Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT ID: NCT02027701
Last Updated: 2018-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
82 participants
INTERVENTIONAL
2014-07-30
2017-07-10
Brief Summary
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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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IgPro20
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
IgPro20
Interventions
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IgPro20
Eligibility Criteria
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Inclusion Criteria
* Written informed consent for study participation obtained before undergoing any study-specific procedures.
Exclusion Criteria
* New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20\_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of investigational medicinal product, and/or conduct of the study.
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. Ivo N. van Schaik
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Site Reference 8400181
Birmingham, Alabama, United States
Site Reference 8400167
Los Angeles, California, United States
Site Reference 8400166
Kansas City, Kansas, United States
Site Reference 8400169
New York, New York, United States
Site Reference 8400182
Charlotte, North Carolina, United States
Site Reference 0360017
Woolloongabba, Queensland, Australia
Site Reference 0360011
Fitzroy, Victoria, Australia
Site Reference 1240009
Toronto, Ontario, Canada
Site Reference 1240007
Greenfield Park, Quebec, Canada
Site Reference 2030009
Hradec Králové, , Czechia
Site Reference 2030002
Hradec Králové, , Czechia
Site Reference 2500022
Nice, , France
Site Reference 2760052
Essen, North Rhine-Westphalia, Germany
Site Reference 2760069
Berlin, , Germany
Site Reference 2760072
Berlin, , Germany
Site Reference 2760049
Bochum, , Germany
Site Reference 2760094
Essen, , Germany
Site Reference 2760054
Hanover, , Germany
Site Reference 2760055
Leipzig, , Germany
Site Reference 2760047
Potsdam, , Germany
Site Reference 2760039
Würzburg, , Germany
Site Reference 3800031
Milan, , Italy
Site Reference 3920037
Tokorozawa, Saitama, Japan
Site Reference 3920035
Ube, Yamaguchi, Japan
Site Reference 3920038
Chiba, , Japan
Site Reference 3920061
Kanagawa, , Japan
Site Reference 3920040
Nagoya, , Japan
Site Reference 3920065
Tokyo, , Japan
Site Reference 5280001
Amsterdam, , Netherlands
Site Reference 7240011
Barcelona, , Spain
Site Reference 7240010
Barcelona, , Spain
Site Reference 8260019
London, , United Kingdom
Site Reference 8260032
Salford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004157-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IgPro20_3004
Identifier Type: -
Identifier Source: org_study_id
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