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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:  NCT01545076
Date of registration: 01/03/2012
Prospective Registration: Yes
Primary sponsor: CSL Behring
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
Date of first enrolment: March 2012
Target sample size: 208
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01545076
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia Austria Belgium Canada Czech Republic Czechia Estonia Finland
France Germany Israel Italy Japan Netherlands Poland 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:

- Definite or probable CIDP according to the European Federation of Neurological
Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.

- An IVIG treatment during the last 8 weeks prior to enrollment.

- Age =18 years.

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

Exclusion Criteria:

- Any polyneuropathy of other causes

- Any other disease (mainly neurological or chronic orthopedic) that has caused
neurological symptoms or may interfere with treatment or outcome assessments

- Severe diseases and conditions that are likely to interfere with evaluation of the
study product or satisfactory conduct of the study

- History of thrombotic episodes within the 2 years prior to enrolment

- Known allergic or other severe reactions to blood products including intolerability to
previous IVIG



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Polyradiculoneuropathy
Intervention(s)
Biological: IgPro10
Biological: IgPro20 (high dose)
Biological: IgPro20 (low dose)
Biological: Placebo
Primary Outcome(s)
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period [Time Frame: Up to 25 weeks]
Secondary Outcome(s)
Change in INCAT During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]
Change in INCAT During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]
Change in Mean Grip Strength During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]
Change in MRC Sum Score During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]
Change in R-ODS During IgPro10 Re-stabilization Therapy [Time Frame: Reference visit and up to 13 weeks]
Change in R-ODS During IgPro10 Rescue Therapy [Time Frame: Before first rescue IgPro10 infusion and up to 13 weeks]
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period [Time Frame: Baseline and up to 25 weeks]
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy [Time Frame: Up to 13 weeks]
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy [Time Frame: Up to 13 weeks]
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period [Time Frame: Up to 28 weeks]
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy [Time Frame: Up to 13 weeks]
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy [Time Frame: Up to 13 weeks]
Number of Subjects With Adverse Events During the SC Treatment Period [Time Frame: Up to 28 weeks]
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy [Time Frame: Up to 13 weeks]
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy [Time Frame: Up to 13 weeks]
Percentage of Subjects With Adverse Events During the SC Treatment Period [Time Frame: Up to 28 weeks]
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period [Time Frame: Up to 25 weeks]
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy [Time Frame: Up to 13 weeks]
Time to Improvement During IgPro10 Re-stabilization Therapy [Time Frame: Up to 13 weeks]
Secondary ID(s)
IgPro20_3003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
ICON Clinical Research
Ethics review
Results
Results available: Yes
Date Posted: 05/07/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01545076
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