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Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

NCT02293460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-01-27

Study results available
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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

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

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.

Sponsors & Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Eduardo NOBILE-ORAZIO, MD · IRCCS Instituto Clinico Humanitas, Milano, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-09-29
Completion
2017-09-29

Countries

  • France
  • Italy
  • Spain
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293460 on ClinicalTrials.gov