Trials / Terminated
TerminatedNCT02317562
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302"
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 19 (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 administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302). Secondary objective: To assess the safety of I10E in this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | I10E | Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks. |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2017-07-28
- Completion
- 2017-07-28
- First posted
- 2014-12-16
- Last updated
- 2021-04-20
- Results posted
- 2021-04-20
Locations
30 sites across 6 countries: France, Italy, Spain, Tunisia, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02317562. Inclusion in this directory is not an endorsement.