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Trial record 1 of 22 for:    "Chronic Inflammatory Demyelinating Polyneuropathy" | "Immunoglobulins, Intravenous"
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Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy

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ClinicalTrials.gov Identifier: NCT01184846
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : April 4, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Inflammatory Demyelinating Polyneuropathy
Intervention Biological: 10% liquid formulation of human immunoglobulin
Enrollment 31
Recruitment Details This multicenter study enrolled subjects at 13 participating study centers in 5 countries in Europe.
Pre-assignment Details

A total of 31 subjects were screened and 28 were eligible.

  • Intravenous immunoglobulin (IVIG)-untreated subjects: screening took place up to 3 weeks prior to the first IgPro10 infusion
  • IVIG-pretreated subjects: Screening took place at any time at or after the last dose of pre-study IVIG (up to 10 weeks prior to the first IgPro10 infusion)
Arm/Group Title IgPro10
Hide Arm/Group Description 10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Period Title: Overall Study
Started 28
Completed 25
Not Completed 3
Reason Not Completed
Adverse Event             2
Insufficient response             1
Arm/Group Title IgPro10
Hide Arm/Group Description 10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
58.7  (14.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
10
  35.7%
Male
18
  64.3%
Previous IVIG treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
IVIG-pretreated subjects 13
IVIG-untreated subjects 15
1.Primary Outcome
Title Responder Rate
Hide Description

Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score.

Responders were defined as those subjects who: 1) demonstrated a “clinically meaningful improvement” between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with “clinically meaningful improvement” at the last study visit.

"Clinically meaningful improvement” was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0.

Time Frame 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. The valid cases set (VCS) consists of all FAS subjects without any major protocol deviation (ie, the subjects who participated in the study as intended).
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
FAS (n = 28)
60.7
(42.409 to 76.434)
VCS (n = 22)
63.6
(42.952 to 80.267)
2.Secondary Outcome
Title Change in Adjusted INCAT Score
Hide Description

The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.

The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates ‘no upper limb problems’ and arm = 5 indicates ‘inability to use either arm for any purposeful movement’, and leg = 0 indicates ‘walking not affected’, and leg = 5 indicates ‘restricted to wheelchair, unable to stand and walk a few steps with help’). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.

Time Frame Up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
All subjects; n = 28
-1.3
(-2.0 to -0.5)
IVIG-pretreated; n = 13
-2.0
(-2.5 to -1.0)
IVIG-untreated; n = 15
-1.0
(-2.0 to 0.0)
IVIG-pretreated (last IVIG to completion); n = 13
-2.0
(-2.5 to -1.0)
3.Secondary Outcome
Title Change in Maximum Grip Strength
Hide Description Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.
Time Frame Up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Mean (95% Confidence Interval)
Unit of Measure: kPa
All subjects; n = 28
9.0
(-1.0 to 22.3)
IVIG-pretreated; n = 13
8.0
(-5.0 to 25.0)
IVIG-untreated; n = 15
9.0
(-6.0 to 35.0)
IVIG-pretreated (last IVIG to completion); n = 13
-1.5
(-12.5 to 14.5)
4.Secondary Outcome
Title Change in Medical Research Council Sum Scale (MRC)
Hide Description

The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.

The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline.

Time Frame Up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
All subjects; n = 28
6.5
(4.0 to 9.5)
IVIG-pretreated; n = 13
6.0
(2.5 to 10.0)
IVIG-untreated; n = 15
7.0
(3.0 to 12.5)
IVIG-pretreated (last IVIG to completion); n = 13
1.0
(-2.5 to 4.5)
5.Secondary Outcome
Title Immunoglobulin G (IgG) Level
Hide Description [Not Specified]
Time Frame At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement.
Arm/Group Title IgPro10 - Before Infusion IgPro10 - After Infusion
Hide Arm/Group Description:
IgG levels were determined before infusion with IgPro10.
IgG levels were determined after infusion with IgPro10.
Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: mg/dL
At baseline (n = 28 and 27, respectively) 1259.5  (377.47) 2859.2  (846.83)
At Week 7 (n = 26) 1750.0  (313.73) 3228.8  (803.22)
At Week 13 (n = 25) 1733.2  (353.00) 3496.7  (575.11)
At Week 19 (n = 25 and 24, respectively) 1684.6  (306.62) 3386.1  (567.05)
At Completion (n = 0 and 28 respectively) NA [1]   (NA) 1943.6  (465.85)
[1]
There was no IgPro10 infusion at the completion visit. Thus, the IgG level measured at the completion visit represents the IgG level 3 weeks after the last infusion (at week 19) or at early discontinuation.
6.Secondary Outcome
Title Frequency of Adverse Events (AEs)
Hide Description Overall rate of AEs per infusion.
Time Frame For the duration of the study, up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety data set (SDS) comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
259
Measure Type: Number
Unit of Measure: AE rate per infusion
0.417
7.Secondary Outcome
Title Severity of AEs Per Infusion
Hide Description

