At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 44 enrolled
Drug / intervention
I10Edrug
Likely dose
I10E 2gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Laboratoire français de Fractionnement et de Biotechnologies·interventional·Posted Nov 18, 2014·Updated Jan 27, 2021
In Brief
A Phase 3 clinical trial evaluating I10E for Chronic Inflammatory Demyelinating Polyradiculoneuropathy. Completed, enrolled 44 participants across 33 sites in 6 countries.
Detailed Summary
Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Italy, Spain, Tunisia, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartMay 2015
Primary CompletionSep 2017
TodayJul 2026
First PostedNov 18, 2014
Enrollment StartMay 1, 2015
Primary CompletionSep 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.6 years ago
Interventions
I10Edrug
Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks. Duration of treatment period: 21 weeks +/- 7 days.