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NCT04794101 · ClinicalTrials.gov registry record · Phase 3

Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

A Phase 3 study of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.

Active
Registry status
Phase 3
Development phase
97
Enrollment target
20
Study locations

NCT04794101 is a Phase 3 study of X-Linked Retinitis Pigmentosa that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 97 participants, above the 46-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (111% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT04794101, a Phase 3 study of X-Linked Retinitis Pigmentosa, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
97 participants
Enrollment target
20
Study locations

Study Summary

A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)

Conditions Studied

X-Linked Retinitis Pigmentosa

Interventions

  • BIOLOGICAL Genetic: AAV5-hRKp.RPGR Intermediate Dose
  • BIOLOGICAL Genetic: AAV5-hRKp.RPGR Low Dose

Study Locations (20)

Other

  • Ghent University Hospital - Ghent
  • Rigshospitalet Glostrup - Glostrup Municipality
  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts - Paris
  • Hadassah Medical Center - Jerusalem
  • Azienda Ospedaliero Universitaria Careggi - Florence
  • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli - Naples
  • VUMC Amsterdam - Amsterdam
  • Radboudumc - Nijmegen
  • Hosp Univ Fund Jimenez Diaz - Madrid
  • University Hospital Basel, Eye Clinic/Institute of Molecular and Clinical - Basel

California

  • Shiley Eye Institute Jacobs Retina Center - La Jolla
  • Childrens Hospital Los Angeles - Los Angeles
  • Stanford Health Care - Palo Alto

Florida

  • VitreoRetinal Associates, PA - Gainesville

Georgia

  • Emory University - Atlanta

Massachusetts

  • Massachusetts Eye and Ear Infirmary - Boston

Michigan

  • Univ of Michigan Medical Center - Ann Arbor

North Carolina

  • Duke Eye Center - Durham

Pennsylvania

  • University of Pittsburgh Medical Center (UPMC) - Pittsburgh

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2020-12-04
Est. Completion 2029-12-07
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04794101

The ClinicalTrials.gov registry entry for NCT04794101 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (111% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 2 interventions - of which Genetic: AAV5-hRKp.RPGR Intermediate Dose is the first listed.

NCT04794101 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04794101 about?

NCT04794101 is a clinical study titled "Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene". A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)

What is the current status of trial NCT04794101?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2020-12-04. Estimated completion is 2029-12-07.

What conditions does trial NCT04794101 study?

This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa.

What interventions are being tested in trial NCT04794101?

The interventions under investigation include: Genetic: AAV5-hRKp.RPGR Intermediate Dose (BIOLOGICAL), Genetic: AAV5-hRKp.RPGR Low Dose (BIOLOGICAL).

Who is sponsoring clinical trial NCT04794101?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04794101 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.