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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: 17 October 2016
Main ID:  EUCTR2011-003448-28-DE
Date of registration: 31/01/2012
Prospective Registration: Yes
Primary sponsor: CSL Behring GmbH
Public title: Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)
Scientific title: Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH
Date of first enrolment: 20/04/2012
Target sample size: 350
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003448-28
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
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 Austria Belgium Canada Czech Republic Estonia Finland France
Germany Israel Italy Japan Lithuania Netherlands Poland Spain
United Kingdom United States
Contacts
Name: Trial Disclosure Manager   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
Name: Trial Disclosure Manager   
Address:  Emil-von-Behring-Strasse 76 35041 Marburg Germany
Telephone:
Email: clinicaltrials@cslbehring.com
Affiliation:  CSL Behring GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. Definite or probable CIDP according to the EFNS/PNS criteria 2010.
2. Repeated treatment with IVIG (= 4 doses) within the last 9 months prior to enrollment.
3. An IVIG treatment during the last 8 weeks prior to enrollment.
4. Age =18 years.
5. Male or female.
6. Written informed consent for study participation obtained before undergoing any studyspecific
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 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
1. Any polyneuropathy of other causes
2. Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
3. Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
4. History of thrombotic episodes within the 2 years prior to enrolment
5. Known allergic or other severe reactions to blood products including intolerability to previous IVIG


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 19.0 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)
CAS Number: 0
Current Sponsor code: IgPro10-SOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
Main Objective: To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.
Primary end point(s): Efficacy:
Percentage (%) of subjects who have a CIDP relapse during SC treatment or are withdrawn from the study during SC treatment for any reason.
Secondary Objective: - To investigate the efficacy of IgPro20 with additional clinical outcome measures in comparison to placebo.
- To investigate the safety and tolerability of IgPro20 in comparison to placebo.
- To investigate health-related quality of life (HRQL) following treatment with IgPro20.
- To investigate the safety and efficacy of IgPro10 re-stabilization therapy.
- To investigate the safety and efficacy of IgPro10 rescue therapy.
Timepoint(s) of evaluation of this end point: During SC treatment period - 24 weeks
Secondary Outcome(s)
Secondary end point(s): Efficacy:
• Changes in means at SC Treatment Period completion visit compared to baseline between groups in:
- INCAT score.
- Mean grip strength (dominant/non-dominant hand).
- MRC sum score.
- R-ODS.
• Difference in “time to CIDP relapse or withdrawal due to any other reason” using a Kaplan-Meier estimation comparing both IgPro20 groups with placebo as well as the 2 IgPro20 groups pairwise.
• Time to improvement on IgPro10 re-stabilization therapy (INCAT, R-ODS, Grip strength).
• Changes in means before and at the end of IgPro10 re-stabilization or rescue therapy in
- Mean grip strength (dominant/non-dominant hand).
- MRC sum score.
- R-ODS.
- INCAT disability score.
• Time to improvement after CIDP relapse in the SC Treatment Period and IgPro10 rescue therapy, defined as a decrease in INCAT score back to or below baseline.
Safety:
• For IgPro20: Rate of AEs per infusion, number and % of subjects with AEs during the SC Treatment Period
• For IgPro10: rate of AEs per infusion, number and % of subjects with AEs during IVIG Restabilization Period and during IVIG rescue therapy.
Timepoint(s) of evaluation of this end point: During study - up to 52 weeks
Secondary ID(s)
IgPro20_3003
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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