A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
NCT ID: NCT04752566
Last Updated: 2025-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
57 participants
INTERVENTIONAL
2021-03-08
2022-08-03
Brief Summary
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This study will be conducted only at sites in Japan.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eculizumab
Participants will receive eculizumab.
Eculizumab
Eculizumab will be administered via IV infusion once a week for 4 weeks.
Placebo
Participants will receive placebo.
Placebo
Placebo will be administered via IV infusion once a week for 4 weeks.
Interventions
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Eculizumab
Eculizumab will be administered via IV infusion once a week for 4 weeks.
Placebo
Placebo will be administered via IV infusion once a week for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who were able to run prior to onset of GBS symptoms.
* Participants with onset of weakness due to GBS \< 2 weeks before screening.
* Participants unable to walk unaided for ≥ 5 meters (progressively deteriorating FG3 or FG4 to FG5).
* Participants who are already on IVIg or deemed eligible for and who will start IVIg.
* Participants who can start their first dose of study drug before the end of the IVIg treatment period.
Exclusion Criteria
* Participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study.
* Participants who have received rituximab within 12 weeks prior to screening.
* Participants who are being considered for or are already on plasmapheresis.
* Participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Bunkyō City, , Japan
Research Site
Chiba, , Japan
Research Site
Fukuoka, , Japan
Research Site
Hiroshima, , Japan
Research Site
Kagoshima, , Japan
Research Site
Kawagoe-shi, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Kitakyushu-shi, , Japan
Research Site
Kobe, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kurashiki-shi, , Japan
Research Site
Matsumoto-shi, , Japan
Research Site
Mitaka-shi, , Japan
Research Site
Nagoya, , Japan
Research Site
Niigata, , Japan
Research Site
Nishinomiya-shi, , Japan
Research Site
Sapporo, , Japan
Research Site
Sayama, , Japan
Research Site
Sendai, , Japan
Research Site
Shimotsuga-gun, , Japan
Research Site
Ube-shi, , Japan
Research Site
Yokohama, , Japan
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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ECU-GBS-301
Identifier Type: -
Identifier Source: org_study_id
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