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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02027701




Registration number
NCT02027701
Ethics application status
Date submitted
3/01/2014
Date registered
6/01/2014
Date last updated
2/10/2018

Titles & IDs
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
Secondary ID [1] 0 0
2013-004157-24
Secondary ID [2] 0 0
IgPro20_3004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 0 0
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: IgPro20 - 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse Events (AEs) Per Infusion
Timepoint [1] 0 0
Up to 49 weeks
Secondary outcome [1] 0 0
Time to First CIDP Relapse
Timepoint [1] 0 0
Up to 49 weeks
Secondary outcome [2] 0 0
Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
Timepoint [2] 0 0
Baseline and up to 49 weeks
Secondary outcome [3] 0 0
Change From Baseline in Medical Research Council (MRC) Score
Timepoint [3] 0 0
Baseline and up to 49 weeks
Secondary outcome [4] 0 0
Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)
Timepoint [4] 0 0
Baseline and up to 49 weeks
Secondary outcome [5] 0 0
Change From Baseline in Mean Grip Strength
Timepoint [5] 0 0
Baseline and up to 49 weeks
Secondary outcome [6] 0 0
Percentage of Subjects With Adverse Events (AEs)
Timepoint [6] 0 0
Up to 49 weeks
Secondary outcome [7] 0 0
Number of AEs by Severity Per Infusion
Timepoint [7] 0 0
Up to 49 weeks
Secondary outcome [8] 0 0
Percentage of Subjects With AEs by Severity
Timepoint [8] 0 0
Up to 49 weeks
Secondary outcome [9] 0 0
Number of Causally Related AEs Per Infusion
Timepoint [9] 0 0
Up to 49 weeks
Secondary outcome [10] 0 0
Percentage of Subjects With Causally Related AEs
Timepoint [10] 0 0
Up to 49 weeks
Secondary outcome [11] 0 0
Number of Serious AEs Per Infusion
Timepoint [11] 0 0
Up to 49 weeks
Secondary outcome [12] 0 0
Percentage of Subjects With Serious AEs
Timepoint [12] 0 0
Up to 49 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/07/2017
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Site Reference 0360017 - Woolloongabba
Recruitment hospital [2] 0 0
Site Reference 0360011 - Fitzroy
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
France
State/province [9] 0 0
Nice Cedex 1
Country [10] 0 0
Germany
State/province [10] 0 0
Nordrhein-Westfalen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Bochum
Country [13] 0 0
Germany
State/province [13] 0 0
Essen
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Germany
State/province [15] 0 0
Leipzig
Country [16] 0 0
Germany
State/province [16] 0 0
Potsdam
Country [17] 0 0
Germany
State/province [17] 0 0
Wurzburg
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Japan
State/province [19] 0 0
Saitama
Country [20] 0 0
Japan
State/province [20] 0 0
Yamaguchi
Country [21] 0 0
Japan
State/province [21] 0 0
Chiba
Country [22] 0 0
Japan
State/province [22] 0 0
Kanagawa
Country [23] 0 0
Japan
State/province [23] 0 0
Nagoya
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
Country [25] 0 0
Netherlands
State/province [25] 0 0
Amsterdam
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
United Kingdom
State/province [27] 0 0
London
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Dr. Ivo N. van Schaik
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02027701