RGX-111 for Hurler Syndrome

Sheba Medical Center, Tel HaShomer, Israel
Hurler Syndrome+2 More ConditionsRGX-111 - Genetic
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a gene therapy is safe and tolerated by patients with MPS I, a disease that affects the nervous system.

Eligible Conditions
  • Hurler Syndrome
  • Mucopolysaccharidosis Type I (MPS I)
  • Hurler-Scheie Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104

104 Weeks
Safety: Number of participants with treatment-related adverse events
24 Weeks
Safety: Number of participants with treatment-related adverse events and serious adverse events
Week 24
Vector shedding
Week 104
Change in adaptive behavior
Week 104
Change in neurodevelopmental parameters

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Dose 1; 1x10^10 GC/g brain mass of RGX-111
1 of 2
Dose 2; 5x10^10 GC/g brain mass of RGX-111
1 of 2

Experimental Treatment

8 Total Participants · 2 Treatment Groups

Primary Treatment: RGX-111 · No Placebo Group · Phase 1 & 2

Dose 1; 1x10^10 GC/g brain mass of RGX-111
Genetic
Experimental Group · 1 Intervention: RGX-111 · Intervention Types: Genetic
Dose 2; 5x10^10 GC/g brain mass of RGX-111
Genetic
Experimental Group · 1 Intervention: RGX-111 · Intervention Types: Genetic

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12, week 24, week 36, week 52, week 78, week 104

Who is running the clinical trial?

REGENXBIO Inc.Lead Sponsor
22 Previous Clinical Trials
2,519 Total Patients Enrolled
REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
2,285 Total Patients Enrolled
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
2,285 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Are there vacancies available for participants in this experiment?

"This clinical trial is currently in progress, having been initially posted on April 3rd 2019 and modified most recently on December 13th 2021. The details of the study can be found on clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

What is the uppermost participant limit for this clinical experiment?

"Affirmative. On clinicaltrials.gov, there is evidence that this medical trial commenced on April 3rd 2019 and has been updated recently on December 13th 2021. The researchers are searching for 11 participants from 2 distinct locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.