozawa,Saitama,Japan,359-8513
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Ube,Yamaguchi,Japan,755-8505
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Chiba,Japan,260-8677
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Kanagawa,Japan,228-8555
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Nagoya,Japan,466-8560
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Tokyo,Japan,113-8431
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Amsterdam,Netherlands,1105
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Barcelona,Spain,08035
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Barcelona,Spain,08907
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London,United Kingdom,WC1N3BG
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Salford,United Kingdom,M68HD

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov