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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis, Generalized Drug: IGIV-C Drug: Placebo Phase 2

Detailed Description:

The primary objective is to evaluate the efficacy of IGIV-C in subjects with generalized myasthenia gravis (MG) on standard of care treatment at study entry in terms of improvement in MG symptoms as measured by the mean change in Quantitative Myasthenia Gravis (QMG) score from Baseline (Week 0) to Week 24 as compared to placebo.

The safety objective of this study is to evaluate the safety and tolerability of IGIV-C loading dose of 2 g/kg followed by 7 maintenance dosages of 1 g/kg every 3 weeks through Week 21 in subjects with MG.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis
Actual Study Start Date : August 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IGIV-C

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).

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

Placebo Comparator: Placebo
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).
Drug: Placebo



Primary Outcome Measures :
  1. Improvement in Myasthenia Gravis (MG) Symptoms as Measured by the Mean Change in Quantitative Myasthenia Gravis (QMG) Total Score. [ Time Frame: Baseline (Week 0) to Week 24 ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anti-acetylcholine receptor (AChR) antibody positive
  • Confirmed diagnosis of generalized myasthenia gravis (MG).
  • Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa inclusive at Screening.
  • QMG >= 10 at Screening. Note: Subjects who only have a history of ocular MG may not enroll.
  • Receiving standard of care MG treatment at a stable dose consisting of any one of the following for the time intervals delineated below (time intervals apply to medications and maintenance of stable dose level):

    1. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening and no immunosuppressants
    2. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR only one of the following:

      1. Prednisone (up to 60 mg/day or equivalent) for at least 2 months prior to Screening, OR
      2. Azathioprine for at least 6 months prior to Screening, OR
      3. Mycophenolate mofetil for at least 6 months prior to Screening, OR
      4. Methotrexate for at least 6 months prior to Screening, OR
      5. Cyclosporine or tacrolimus for at least 3 months prior to Screening
    3. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening AND/OR prednisone (up to 60 mg/day or equivalent) for at least one month prior to Screening and only one of the following:

      1. Azathioprine for at least 6 months prior to Screening, OR
      2. Mycophenolate mofetil for at least 6 months prior to Screening, OR
      3. Methotrexate for at least 6 months prior to Screening, OR
      4. Cyclosporine or tacrolimus for at least 3 months prior to Screening

Exclusion Criteria:

  • Have received cyclophosphamide or any other immunosuppressive agent apart from the ones allowed per inclusion criteria within the past 6 months
  • Any change in MG treatment regimen between Screening (Week -3, Visit 0) and Baseline (Week 0, Visit 1)
  • Greater than two point change in QMG score, increased or decreased, between Screening (Week -3, Visit 0) and Baseline (Week 0, Visit 1)
  • Any episode of myasthenic crisis in the one month prior to Screening
  • Evidence of malignancy within the past 5 years (non-melanoma skin cancer, carcinoma in situ of cervix is allowed) or thymoma potentially requiring surgical intervention during the course of the trial (intent to perform thymectomy)
  • Thymectomy within the preceding 6 months
  • Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation within the past 12 months
  • Have received immune globulin (Ig) treatment given by intravenous (IV), subcutaneous, or intramuscular route within the last 3 months
  • Current known hyperviscosity or hypercoagulable state
  • Currently receiving anti-coagulation therapy (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate, rivaroxaban, edoxaban, and apixaban], parenteral anticoagulants [e.g., fondaparinux]). Note that oral anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlodipine)
  • Documented diagnosis of thrombotic complications to polyclonal intravenous immunoglobulin (IVIg) therapy in the past
  • History of recent (within the last year) myocardial infarction or stroke
  • Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation
  • History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Screening/Week -3 (Visit 0)
  • Plasma exchange (PLEX) performed within the last 3 months
  • 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).
  • Hemoglobin levels less than 9 g per dL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473952


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Locations
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United States, Arizona
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, United States, 85018
United States, California
University of California-Irvine
Orange, California, United States, 92868
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
United States, New Jersey
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43220
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05405
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Belgium
UZ Leuven
Leuven, Belgium, 3000
Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
University Health Network (UHN) - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Czechia
Fakultni nemocnice Brno, Dept of Neurologicka klinika
Brno, Czechia, 625 00
Fakultni nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Estonia
East Tallinn Central Hospital
Tallinn, Estonia, 10138
France
CHU Nice - Hôpital de l'Archet 1, Ctre de Réf Maladies Neuromusculaires et SLA
Nice cedex 3, Alpes Maritimes, France, 6202
CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique
Strasbourg cedex, Bas Rhin, France, 67091
CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale
Toulouse cedex 9, Haute Garonne, France, 31059
Hopital Neurologique Pierre Wertheimer, Neuro-musculaire - Electromyographie
Bron cedex, Rhone, France, 69677
Germany
Universitaetsklinikum Regensburg, Parent
Regensburg, Bayern, Germany, 93053
Universitaetsmedizin Göttingen, Parent
Göttingen, Niedersachsen, Germany, 37075
Universitaetsklinikum Koeln, Neurologie und Psychiatrie
Koeln, Nordrhein Westfalen, Germany, 50937
Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie
Halle, Sachsen Anhalt, Germany, 6120
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Sachsen, Germany, 1307
Universitaetsklinikum Jena, Klinik fuer Neurologie
Jena, Thueringen, Germany, 7747
Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fuer Neurologie
Hamburg, Germany, 20246
Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly
Budapest, Hungary, 1204
Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly
Kistarcsa, Hungary, 2143
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 6725
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Poland
Uniwersyteckie Centrum Kliniczne, Dept of Neurology
Gdansk, Poland, 80-952
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow, Poland, 31-505
III Szpital Miejski w Lodzi im. Dr K. Jonschera
Lodz, Poland, 93-113
Samodzielny Publiczny Centralny Szpital Kliniczny, Dept of Neurology
Warszawa, Poland, 02-097
Sponsors and Collaborators
Grifols Therapeutics LLC
  Study Documents (Full-Text)

Documents provided by Grifols Therapeutics LLC:
Study Protocol  [PDF] July 15, 2015
Statistical Analysis Plan  [PDF] August 4, 2017


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Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT02473952     History of Changes
Other Study ID Numbers: GTI1408
First Posted: June 17, 2015    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs