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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01545076




Registration number
NCT01545076
Ethics application status
Date submitted
1/03/2012
Date registered
6/03/2012
Date last updated
5/07/2018

Titles & IDs
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
Secondary ID [1] 0 0
IgPro20_3003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammatory Demyelinating Polyneuropathy 0 0
Polyradiculoneuropathy 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
Treatment: Other - IgPro20 (low dose)
Treatment: Other - Placebo
Treatment: Other - IgPro10
Treatment: Other - IgPro20 (high dose)

Experimental: IgPro20 low dose -

Experimental: IgPro20 high dose -

Placebo comparator: Placebo -


Treatment: Other: IgPro20 (low dose)
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:

0.2 g/kg body weight (low dose arm)

Treatment: Other: Placebo
2% human albumin administered by weekly SC infusions during the SC treatment period of the study.

Treatment: Other: IgPro10
10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.

Treatment: Other: IgPro20 (high dose)
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:

0.4 g/kg body weight (high dose arm)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
Timepoint [1] 0 0
Up to 25 weeks
Secondary outcome [1] 0 0
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
Timepoint [1] 0 0
Baseline and up to 25 weeks
Secondary outcome [2] 0 0
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
Timepoint [2] 0 0
Baseline and up to 25 weeks
Secondary outcome [3] 0 0
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
Timepoint [3] 0 0
Baseline and up to 25 weeks
Secondary outcome [4] 0 0
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
Timepoint [4] 0 0
Baseline and up to 25 weeks
Secondary outcome [5] 0 0
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Timepoint [5] 0 0
Up to 25 weeks
Secondary outcome [6] 0 0
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Timepoint [6] 0 0
Up to 28 weeks
Secondary outcome [7] 0 0
Number of Subjects With Adverse Events During the SC Treatment Period
Timepoint [7] 0 0
Up to 28 weeks
Secondary outcome [8] 0 0
Percentage of Subjects With Adverse Events During the SC Treatment Period
Timepoint [8] 0 0
Up to 28 weeks
Secondary outcome [9] 0 0
Time to Improvement During IgPro10 Re-stabilization Therapy
Timepoint [9] 0 0
Up to 13 weeks
Secondary outcome [10] 0 0
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
Timepoint [10] 0 0
Reference visit and up to 13 weeks
Secondary outcome [11] 0 0
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
Timepoint [11] 0 0
Reference visit and up to 13 weeks
Secondary outcome [12] 0 0
Change in R-ODS During IgPro10 Re-stabilization Therapy
Timepoint [12] 0 0
Reference visit and up to 13 weeks
Secondary outcome [13] 0 0
Change in INCAT During IgPro10 Re-stabilization Therapy
Timepoint [13] 0 0
Reference visit and up to 13 weeks
Secondary outcome [14] 0 0
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Timepoint [14] 0 0
Up to 13 weeks
Secondary outcome [15] 0 0
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Timepoint [15] 0 0
Up to 13 weeks
Secondary outcome [16] 0 0
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Timepoint [16] 0 0
Up to 13 weeks
Secondary outcome [17] 0 0
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Timepoint [17] 0 0
Up to 13 weeks
Secondary outcome [18] 0 0
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Timepoint [18] 0 0
Up to 13 weeks
Secondary outcome [19] 0 0
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Timepoint [19] 0 0
Up to 13 weeks
Secondary outcome [20] 0 0
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Timepoint [20] 0 0
Up to 13 weeks
Secondary outcome [21] 0 0
Change in Mean Grip Strength During IgPro10 Rescue Therapy
Timepoint [21] 0 0
Before first rescue IgPro10 infusion and up to 13 weeks
Secondary outcome [22] 0 0
Change in MRC Sum Score During IgPro10 Rescue Therapy
Timepoint [22] 0 0
Before first rescue IgPro10 infusion and up to 13 weeks
Secondary outcome [23] 0 0
Change in R-ODS During IgPro10 Rescue Therapy
Timepoint [23] 0 0
Before first rescue IgPro10 infusion and up to 13 weeks
Secondary outcome [24] 0 0
Change in INCAT During IgPro10 Rescue Therapy
Timepoint [24] 0 0
Before first rescue IgPro10 infusion and up to 13 weeks

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Site Reference 0360017 - Herston
Recruitment hospital [2] 0 0
Site reference 0360011 - Fitzroy
Recruitment hospital [3] 0 0
Site reference 0360008 - Southport
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Southport
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
Edmonton
Country [23] 0 0
Canada
State/province [23] 0 0
Toronto
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czechia
State/province [25] 0 0
Prague
Country [26] 0 0
Estonia
State/province [26] 0 0
Tallinn
Country [27] 0 0
Finland
State/province [27] 0 0
Helsinki
Country [28] 0 0
France
State/province [28] 0 0
Clermont-Ferrand
Country [29] 0 0
France
State/province [29] 0 0
Marseille
Country [30] 0 0
France
State/province [30] 0 0
Nice
Country [31] 0 0
France
State/province [31] 0 0
Pessac
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Bochum
Country [34] 0 0
Germany
State/province [34] 0 0
Duesseldorf
Country [35] 0 0
Germany
State/province [35] 0 0
Essen
Country [36] 0 0
Germany
State/province [36] 0 0
Göttingen
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
Ibbenbueren
Country [39] 0 0
Germany
State/province [39] 0 0
Koeln
Country [40] 0 0
Germany
State/province [40] 0 0
Leipzig
Country [41] 0 0
Germany
State/province [41] 0 0
Potsdam
Country [42] 0 0
Germany
State/province [42] 0 0
Wuerzburg
Country [43] 0 0
Israel
State/province [43] 0 0
Haifa
Country [44] 0 0
Israel
State/province [44] 0 0
Tel Aviv
Country [45] 0 0
Italy
State/province [45] 0 0
Chieti
Country [46] 0 0
Italy
State/province [46] 0 0
Firenze
Country [47] 0 0
Italy
State/province [47] 0 0
Genova
Country [48] 0 0
Italy
State/province [48] 0 0
Milano
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
Country [50] 0 0
Italy
State/province [50] 0 0
Rozzano
Country [51] 0 0
Italy
State/province [51] 0 0
Torino
Country [52] 0 0
Japan
State/province [52] 0 0
Aomori
Country [53] 0 0
Japan
State/province [53] 0 0
Chiba
Country [54] 0 0
Japan
State/province [54] 0 0
Kanagawa
Country [55] 0 0
Japan
State/province [55] 0 0
Matsumoto
Country [56] 0 0
Japan
State/province [56] 0 0
Osaka
Country [57] 0 0
Japan
State/province [57] 0 0
Saitama
Country [58] 0 0
Japan
State/province [58] 0 0
Tokushima
Country [59] 0 0
Japan
State/province [59] 0 0
Tokyo
Country [60] 0 0
Japan
State/province [60] 0 0
Yamaguchi
Country [61] 0 0
Netherlands
State/province [61] 0 0
Amsterdam
Country [62] 0 0
Netherlands
State/province [62] 0 0
Maastricht
Country [63] 0 0
Netherlands
State/province [63] 0 0
Utrecht
Country [64] 0 0
Poland
State/province [64] 0 0
Gdansk
Country [65] 0 0
Poland
State/province [65] 0 0
Lodz
Country [66] 0 0
Poland
State/province [66] 0 0
Lublin
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Sevilla
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ICON Clinical Research
Address [1] 0 0
Country [1] 0 0

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01545076