A Phase 3 Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barre Syndrome
- Conditions
- Guillain-Barre Syndrome
- Registration Number
- JPRN-jRCT2031200420
- Lead Sponsor
- Ishida Hirokazu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 57
Participants who meet the GBS criteria.
- Participants who are able to run prior to onset of GBS symptoms.
- Participants with onset of weakness due to GBS less than 2 weeks before screening.
- Participants unable to walk unaided for 5 or more 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.
- Participants who have previously received or are currently receiving treatment with complement modulators.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first reaching a Hughes Functional Grade (FG) score 1 or less
- Secondary Outcome Measures
Name Time Method - Proportion of patients with a Hughes FG score 1 or less at Week 24<br>- Proportion of patients with a Hughes FG score improvement of 3 or more at Week 24<br>- Proportion of patients with a Hughes FG score 1 or less at Week 8<br>- Incidence of treatment-emergent adverse events<br>- Free complement component 5 (C5) in serum<br>- Hemolytic complement activity in serum<br>- Hospital length of stay (LOS)<br>- Duration of ventilator support<br>- Concentration of eculizumab in serum<br>- Incidence of ADAs