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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02027701
Date of registration: 03/01/2014
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Scientific title: Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003
Date of first enrolment: July 30, 2014
Target sample size: 82
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02027701
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Australia Canada Czech Republic Czechia Finland France Germany Italy
Japan Netherlands Spain United Kingdom United States
Contacts
Name:     Prof. Dr. Ivo N. van Schaik
Address: 
Telephone:
Email:
Affiliation:  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully
rescued from a CIDP relapse during the SC Treatment Period of pivotal study
IgPro20_3003 (NCT01545076).

- Written informed consent for study participation obtained before undergoing any
study-specific procedures.

Exclusion Criteria:

- Subject is unable to directly transition from study IgPro20_3003.

- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse)
during participation in study IgPro20_3003 that in the judgment of the investigator
could increase risk to the subject, interfere with the evaluation of investigational
medicinal product, and/or conduct of the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention(s)
Biological: IgPro20
Primary Outcome(s)
Number of Adverse Events (AEs) Per Infusion [Time Frame: Up to 49 weeks]
Secondary Outcome(s)
Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score [Time Frame: Baseline and up to 49 weeks]
Change From Baseline in Mean Grip Strength [Time Frame: Baseline and up to 49 weeks]
Change From Baseline in Medical Research Council (MRC) Score [Time Frame: Baseline and up to 49 weeks]
Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) [Time Frame: Baseline and up to 49 weeks]
Number of AEs by Severity Per Infusion [Time Frame: Up to 49 weeks]
Number of Causally Related AEs Per Infusion [Time Frame: Up to 49 weeks]
Number of Serious AEs Per Infusion [Time Frame: Up to 49 weeks]
Percentage of Subjects With Adverse Events (AEs) [Time Frame: Up to 49 weeks]
Percentage of Subjects With AEs by Severity [Time Frame: Up to 49 weeks]
Percentage of Subjects With Causally Related AEs [Time Frame: Up to 49 weeks]
Percentage of Subjects With Serious AEs [Time Frame: Up to 49 weeks]
Time to First CIDP Relapse [Time Frame: Up to 49 weeks]
Secondary ID(s)
2013-004157-24
IgPro20_3004
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 02/10/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02027701
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