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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Grifols Therapeutics Inc.
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT02413580
First received: April 7, 2015
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
This is 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.

Condition Intervention Phase
Myasthenic Crisis
Biological: IGIV-C
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Grifols Therapeutics Inc.:

Primary Outcome Measures:
  • Change in quantitative myasthenia gravis (QMG) scale score [ Time Frame: From Baseline (Day 0) to Day 14 ]

Secondary Outcome Measures:
  • 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) [ 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 ]

Estimated Enrollment: 50
Study Start Date: March 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGIV-C Treatment
An IV dose of 2 g/kg of IGIV-C will be administered in subjects with myasthenia gravis exacerbations.
Biological: IGIV-C
an IV dose of 2 g/kg of IGIV-C will be administered as 2 doses of 1 g/kg on two consecutive days

Detailed Description:
The study consists 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 is up to 28 ± 2 days. Approximately 50 subjects, ages 18 or greater, are 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 meet 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 have 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 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 suffer 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02413580

Contacts
Contact: Sandra Camprubi, PhD sandra.camprubi@grifols.com

Locations
Belgium
AZ St Lucas Gent Recruiting
Ghent, East Flanders, Belgium, 9000
Contact: Kathy De Koning       secretariaat.neurologie@azstlucas.be   
Principal Investigator: Jan De Bleecker         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ann Dhondt       cardiovpk.kn@vzwgo.be   
Principal Investigator: Philip Van Damme         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Denise Hulley       Denise.Hulley@lhsc.on.ca   
Contact: Wilma Koopman         
Principal Investigator: Michael Nicolle         
University Health Network (UHN) - Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eduardo Ng       Eduardo.Ng@uhn.ca   
Principal Investigator: Vera Bril         
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Victoria Eon       victoria.c.eon@gmail.com   
Principal Investigator: Angela Genge         
Czech Republic
Fakultni nemocnice Brno, Neurologicka klinika Recruiting
Brno, Czech Republic
Contact: Stanislava Toncrova       stanislava.toncrova@fnbrno.cz   
Principal Investigator: Josef Bednarik         
Fakultni nemocnice Ostrava, Neurologická klinika Recruiting
Ostrava, Czech Republic, 70800
Contact: Petr Hon       petr.hon@fnspo.cz   
Principal Investigator: Petr Hon         
Vseobecna fakultni nemocnice v Praze Recruiting
Prague, Czech Republic, 12808
Contact: Michaela Tyblova       mtyblova@seznam.cz   
Contact       myadisp@vfn.cz   
Principal Investigator: Michaela Tyblova         
Estonia
East Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10138
Contact: Toomas Toomsoo       toomas.toomsoo@itk.ee   
Principal Investigator: Toomas Toomsoo         
France
Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact: Julie Moutarde       moutarde.j@chu-nice.fr   
Principal Investigator: Jean Pouget         
CHU de Toulouse - Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Aurore Naudin       naudin.a@chu-toulouse.fr   
Principal Investigator: David Brassat         
Hungary
Pest Megyei Flor Ferenc Korhaz Recruiting
Kistarcsa, Hungary, 2143
Contact: Gyula Pánzél       panczel@florhosp.hu   
Principal Investigator: Gyula Pánzél         
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház Recruiting
Nyíregyháza, Hungary
Contact: Edit Muskoczki       muskoczki@josa.hu   
Principal Investigator: Peter Dioszeghy         
University of Szeged, Faculty of Medicine Recruiting
Szeged, Hungary, 4400
Contact: Laszlo Vecsei       vecsei@nepsy.szoteu-szeged.hu   
Principal Investigator: Laszlo Vecsei         
Zala Megyei Korhaz Recruiting
Zalaegerszeg, Hungary, 8900
Contact: Janos Nikl       drnikl@zmkorhaz.hu   
Principal Investigator: Janos Nikl         
Latvia
Riga East Clinical University Hospital Recruiting
Riga, Latvia, LV-1038
Contact: Guntis Karellis       guntis.karelis@gmail.com   
Principal Investigator: Guntis Karellis         
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV1002
Contact: Andrejs Millers       andrejs@stradini.lv   
Principal Investigator: Andrejs Millers         
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland
Contact: Magdalena Chylinska       madziana500@wp.pl   
Principal Investigator: Malgorzata Bilinska         
Romania
Institutul Clinic Fundeni Recruiting
Bucuresti, Romania, 22328
Contact: Crisanda Vilciu       crisandavalciu@yahoo.com   
Principal Investigator: Crisanda Vilciu         
Spitalul Clinic Judetean de Urgenta Targu-Mures Recruiting
Targu Mures, Romania, RO540136
Contact: Rodica Ioana Balasa       iipascu@redatronic.ro   
Principal Investigator: Rodica Ioana Balasa         
Russian Federation
State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko Recruiting
Nizhny Novgorod, Russian Federation, 603126
Contact: Alexander Gustov       gustovav@mail.ru   
Principal Investigator: Alexander Gustov         
- Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2 Recruiting
Saint Petersburg, Russian Federation, 357538
Contact: Dmitry Rudenko       dmrud_h2@mail.ru   
Principal Investigator: Fatima Stuchevskaya         
State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital. V.D.Seredavin Recruiting
Samara, Russian Federation, 443095
Contact: Nadezhda Kuznetsova       nadiv35@mail.ru   
Principal Investigator: Irina Poverennova         
South Africa
Groote Schuur Hospital, Recruiting
Cape Town, South Africa
Contact: Fiona Drummond       fionad@zsd.co.za   
Principal Investigator: Jeannine Heckmann         
Sponsors and Collaborators
Grifols Therapeutics Inc.
  More Information

Responsible Party: Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02413580     History of Changes
Other Study ID Numbers: GTI1305 
Study First Received: April 7, 2015
Last Updated: July 25, 2016

Additional relevant MeSH terms:
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 20, 2017