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Gene Therapy

RGX-501 for Hypercholesterolemia

N/A
Waitlist Available
Research Sponsored by Regenxbio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
To be eligible to participate in this study, a participant must have previously received RGX-501 in a separate parent trial, and the participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent after the nature of the study has been explained, prior to any research-related procedures.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after receiving treatment with rgx-501
Awards & highlights

Study Summary

This long-term observational study is designed to follow subjects who, during another Clinical Study, received gene therapy treatment used to treat their Homozygous Familial Hypercholesterolemia (HoFH) disease. This study is intended to follow those subjects for up to 5 years since they received treatment to look for any long-term safety concerns. There is no investigational drug or therapy provided as part of this study.

Eligible Conditions
  • Hypercholesterolemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years after receiving treatment with rgx-501
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after receiving treatment with rgx-501 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of incidents of new and unexpected adverse events and serious adverse events.
Secondary outcome measures
Cocaine
The absolute LDL-C level in mg/dL by beta quantification
Therapeutic procedure

Trial Design

1Treatment groups
Experimental Treatment
Group I: RGX-501Experimental Treatment1 Intervention
Study participants who have received RGX-501 gene therapy in a separate parent trial

Find a Location

Who is running the clinical trial?

Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
2,285 Total Patients Enrolled
2 Trials studying Hypercholesterolemia
13 Patients Enrolled for Hypercholesterolemia
REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
2,285 Total Patients Enrolled
2 Trials studying Hypercholesterolemia
13 Patients Enrolled for Hypercholesterolemia
REGENXBIO Inc.Lead Sponsor
23 Previous Clinical Trials
2,527 Total Patients Enrolled
2 Trials studying Hypercholesterolemia
13 Patients Enrolled for Hypercholesterolemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501
2019. "A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04080050.
~1 spots leftby Sep 2024
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