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COMPLETED

Long-term Follow-up Gene Therapy Study for RPGR- XLRP

NCT04312672 · View on ClinicalTrials.gov ↗

Study Summary

This is a long-term follow-up study assessing safety of patients for up to 60 months following advanced therapy investigational medicinal product (ATIMP) AAV5-hRKp.RPGR vector in participants with XLRP caused by mutations in RPGR.

Interventions

  • BIOLOGICAL AAV5-hRKp.RPGR

Study Locations (5)

Other

  • Leeds Teaching Hospitals NHS Trust — Leeds
  • Moorfields Eye Hospital — London

Massachusetts

  • Massachusetts Eye and Ear Infirmary — Boston

Michigan

  • Univ of Michigan Medical Center — Ann Arbor

Pennsylvania

  • University of Pittsburgh Medical Center — Pittsburgh

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2017-07-31
Est. Completion 2025-09-17

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04312672

The ClinicalTrials.gov registry entry for NCT04312672 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention — of which AAV5-hRKp.RPGR is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04312672 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Other, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04312672 about?

NCT04312672 is a clinical study titled "Long-term Follow-up Gene Therapy Study for RPGR- XLRP". This is a long-term follow-up study assessing safety of patients for up to 60 months following advanced therapy investigational medicinal product (ATIMP) AAV5-hRKp.RPGR vector in participants with XLRP caused by mutations in RPGR.

What is the current status of trial NCT04312672?

This trial is currently completed. The enrollment target is 42 participants. The study started on 2017-07-31. Estimated completion is 2025-09-17.

What conditions does trial NCT04312672 study?

This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04312672?

The interventions under investigation include: AAV5-hRKp.RPGR (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04312672?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04312672 being conducted?

This trial has 5 study locations across Massachusetts, Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial