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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: 22 January 2018
Main ID:  EUCTR2013-004157-24-FI
Date of registration: 19/03/2014
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: 04/04/2014
Target sample size: 40
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: no
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 States
Contacts
Name: Clin Trial Registration Coordinator   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
Name: Clin 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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
• Subjects unable to directly transition from pivotal study IgPro20_3003, i.e., the subject ins unable to have the baseline visit conducted at the same time as the completion visit for the pivotal study IgPro20_3003
• New medical condition and/or social behavior (i.e. alcohol, drug, or medication abuse) during participation in pivotal 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.
• Pregnant or intention to become pregnant during the course of the study.
• Female subjects of childbearing potential either not using, or not willing to continue to use, a medically reliable method of contraception for the entire duration 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: 17.1 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)
Main Objective: To evaluate long-term safety of IgPro20.
Primary end point(s): Overall rate of adverse events (AEs) per infusion
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
Secondary Outcome(s)
Secondary end point(s): Safety
• Overall rate of AEs per infusion (by system organ class [SOC], preferred term [PT], severity, causality, and seriousness).
• Percentage of subjects with AEs (overall, and by SOC, PT, severity, causality, seriousness).
• Rate of AEs per infusion (by SOC, PT, severity, causality, and seriousness) by dose.
• Percentage of subjects with AEs (overall, and by SOC, PT, severity, causality, seriousness) by dose.
Efficacy
• Changes from baseline in total adjusted INCAT score, MRC sum score, R-ODS, and mean grip strength.
• Time to first relapse based on adjusted INCAT score.
Timepoint(s) of evaluation of this end point: Safety = Up to 49 weeks
Efficacy = Up to 49 weeks
Secondary ID(s)
2013-004157-24-IT
34/2014
IgPro20_3004
Source(s) of Monetary Support
CSL Behring GmbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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