Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 April 2019 |
Main ID: |
EUCTR2013-005099-17-HU |
Date of registration:
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26/05/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. 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 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.
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Scientific title:
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis |
Date of first enrolment:
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13/07/2015 |
Target sample size:
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60 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005099-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Estonia
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France
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Germany
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Hungary
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Lithuania
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Poland
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United States
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Contacts
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Name:
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Rhonda Griffin-Ass.Director,ClinDev
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Address:
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79 T.W. Alexander Drive, Research Triangle Park,
NC 27709
4101 Research Commons,
United States |
Telephone:
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+1 919 316 6693 |
Email:
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rhonda.griffin@grifols.com |
Affiliation:
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Grifols Therapeutics Inc. |
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Name:
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Rhonda Griffin-Ass.Director,ClinDev
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Address:
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79 T.W. Alexander Drive, Research Triangle Park,
NC 27709
4101 Research Commons,
United States |
Telephone:
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+1 919 316 6693 |
Email:
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rhonda.griffin@grifols.com |
Affiliation:
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Grifols Therapeutics Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female ages 18 to 85 years
2. Anti-AChR antibody positive
3. Confirmed diagnosis of generalized MG historically meeting the clinical criteria for diagnosis of MG defined by the MGFA classification of Class II, III, IV, or V historically (Appendix 2).
4. At Screening, subjects may have symptoms controlled by CS (for example, only ocular [Class I] symptoms may be evident or there may be no symptoms) or be MGFA Class II-IVa inclusive (Class IVb and Class V excluded). Note: Subjects who only have a history of ocular MG may not enroll.
5. On systemic CS for a minimum period of at least three months and on a stable CS dose of =15 mg/day and =60 mg/day (prednisone equivalent) for the month prior to Screening. Individuals on alternate day CS dosing will be judged to be on a daily dose equivalent to half their alternate day dose (i.e., 40 mg/every other day = 20 mg/day).
6. The investigator feels that tapering the CS dose is currently appropriate (to be commenced as prescribed during this protocol)
7. At least one previous completed attempt to taper CS in order to minimize CS dose
8. Subjects must be willing and able to provide written informed consent.
9. 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 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria: 1. Any dose change in concomitant immunosuppressant therapy, other than CS, in the prior six months
2. Any change in CS dose or acetylcholinesterase inhibitor (e.g., pyridostigmine) dose in the one month prior to Screening
3. A three-point change in QMG score, increased or decreased, between the Screening/Week -3 (Visit 0) and Baseline (Week 0 [Visit 1])
4. Any episode of MC in the one month prior to Screening
5. 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)
6. Thymectomy within the preceding six months prior to Screening
7. Rituximab, belimumab, eculizumab or any monoclonal antibody used for
immunomodulation within the past 12 months prior to Screening
8. History of non-response to IVIg when used in maintenance therapy of the subject’s MG, as judged by the investigator
9. Have received immune globulin treatment given by IV, subcutaneous, or intramuscular route within the last 3 months prior to Screening
10. Received plasma exchange (PLEX) performed within the last 3 months prior to Screening
11. Inadequate venous access
12. History of anaphylactic reactions or severe reactions to any blood-derived product
13. History of intolerance to any component of the IPs
14. Documented diagnosis of thrombotic complications to polyclonal IVIg therapy in the past
15. History of recent (within the last year) myocardial infarction or stroke
16. Uncontrolled congestive heart failure; embolism; or historically documented (within the last year) electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial fibrillation
17. Current known hyperviscosity or hypercoagulable state
18. Currently receiving anti-coagulation therapy (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], parenteral anticoagulants [e.g., fondaparinux]). Note that oral anti-platelet agents are allowed (e.g., aspirin, clopidogrel, ticlodipine)
19. History of chronic alcoholism or illicit drug abuse (addiction) in the 12 months preceding the Screening/Week -3 (Visit 0)
20. Active psychiatric illness that interferes with compliance or communication with health care personnel
21. Females of child-bearing potential who are pregnant, have a positive serum pregnancy test (human chorionic gonadotropin [HCG]-based assay), breastfeeding, or 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 t
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Myasthenia Gravis
MedDRA version: 18.1
Level: PT
Classification code 10028417
Term: Myasthenia gravis
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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Trade Name: GAMUNEX 10% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0.10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): The primary efficacy endpoint will be the percent of subjects in each arm achieving a 50% or greater reduction in CS dose (prednisone or equivalent) at Week 39 (Visit 14) from Baseline/Week 0 (Visit 1).
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Main Objective: The primary objective of this study is to evaluate the efficacy of IV infusions of IGIV-C as compared to Placebo in reducing the maintenance dosage of corticosteroids in corticosteroid (CS)-dependent subjects with MG when given as an initial loading dose (2 g/kg) followed by 12 maintenance doses (1 g/kg) every 3 weeks through Week 36 by assessing the percent of subjects achieving a 50% or greater reduction in CS dose(prednisone or equivalent) at Week 39 (Visit 14) from Baseline/Week 0 (Visit 1).
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Secondary Objective: The secondary objectives of this study are to evaluate the efficacy of IGIV-C as compared to Placebo from baseline through Week 39 in the following: * Percent reduction in daily CS (prednisone or equivalent) dose from Baseline to Week 39 (Visit 14) * Time to first episode of MG worsening, as defined in Section 3.3.3 “Definition and Management of MG Worsening”, from Baseline/Week 0 through Week 39 (Visit 1 through Visit 14)
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Timepoint(s) of evaluation of this end point: at Week 39 (Visit 14) from Baseline/Week 0 (Visit 1).
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. Throughout the study at each visit until the Week 39 including.
2. Throughout the study at each visit until the Week 39 including.
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Secondary end point(s): 1. Percent reduction in daily CS (prednisone or equivalent) dose from Baseline/Week 0 to Week 39 (Visit 14)
2. Time to first episode of MG worsening, as defined in Section 3.3.3 “Definition and Management of MG Worsening”, from Week 0 through Week 39 (Visit 1 through Visit 14)
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Secondary ID(s)
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GTI1306
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2013-005099-17-LT
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Source(s) of Monetary Support
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Grifols Therapeutics Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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