Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
REGENXBIO Inc.
This is a prospective follow-up study to evaluate the long-term safety and efficacy after a single administration of RGX-121. Eligible participants are those who previously have enrolled in clinical study RGX-121-101 or RGX-121-1102 and received a single intracisternal (IC) or intracerebroventricular (ICV) infusion of RGX-121. Enrollment of each participant will occur the same day or after the participant has completed the end of study (EOS) visit or early termination visit (ET) from the previous (parent) study. Participants will be followed in this study cumulatively for up to 5 years after RGX-121 administration (inclusive of the parent study). No treatment will be administered under this observational protocol. The total study duration for each participant may vary depending on when they enroll in the current study following RGX-121 administration in the parent study.
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
To be eligible, a participant must have previously received RGX-121 in a separate parent trial.
Participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent
You may not be if
Participant has not received RGX-121 previously in a separate parent trial.
