A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis exacerbations. All patients will receive a single dose course of IGIV-C treatment followed by 28-days of post-infusion assessments.
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersMyasthenia Gravis ExacerbationsTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-005098-28-CZ
- Lead Sponsor
- Grifols Therapeutics LLC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
A subject must meet all the following inclusion criteria to be eligible for participation in this
study:
1. Male or female aged =18 years.
2. 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).
3. Subjects who meet the clinical criteria for diagnosis of MG with an exacerbation defined as worsening of MG symptoms as defined by an MGFA classification IVb or V.
4. Subjects on long-term (8 weeks) corticosteroid treatment for MG.
5. Female subjects of child-bearing potential must have a negative test for pregnancy (human chorionic gonadotropin (HCG)-based assay).
6. 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.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study:
1. Subjects who have received immune globulin treatment given by IV, subcutaneous or intramuscular route within the last 30 days.
2. Subjects with documentation of a lack of clinical response to IVIG therapy for MG.
3. Subjects documented positive for antibodies directed against MuSK.
4. Subjects with CS treatment initiated within the last 8 weeks or modified within the last 2 weeks.
5. Subjects with PLEX within the last 30 days.
6. Subjects with MG exacerbation attributable to change in medication 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 >12×109/L and differential white blood cell count of
>10% band neutrophils (>1.2×109/L), and 4) pulmonary infiltrate with
consolidation on chest Xray. Alternatively, other signs and symptoms
may be considered for the diagnosis of evident infection
according to the Investigator's judgement.
7. Subjects with inadequate venous access.
8. Subjects with a history of anaphylactic reactions or severe reactions to any blood-derived product.
9. Subjects with a history of intolerance to any component of the investigational products (IPs).
10. Subjects with a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.
11. Subjects with a history of recent (within the last year) myocardial infarction, stroke or uncontrolled hypertension.
12. Subjects who suffer from uncontrolled congestive heart failure, embolism or documented electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation.
13. Subjects with current known hyperviscosity or hypercoagulable state.
14. Subjects currently receiving anti-coagulation therapy.
15. Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Baseline Visit.
16. Subjects with active psychiatric illness that interferes with compliance or communication with health care personnel.
17. Females who are pregnant, breastfeeding, or of child-bearing potential and 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.)
18. Subjects with any medical condition which makes the clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the Investigator’s judgment.
19. Subjects currently receiving, or having received within 3 months prior to the Baseline Visit, any investigational medicinal product or device.
20. Subjects who are unlikely to adhere to the protocol requirements or are likely to be uncooperative or unable to provide a storage serum/plasma sample prior to the first
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