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

NCT ID: NCT02413580

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-04-30

Brief Summary

This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.

Detailed Description

The study consisted of a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments. The total duration of study participation for each subject was up to 28 ± 2 days. Approximately 50 subjects, ages 18 or greater, were planned to be enrolled in the study and receive a single, total dose of 2 g/kg of IGIV-C over 2 consecutive days (dose of 1 g/kg per day) across multiple centers in Argentina, Canada, Europe, and South Africa.

Conditions

Myasthenia Gravis Exacerbations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGIV-C Treatment

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.

Group Type: EXPERIMENTAL

IGIV-C

Intervention Type: BIOLOGICAL

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.

Interventions

IGIV-C

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Therapeutics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Italiano

Buenos Aires, , Argentina

Hospital General de Agudos Dr. J. M.

Buenos Aires, , Argentina

Hospital Cordoba

Córdoba, , Argentina

AZ St Lucas Gent

Ghent, East Flanders, Belgium

UZ Leuven

Leuven, , Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

London Health Sciences Centre

London, Ontario, Canada

University Health Network (UHN) - Toronto General Hospital

Toronto, Ontario, Canada

Fakultni nemocnice Brno, Neurologicka klinika

Brno, , Czechia

Fakultni nemocnice Ostrava, Neurologická klinika

Ostrava, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

East Tallinn Central Hospital

Tallinn, , Estonia

Hopital Neurologique Pierre Wertheimer

Bron, Lyon, France

Hôpital Albert Michallon

Grenoble, , France

Hopital Roger Salengro

Lille, , France

Hôpital de la Timone

Marseille, , France

Hôpital Hautepierre Strasbourg

Strasbourg, , France

CHU de Toulouse - Hôpital Purpan

Toulouse, , France

Jahn Ferenc Del-Pesti Korhaz

Budapest, , Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

Nyíregyháza, , Hungary

University of Szeged, Faculty of Medicine

Szeged, , Hungary

Zala Megyei Korhaz

Zalaegerszeg, , Hungary

Riga East Clinical University Hospital

Riga, , Latvia

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Institutul Clinic Fundeni

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta Targu-Mures

Târgu Mureş, , Romania

State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko

Nizhny Novgorod, , Russia

Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2

Saint Petersburg, , Russia

State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital. V.D.Seredavin

Samara, , Russia

Groote Schuur Hospital,

Cape Town, , South Africa

Countries

Argentina; Belgium; Canada; Czechia; Estonia; France; Hungary; Latvia; Poland; Romania; Russia; South Africa

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GTI1305

Identifier Type: -

Identifier Source: org_study_id