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COMPLETED

AAV Gene Therapy Screening/Observational Protocol (ECLIPSE)

NCT04272554 · View on ClinicalTrials.gov ↗

Study Summary

Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.

Study Locations (20)

Other

  • Royal Children's Hospital, Parkville — Melbourne
  • The Alfred Hospital — Melbourne
  • Calvary Mater Hospital — Newcastle

California

  • Children's Hospital of Los Angeles — Los Angeles
  • University of California - Davis — Sacramento

North Carolina

  • University of North Carolina (UNC) — Chapel Hill
  • East Carolina University — Greenville

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland
  • Nationwide Childrens Hospital — Columbus

Tennessee

  • St. Jude Children's Research Hospital — Memphis
  • Vanderbilt University Medical Center — Nashville

Arizona

  • Phoenix Childrens Hospital — Phoenix

Florida

  • University of South Florida — Tampa

Illinois

  • Rush University Medical Center — Chicago

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2020-02-14
Est. Completion 2022-10-10

Sponsor

Spur Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04272554

The ClinicalTrials.gov registry entry for NCT04272554 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 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spur Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Hemophilia B appearing as the primary indexed condition, and to 0 interventions. 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: NCT04272554 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, California, North Carolina. 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 NCT04272554 about?

NCT04272554 is a clinical study titled "AAV Gene Therapy Screening/Observational Protocol (ECLIPSE)". Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients...

What is the current status of trial NCT04272554?

This trial is currently completed. The enrollment target is 37 participants. The study started on 2020-02-14. Estimated completion is 2022-10-10.

What conditions does trial NCT04272554 study?

This clinical trial studies the following conditions: Hemophilia B, Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Haematologic Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT04272554?

This trial is sponsored by Spur Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04272554 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. 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