A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).
- Conditions
- Myasthenia GravisMedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003997-18-CZ
- Lead Sponsor
- Grifols Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
1. Male or female, ages 18 to 85 years
2. Anti-AChR antibody positive
3. Confirmed diagnosis of generalized MG. Historically, subjects may have previously had the Myasthenia Gravis Foundation of America (MGFA) Class II, III, IV, or V.
4. MGFA classification of Class II, III, or IVa inclusive at Screening.
5. QMG score =10 at Screening. Note: Subjects who only have a history of ocular MG may not enroll.
6. 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):
-Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to Screening and no immunosuppressants
- Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks priorto Screening and/or only one of the following:
* Prednisone (up to 60 mg/day or equivalent) for at least one month prior to Screening, or
* Azathioprine for at least 6 months prior to Screening, or
* Mycophenolate mofetil for at least 6 months prior to Screening, or
* Cyclosporine or tacrolimus for at least 3 months prior to Screening
- 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:
* Azathioprine for at least 6 months prior to Screening, or
* Mycophenolate mofetil for at least 6 months prior to Screening, or
* Cyclosporine or tacrolimus for at least 3 months prior to Screening
7. 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).
8. Subjects must be willing to comply with all aspects of the clinical trial protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Have received cyclophosphamide or any other immunosuppressive agent apart from the ones allowed per inclusion criteria within the past 6 months
2. Any change in MG treatment regimen between Screening (Week -3, Visit 0) and Baseline (Week 0, Visit 1)
3. Greater than two (>2) point change in QMG score, increased or decreased, between Screening (Week -3, Visit 0) and Baseline (Week 0, Visit 1)
4. Any episode of myasthenic crisis in the one month prior to Screening
5. Evidence of malignancy or bulky thymoma potentially requiring surgical intervention during the course of the trial
6. Thymectomy within the preceding three months
7. Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation within the past 12 months
8. Have received immune globulin (Ig) treatment given by IV, subcutaneous, or intramuscular route within the last 3 months
9. Current known hyperviscosity or hypercoagulable state
10. 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)
11. Plasma exchange (PLEX) performed within the last 2 months
12. History of non-response to IVIg when used in maintenance therapy of the subject’s MG, as judged by the Investigator
13. Any comorbid condition that in the opinion of the Investigator would put the subject at undue safety risk or compromise the ability of the subject to participate in the trial or the scientific integrity of the study
14. Inadequate venous access to support repeated intravenous infusions
15. History of anaphylactic reactions or severe reactions to any blood-derived product
16. History of intolerance to any component of the IP
17. Documented diagnosis of thrombotic complications to polyclonal IVIg therapy in the past
18. History of recent (within the last year) myocardial infarction or stroke
19. Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation
20. History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Screening/Week -3 (Visit 0)
21. Active psychiatric illness that interferes with compliance or communication with health care personnel
22. Females of child-bearing potential who are pregnant or have a positive serum pregnancy test (beta-human chorionic gonadotropin [ß-HCG]-based assay)
23. Females who are breastfeeding
24. Females of child-bearing potential who are unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence*) throughout the study.
* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.)
25. Currently receiving, or having received within 1 month prior to the Screening/Week -3 (Visit 0), any investigational medicinal product or device.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method