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Trial record 3 of 6 for:    "Chronic Inflammatory Demyelinating Polyneuritis" | "Immunoglobulin G"

Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (ICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00220740
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 10, 2015
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Interventions Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
Drug: Albumin (Human) 25%, United States Pharmacopeia (USP)
Enrollment 117
Recruitment Details The study was conducted at 31 study centers in USA, Poland, Argentina, Czech Republic, Canada, Mexico, Italy, Israel, Germany, and Serbia.
Pre-assignment Details  
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description 2 g/kg loading dose, followed by 1 g/kg maintenance dose .1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
Period Title: Efficacy Period
Started 59 58
Completed 33 12
Not Completed 26 46
Reason Not Completed
Entered rescue treatment with placebo             23             0
Adverse Event             1             1
Withdrawal by Subject             1             0
Protocol Violation             1             0
Entered Rescue Treatment with IGIV-C             0             45
Period Title: Rescue Treatment
Started 45 [1] 23 [1]
Completed 26 5
Not Completed 19 18
[1]
Only the subjects who failed the treatment in the Efficacy period entered the Rescue period.
Period Title: Withdrawal Period
Started 43 [1] 31 [1]
Completed 37 16
Not Completed 6 15
[1]
The subjects who were success in Efficacy or Rescue Period were re-randomized to Withdrawal period.
Arm/Group Title IGIV-C Placebo Total
Hide Arm/Group Description 2 g/kg loading dose, followed by 1 g/kg maintenance dose .1% albumin, 2 g/kg loading dose, followed by 1 g/kg maintenance dose Total of all reporting groups
Overall Number of Baseline Participants 59 58 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
<=18 years
0
   0.0%
1
   1.7%
1
   0.9%
Between 18 and 65 years
44
  74.6%
40
  69.0%
84
  71.8%
>=65 years
15
  25.4%
17
  29.3%
32
  27.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 58 participants 117 participants
49.9  (17.31) 53.3  (15.63) 51.6  (16.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Female
28
  47.5%
12
  20.7%
40
  34.2%
Male
31
  52.5%
46
  79.3%
77
  65.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
United States 4 2 6
Czech Republic 7 6 13
Mexico 3 5 8
Canada 1 1 2
Argentina 8 7 15
Poland 15 15 30
Israel 8 7 15
Germany 2 3 5
Italy 6 6 12
Macedonia, The Former Yugoslav Republic of 5 6 11
Baseline INCAT Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 59 participants 58 participants 117 participants
Total Overall Disability Score 4.2  (1.4) 4.1  (1.5) 4.2  (1.4)
Upper Extremity Disability Score 2.3  (1.0) 2.1  (1.0) 2.2  (1.0)
Lower Extremity Disability Score 1.9  (0.8) 1.9  (1.1) 1.9  (0.9)
[1]
Measure Description:

Baseline INCAT score for all subjects and subgroups for Efficacy Period, Rescue treatment, and Randomized Withdrawal Period (ITT population) Measurements are reported in Inflammatory Neuropathy Case And Treatment (INCAT) scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.

INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.

INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help

1.Primary Outcome
Title Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period
Hide Description

The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.

Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.

INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.

INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat Population was defined as all randomized subjects. This population was the primary efficacy population to be analyzed.
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of responders
54.2 20.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV-C, Placebo
Comments The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period
Hide Description Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description:
2 g/kg loading dose, followed by 1 g/kg maintenance dose
.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: Millivolts
0.69  (1.856) 0.47  (2.291)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV-C, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.542
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Mean Change in Grip Strength During the Efficacy Period
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description:
2 g/kg loading dose, followed by 1 g/kg maintenance dose
.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: kilopascal
Dominant hand (IGIV-C n=57, Placebo n=58) 13.175  (19.2935) 1.489  (15.5742)
Non-dominant hand (IGIV-C n=58, Placebo n=58) 13.316  (17.3526) 4.261  (14.8959)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IGIV-C, Placebo
Comments Dominant hand
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IGIV-C, Placebo
Comments Non-dominant hand
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
In the Randomized Withdrawal Period, 43 subjects were randomized to IGIV-C, but only 31 out of the 41 subjects were prior IGIV-C responders or rescue successes. Similarly, 31 subjects were randomized to Placebo, but only 26 out of the 31 subjects were prior IGIV-C responders or rescue successes.
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description:
2 g/kg loading dose, followed by 1 g/kg maintenance dose
.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
Overall Number of Participants Analyzed 31 26
Mean (Standard Deviation)
Unit of Measure: weeks
21.89  (6.181) 16.56  (8.543)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description

2 g/kg loading dose, followed by 1 g/kg maintenance dose.

