A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B

ClinicalTrials.gov ID: NCT06379789

Public ClinicalTrials.gov record NCT06379789. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 21, 2026, 12:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Two-Part Open-Label Study of REGV131-LNP1265, A CRISPR/Cas9 Based Coagulation Factor IX Gene Insertion Therapy in Participants With Hemophilia B

Study identification

NCT ID: NCT06379789
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Regeneron Pharmaceuticals; Industry
Enrollment: 130 participants

Conditions and interventions

Conditions

Hemophilia B

Interventions

LNP1265 Drug
REGV131 Drug

Drug

Eligibility (public fields only)

Age range: 2 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 10, 2024
Primary completion: Aug 13, 2034
Completion: Aug 13, 2047
Last update posted: May 18, 2026

2024 – 2047

United States locations

U.S. sites: 14
U.S. states: 10
U.S. cities: 12

Facility	City	State	ZIP	Site status
Orthopaedic Hemophilia Treatment Center	Los Angeles	California	90007	Recruiting
David Geffen School of Medicine at UCLA	Los Angeles	California	90024	Recruiting
Children's Hospital Los Angeles	Los Angeles	California	90027	Recruiting
University of California Davis	Sacramento	California	95817	Recruiting
University California San Francisco	San Francisco	California	94143	Recruiting
University of Colorado Hemophilia and Thrombosis Center	Aurora	Colorado	80045	Recruiting
Yale HTC	New Haven	Connecticut	06510	Recruiting
University of Florida	Gainesville	Florida	32610	Recruiting
Indiana Hemophilia and Thrombosis Center	Indianapolis	Indiana	46260	Recruiting
Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders	New Orleans	Louisiana	70112	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	43205	Recruiting
Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania	19104	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06379789, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 18, 2026 · Synced May 21, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06379789 live on ClinicalTrials.gov.

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