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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: EUCTR
Last refreshed on: 30 April 2019
Main ID:  EUCTR2013-004157-24-GB
Date of registration: 18/02/2014
Prospective Registration: Yes
Primary sponsor: CSL Behring GmbH
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: 30/04/2014
Target sample size: 80
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004157-24
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Single group
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Canada Czech Republic European Union Finland Germany Italy Japan
Netherlands Spain United Kingdom United States
Contacts
Name: Trial Registration Coordinator   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
Name: Trial Registration Coordinator   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 IMP, and/or conduct of the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Hizentra®
Product Name: Hizentra®
Product Code: IgPro20
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Human normal immunoglobulin (SCIg)
Current Sponsor code: IgPro20
Other descriptive name: Hizentra®
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: - To evaluate the long-term safety of IgPro20 by dose.
- To evaluate the efficacy of IgPro20.


Timepoint(s) of evaluation of this end point: Up to 49 weeks
Main Objective: To evaluate long-term safety of IgPro20.
Primary end point(s): Overall Rate rate of adverse events (AEs) per infusion
Secondary Outcome(s)

Secondary end point(s): -Rate of adverse events (AEs) per infusion by severity, causality, and seriousness
-Percentage of subjects with AEs, overall and by severity, causality and seriousness
-Rate of adverse events (AEs) per infusion by severity, causality, and seriousness by IgPro20 dose level
-Percentage of subjects with adverse events (AEs) by severity, causality, and seriousness by IgPro20 dose level
-Change from baseline in total adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score
-Change from baseline in Medical Research Council (MRC) score
- Change from baseline in Rasch-built Overall Disability Scale (R-ODS)
-Change from baseline in mean grip strength
-Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).
Timepoint(s) of evaluation of this end point: Up to 49 weeks
Secondary ID(s)
IgPro20_3004
Source(s) of Monetary Support
CSL Behring GmbH
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 25/07/2018
Date Completed: 10/07/2017
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004157-24/results
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