Trials / Completed
CompletedNCT02293460
Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | I10E | 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. |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2017-09-29
- Completion
- 2017-09-29
- First posted
- 2014-11-18
- Last updated
- 2021-01-27
- Results posted
- 2020-03-09
Locations
33 sites across 6 countries: France, Italy, Spain, Tunisia, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02293460. Inclusion in this directory is not an endorsement.