Status:
COMPLETED
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Refractory Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-30...
Detailed Description
ECU-MG-302 was an extension study designed to provide the participants who completed Study ECU-MG-301 an opportunity to receive eculizumab and collect clinical data to provide long-term safety and eff...
Eligibility Criteria
Inclusion
- Participant has completed Study ECU-MG-301.
- Participant has given written informed consent.
- Participant was willing and able to comply with the protocol requirements for the duration of the study.
- Female participant of childbearing potential must have had a negative pregnancy test (serum human chorionic gonadotropin). All participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.
Exclusion
- Participants who withdrew from Study ECU-MG-301 as a result of an adverse event related to study drug.
- Female participants who were pregnant, breastfeeding, or intended to conceive during the course of the study.
- Unresolved meningococcal infection
- Hypersensitivity to murine proteins or to one of the excipients of eculizumab
- Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.
Key Trial Info
Start Date :
November 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT02301624
Start Date
November 12 2014
End Date
January 15 2019
Last Update
February 5 2020
Active Locations (60)
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1
Birmingham, Alabama, United States, 35233
2
Los Angeles, California, United States, 90033
3
Orange, California, United States, 92868
4
Palo Alto, California, United States, 94304