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Efgartigimod IV for Myasthenia Gravis
Study Summary
This trial is investigating the effects of a drug called efgartigimod in children and adolescents aged 2-18 with a condition called gMG. The trial will last up to 28 weeks for each participant, and will involve two parts: a dose-confirmatory part (8 weeks) and a treatment response-confirmatory part (18 weeks).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I agree not to donate sperm during the trial.I have been diagnosed with Generalized Myasthenia Gravis.Female participants must have a negative pregnancy test.I have had a major surgery or serious disease recently.I have had, or will have, a thymectomy within 3 months of joining the trial.You are allergic to efgartigimod or any of its ingredients.You have had problems with alcohol, drugs, or medication within the past year.You have a current active viral infection shown in a blood test.I have used specific medications or treatments recently.Your immunoglobulin (IgG) levels are too low.I am between 2 and 17 years old.You have been diagnosed with Myasthenia Gravis and fall into MGFA classes II, III, or IVa.My condition did not improve with immunosuppressants, steroids, or AChE inhibitors.I did not improve after receiving plasma exchange treatment.You have a positive test for anti-AChR antibodies.My muscle weakness is getting worse because of an infection or medication.I am not pregnant, breastfeeding, or planning to become pregnant.My myasthenia gravis is classified as MGFA class I, IVb, or V.I have an autoimmune disease that could affect myasthenia gravis evaluation.I had cancer before but was treated successfully.I have not received a live vaccine in the last 4 weeks.I do not have any serious ongoing infections.
- Group 1: Efgartigimod
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this study only include seniors, or can people of all ages participate?
"The target age range for participants in this trial are children that are at least 2 years old, but not yet adults at 18 years old."
Are there still places available in this research program for new participants?
"That is correct. According to the listing on clinicaltrials.gov, this trial is still looking for participants. The study was first posted on October 26th, 2021 and was most recently updated on November 2nd, 2020. At the moment, the study is only admitting 12 patients from 2 different sites."
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