The severity of each AE was to be graded by the investigator as follows:

  • Mild: Symptoms were easily tolerated and there was no interference with daily activities.
  • Moderate: Discomfort enough to cause some interference with daily activities.
  • Severe: Incapacitating with inability to work or do usual activity.
Time Frame For the duration of the study, up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
259
Measure Type: Number
Unit of Measure: AE rate per infusion
Mild AE 0.266
Moderate AE 0.143
Severe AE 0.008
8.Secondary Outcome
Title Severity of AEs Per Subject
Hide Description

The severity of each AE was to be graded by the investigator as follows:

  • Mild: Symptoms were easily tolerated and there was no interference with daily activities.
  • Moderate: Discomfort enough to cause some interference with daily activities.
  • Severe: Incapacitating with inability to work or do usual activity.
Time Frame 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of subjects
Mild AE 67.9
Moderate AE 46.4
Severe AE 7.1
9.Secondary Outcome
Title Relatedness of AEs Per Infusion
Hide Description The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.
Time Frame For the duration of the study, up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
259
Measure Type: Number
Unit of Measure: AE rate per infusion
Not Related 0.201
Unlikely Related 0.027
Possibly Related 0.081
Probably Related 0.042
Related 0.066
10.Secondary Outcome
Title Relatedness of AEs Per Subject
Hide Description The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.
Time Frame For the duration of the study, up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of subjects
Not Related 60.7
Unlikely Related 14.3
Possibly Related 39.3
Probably Related 25.0
Related 25.0
11.Secondary Outcome
Title Mean Change in Systolic and Diastolic Blood Pressure During Infusion
Hide Description Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.
Time Frame At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic BP mean value of mean change 1.03  (7.62)
Diastolic BP mean value of mean change 0.99  (7.46)
12.Secondary Outcome
Title Mean Change in Pulse Rate During Infusion
Hide Description Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.
Time Frame At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.14  (3.58)
13.Secondary Outcome
Title Mean Change in Body Temperature During Infusion
Hide Description Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.
Time Frame At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: °C
0.06  (0.17)
14.Secondary Outcome
Title Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.
Hide Description Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.
Time Frame At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
The SDS comprised all subjects treated with the study drug.
Arm/Group Title IgPro10
Hide Arm/Group Description:
10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
4
Time Frame For the duration of the study, up to 34 weeks.
Adverse Event Reporting Description Only AEs starting at or after the first study drug infusion are included. The safety data set (SDS) comprised all subjects treated with the study drug.
 
Arm/Group Title IgPro10
Hide Arm/Group Description 10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
All-Cause Mortality
IgPro10
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IgPro10
Affected / at Risk (%) # Events
Total   4/28 (14.29%)    
Blood and lymphatic system disorders   
Haemolysis  1  2/28 (7.14%)  2
Infections and infestations   
Diverticulitis  1  1/28 (3.57%)  1
Nervous system disorders   
Chronic inflammatory demyelinating polyradiculoneuropathy  1  1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IgPro10
Affected / at Risk (%) # Events
Total   22/28 (78.57%)    
Blood and lymphatic system disorders   
Leukopenia  1  4/28 (14.29%)  4
Gastrointestinal disorders   
Nausea  1  3/28 (10.71%)  3
General disorders   
Asthenia  1  4/28 (14.29%)  4
Influenza-like illness  1  2/28 (7.14%)  2
Injury, poisoning and procedural complications   
Contusion  1  2/28 (7.14%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/28 (7.14%)  3
Pain in extremity  1  6/28 (21.43%)  7
Nervous system disorders   
Headache  1  9/28 (32.14%)  20
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  2/28 (7.14%)  2
Skin and subcutaneous tissue disorders   
Rash  1  2/28 (7.14%)  2
Vascular disorders   
Hypertension  1  4/28 (14.29%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
Phone: Use email contact
EMail: clinicaltrials@cslbehring.com
Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01184846     History of Changes
Other Study ID Numbers: IgPro10_3001
1504 ( Other Identifier: CSL Behring )
2009-017672-24 ( EudraCT Number )
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: January 30, 2013
Results First Posted: April 4, 2013
Last Update Posted: September 6, 2013