A total of 113 subjects were exposed to IGIV-C across all three treatments/periods.

.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose.

A total of 95 subjects were exposed to Placebo across all three treatments/periods.

All-Cause Mortality
IGIV-C Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IGIV-C Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/113 (5.31%)      8/95 (8.42%)    
Cardiac disorders     
Palpitations  1/113 (0.88%)  1 0/95 (0.00%)  0
Gastrointestinal disorders     
Vomiting  1/113 (0.88%)  1 0/95 (0.00%)  0
General disorders     
Pyrexia  1/113 (0.88%)  1 0/95 (0.00%)  0
Infections and infestations     
Bronchopneumonia  1/113 (0.88%)  1 0/95 (0.00%)  0
Gastroenteritis viral  0/113 (0.00%)  0 1/95 (1.05%)  1
Investigations     
Medical observation (for asthma)  0/113 (0.00%)  0 1/95 (1.05%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  0/113 (0.00%)  0 1/95 (1.05%)  1
Back pain  0/113 (0.00%)  0 1/95 (1.05%)  1
Nervous system disorders     
Dizziness  1/113 (0.88%)  1 0/95 (0.00%)  0
Headache  2/113 (1.77%)  2 0/95 (0.00%)  0
Demyelinating polyneuropathy  0/113 (0.00%)  0 1/95 (1.05%)  1
Cerebrovascular accident  0/113 (0.00%)  0 1/95 (1.05%)  1
CIDP (relapse)  0/113 (0.00%)  0 1/95 (1.05%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy  0/113 (0.00%)  0 1/95 (1.05%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1/113 (0.88%)  1 0/95 (0.00%)  0
Dyspnea  1/113 (0.88%)  1 0/95 (0.00%)  0
Asthma  0/113 (0.00%)  0 1/95 (1.05%)  1
Vascular disorders     
Deep vein thrombosis  0/113 (0.00%)  0 1/95 (1.05%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IGIV-C Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   81/113 (71.68%)      25/95 (26.32%)    
Gastrointestinal disorders     
Nausea  7/113 (6.19%)  9 3/95 (3.16%)  3
General disorders     
Pyrexia  14/113 (12.39%)  26 0/95 (0.00%)  0
Asthenia  9/113 (7.96%)  10 3/95 (3.16%)  4
Chills  9/113 (7.96%)  10 0/95 (0.00%)  0
Infections and infestations     
Influenza  6/113 (5.31%)  6 2/95 (2.11%)  2
Musculoskeletal and connective tissue disorders     
Back pain  8/113 (7.08%)  9 3/95 (3.16%)  3
Arthralgia  8/113 (7.08%)  11 1/95 (1.05%)  1
Nervous system disorders     
Headache  34/113 (30.09%)  55 8/95 (8.42%)  15
Dizziness  6/113 (5.31%)  6 1/95 (1.05%)  1
Skin and subcutaneous tissue disorders     
Rash  8/113 (7.08%)  13 1/95 (1.05%)  1
Vascular disorders     
Hypertension  10/113 (8.85%)  20 4/95 (4.21%)  6
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.
The investigator must send a draft manuscript of the publication or abstract to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the investigator(s), the contents of the publication will be discussed in order to find a solution that satisfies both parties.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry Li
Organization: Grifols Therapeutics
Phone: 1-800-520-2807
EMail: henry.li@grifols.com
Layout table for additonal information
Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT00220740     History of Changes
Other Study ID Numbers: 100538
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: September 24, 2009
Results First Posted: September 10, 2015
Last Update Posted: March 23, 2016