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A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT02473952
Recruitment Status : Completed
First Posted : June 17, 2015
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
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 Myasthenia Gravis, Generalized
Interventions Drug: IGIV-C
Drug: Placebo
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description

IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.

An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).

IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified

Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).

Placebo

Period Title: Overall Study
Started 30 32
Completed 28 24
Not Completed 2 8
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             0             6
Arm/Group Title IGIV-C Placebo Total
Hide Arm/Group Description

IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.

An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).

IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified

Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 30 32 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 32 participants 62 participants
54.6  (17.06) 48.0  (13.66) 51.2  (15.63)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
<65 years
20
  66.7%
29
  90.6%
49
  79.0%
>=65
10
  33.3%
3
   9.4%
13
  21.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Female
14
  46.7%
19
  59.4%
33
  53.2%
Male
16
  53.3%
13
  40.6%
29
  46.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Hispanic or Latino
2
   6.7%
3
   9.4%
5
   8.1%
Not Hispanic or Latino
28
  93.3%
29
  90.6%
57
  91.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.1%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.1%
1
   1.6%
Black or African American
1
   3.3%
0
   0.0%
1
   1.6%
White
29
  96.7%
30
  93.8%
59
  95.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
North America 11 12 23
Europe 19 20 39
1.Primary Outcome
Title Improvement in Myasthenia Gravis (MG) Symptoms as Measured by the Mean Change in Quantitative Myasthenia Gravis (QMG) Total Score.
Hide Description To measure improvement in MG symptoms by the mean change in QMG total score from Baseline (Week 0) to Week 24 as compared to placebo. Evaluators score 13 individual items (range from 0=best to 3=worst) and the individual scores are added together for the total score (range 0-39). An average 3-point improvement in QMG score indicates clinically meaningful improvement.
Time Frame Baseline (Week 0) to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population consisting of all randomized subjects who received at least 1 dose of study medication.
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description:

IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.

An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).

IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified

Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).

Placebo

Overall Number of Participants Analyzed 30 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.6  (5.11) -2.7  (6.23)
Time Frame Adverse event data were collected from screening through Week 24.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IGIV-C Placebo
Hide Arm/Group Description

IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified.

An initial loading dose of 2 g/kg of body weight will be administered at Baseline (Week 0, Visit 1) followed by maintenance doses of 1 g/kg of body weight administered every third week through Week 21 (Visit 8).

IGIV-C: IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified

Placebo: Sterile 0.9% sodium chloride injection or equivalent. Placebo will be infused at the Baseline/Week 0 Visit (Visit 1) using the same volume as would be required for the IGIV-C loading dose. Subsequent placebo maintenance doses will be matched in volume to the IGIV-C maintenance doses and administered every third week until Week 21 (Visit 8).

Placebo

All-Cause Mortality
IGIV-C Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)      0/32 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IGIV-C Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/30 (16.67%)      4/32 (12.50%)    
Cardiac disorders     
Atrial fibrillation  1  1/30 (3.33%)  1 0/32 (0.00%)  0
Cardiopulmonary failure  1  1/30 (3.33%)  1 0/32 (0.00%)  0
Gastrointestinal disorders     
Haemorrhoids thrombosed  1  1/30 (3.33%)  1 0/32 (0.00%)  0
Infections and infestations     
Pneumonia  1  1/30 (3.33%)  1 0/32 (0.00%)  0
Septic shock  1  1/30 (3.33%)  1 0/32 (0.00%)  0
Injury, poisoning and procedural complications     
Lower limb fracture  1  0/30 (0.00%)  0 1/32 (3.13%)  1
Wrist fracture  1  0/30 (0.00%)  0 1/32 (3.13%)  1
Nervous system disorders     
Myasthenia gravis  1  3/30 (10.00%)  3 1/32 (3.13%)  1
Ischaemic stroke  1  0/30 (0.00%)  0 1/32 (3.13%)  1
Cerebral haemorrhage  1  0/30 (0.00%)  0 1/32 (3.13%)  1
Psychiatric disorders     
Panic attack  1  1/30 (3.33%)  1 0/32 (0.00%)  0
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
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   22/30 (73.33%)      21/32 (65.63%)    
Gastrointestinal disorders     
Diarrhoea  1  3/30 (10.00%)  4 2/32 (6.25%)  2
Nausea  1  3/30 (10.00%)  13 1/32 (3.13%)  1
General disorders     
Chills  1  2/30 (6.67%)  2 0/32 (0.00%)  0
Fatigue  1  2/30 (6.67%)  3 0/32 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  3/30 (10.00%)  3 4/32 (12.50%)  4
Upper respiratory tract infection  1  0/30 (0.00%)  0 3/32 (9.38%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/30 (6.67%)  2 0/32 (0.00%)  0
Back pain  1  2/30 (6.67%)  3 1/32 (3.13%)  1
Neck pain  1  2/30 (6.67%)  2 0/32 (0.00%)  0
Pain in extremity  1  1/30 (3.33%)  1 2/32 (6.25%)  2
Nervous system disorders     
Dizziness  1  2/30 (6.67%)  2 1/32 (3.13%)  1
Headache  1  9/30 (30.00%)  22 4/32 (12.50%)  6
Myasthenia gravis  1  0/30 (0.00%)  0 2/32 (6.25%)  2
Respiratory, thoracic and mediastinal disorders     
Catarrh  1  2/30 (6.67%)  3 0/32 (0.00%)  0
Cough  1  3/30 (10.00%)  4 0/32 (0.00%)  0
Dyspnoea  1  2/30 (6.67%)  2 0/32 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  2/30 (6.67%)  2 1/32 (3.13%)  1
Vascular disorders     
Hypertension  1  3/30 (10.00%)  5 2/32 (6.25%)  3
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
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.
Site may publish results from the study, after providing Sponsor at least thirty days’ notice prior to submitting a manuscript or other materials related to the study to any outside party. At Sponsor’s request, the site will remove any confidential information (other than study results), and incorporate all reasonable comments by Sponsor, or delay publication or presentation for a period of up to 120 days to allow Sponsor to protect its interests in any Sponsor’s Inventions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rhonda Griffin, BSN
Organization: Grifols Therapeutics, LLC
Phone: 919-316-6693
EMail: Rhonda.Griffin@Grifols.com
Layout table for additonal information
Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT02473952     History of Changes
Other Study ID Numbers: GTI1408
First Submitted: June 14, 2015
First Posted: June 17, 2015
Results First Submitted: January 29, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019