Trials Sponsors Conditions Drugs Pricing

Conditions

Myasthenia Gravis Exacerbations

Outcome Measures

Primary Outcomes (1)

Change in Quantitative Myasthenia Gravis (QMG) Scale Score
Mean Change in Quantitative Myasthenia Gravis (QMG) Scale Score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG Scale are 0 and 39, respectively, and a higher score means a worse outcome.
From Baseline (Day 0) to Day 14

Secondary Outcomes (3)

Percentage of Subjects With Clinical Improvement Assessed by QMG
Baseline (Day 0) to Day 14
Percentage of Subjects With Clinical Improvement Assessed by MG-Activities of Daily Living (MG-ADL) Scale
Baseline (Day 0) to Day 14
Percentage of Subjects With Clinical Improvement Assessed by the MG Composite
Baseline (Day 0) to Day 14

Study Arms (1)

IGIV-C Treatment

EXPERIMENTAL

In this arm, subjects with myasthenia gravis exacerbations were treated with an IV dose of 2 g/kg of IGIV-C, which was administered over 2 consecutive days at a dose of 1 g/kg per day.

Biological: IGIV-C

Interventions

IGIV-CBiological

An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day.

IGIV-C Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Grifols Therapeutics LLC
Industrylead

Study Sites (31)

Hospital Italiano

Buenos Aires, C1181ACH, Argentina

Hospital General de Agudos Dr. J. M.

Buenos Aires, C1221ADC, Argentina

Hospital Cordoba

Córdoba, X5004CDT, Argentina

AZ St Lucas Gent

Ghent, East Flanders, 9000, Belgium

UZ Leuven

Leuven, 3000, Belgium

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Results Point of Contact

Title: Rhonda Griffin
Organization: Grifols Therapeutics LLC

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

49 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

March 2015

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

IGIV-C Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

IGIV-C Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations