A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02413580
• Date of registration: 07/04/2015
• Prospective Registration: No
• Primary sponsor: Grifols Therapeutics LLC
• Public title: A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations
• Scientific title: A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations
• Date of first enrolment: March 2015
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02413580
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Canada, Czech Republic, Czechia, Estonia, France, Hungary, Latvia, Poland, Romania, Russian Federation, South Africa

Key inclusion & exclusion criteria

Inclusion Criteria:

- Was male or female aged =18 years.

- Subjects must be willing and able to provide written informed consent (if applicable,
a legally authorized representative may provide informed consent on behalf of the
subject).

- Subjects who met the clinical criteria for diagnosis of MG with an exacerbation
defined as worsening of MG symptoms as defined by an Myasthenia Gravis Foundation of
America (MGFA) classification IVb or V.

- Subjects on long-term (8 weeks) corticosteroid treatment for MG.

- Female subjects of child-bearing potential must have a negative test for pregnancy
(human chorionic gonadotropin [HCG]-based assay).

- Subjects must be willing to comply with all aspects of the clinical trial protocol,
including blood sampling and long-term storage of extra samples, for the entire
duration of the study.

Exclusion Criteria:

- Subjects who had received immune globulin treatment given by IV, subcutaneous or
intramuscular route within the last 30 days.

- Subjects with documentation of a lack of clinical response to intravenous
immunoglobulin (IVIg) therapy for MG.

- Subjects documented positive for antibodies directed against Muscle specific kinase
(MuSK).

- Subjects with corticosteroid (CS) treatment initiated within the last 8 weeks or
modified within the last 2 weeks.

- Subjects with plasma exchange (PLEX) within the last 30 days.

- Subjects with MG exacerbation attributable to change in medication or infection or
evident infection as defined by, but not limited to, the presence of at least one of
the following diagnostic features: 1) axillary temperature =38°C, 2) positive blood
culture of infective microorganism, 3) white blood cell count >12×10^9/L and
differential white blood cell count of >10% band neutrophils (>1.2×10^9/L), and 4)
pulmonary infiltrate with consolidation on chest X-ray. Alternatively, other signs and
symptoms may be considered for the diagnosis of evident infection according to the
Investigator's judgement.

- Subjects with inadequate venous access.

- Subjects with a history of anaphylactic reactions or severe reactions to any
blood-derived product.

- Subjects with a history of intolerance to any component of the investigational
products.

- Subjects with a documented diagnosis of thrombotic complications to polyclonal IVIG
therapy in the past.

- Subjects with a history of recent (within the last year) myocardial infarction, stroke
or uncontrolled hypertension.

- Subjects who suffered from uncontrolled congestive heart failure, embolism or
documented electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial
fibrillation.

- Subjects with current known hyperviscosity or hypercoagulable state.

- Subjects currently receiving anti-coagulation therapy.

- Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the
12 months preceding the Baseline Visit.

- Subjects currently receiving, or having received within 3 months prior to the Baseline
Visit, any investigational medicinal product or device.

- Subjects with a known Immunoglobulin A (IgA) deficiency and anti-IgA serum antibodies.

- Subjects with renal impairment (i.e., serum creatinine exceeds more than 1.5 times the
upper limit of normal [ULN] for the expected normal range for the testing laboratory).

- Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
levels exceeding more than 2.5 times the ULN for the expected normal range for the
testing laboratory.

- Subjects with haemoglobin levels <9 g/dL.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis Exacerbations

Intervention(s)

Biological: IGIV-C

Primary Outcome(s)

Change in Quantitative Myasthenia Gravis (QMG) Scale Score [Time Frame: From Baseline (Day 0) to Day 14]

Secondary Outcome(s)

Percentage of Subjects With Clinical Improvement Assessed by QMG [Time Frame: Baseline (Day 0) to Day 14]

Percentage of Subjects With Clinical Improvement Assessed by MG-Activities of Daily Living (MG-ADL) Scale [Time Frame: Baseline (Day 0) to Day 14]

Percentage of Subjects With Clinical Improvement Assessed by the MG Composite [Time Frame: Baseline (Day 0) to Day 14]

Secondary ID(s)

GTI1305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02413580