Aurora, CONCT06379789Now EnrollingIRB Ready

Hemophilia B Clinical Trial in Aurora, CO

Access cutting-edge hemophilia b treatment through this phase 1/2 clinical trial at a research site in Aurora. Study-provided care at no cost to qualified participants.

Sponsored by Regeneron Pharmaceuticals

Quick Self-Assessment

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Expert Care in Aurora

Access hemophilia b specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hemophilia b treatment provided free

Apply for This Aurora Location

Check if you qualify for this hemophilia b clinical trial in Aurora, CO

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Aurora

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Aurora site if eligible
  4. 4Begin participation

About This Hemophilia B Study in Aurora

Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy. The main aim of this study is to find

Sponsor: Regeneron Pharmaceuticals

Who Can Participate

Inclusion Criteria

Confirmed diagnosis of severe or moderately severe hemophilia B with medical history of FIX functional activity (≤2% or \<0.02 IU/mL) or documented genotype known to produce severe hemophilia B
Currently taking FIX prophylaxis and previous experience with FIX therapy, as defined in the protocol
Participation in the lead-in period of this interventional study OR a separate lead-in study (R0000-HEMB-2187 \[NCT05568459\]) for at least 6 months for ABR data while taking FIX prophylaxis, as defined in the protocol Key

Exclusion Criteria

History of FIX inhibitor (clinical or laboratory-based assessment) on 2 or more occasions
Bethesda inhibitor titer greater than the Upper Limit of Normal (ULN) at screening
Detectable pre-existing antibodies to the AAV8 capsid; as measured by Enzyme-Linked ImmunoSorbent Assay (ELISA) at prescreening (or final lead-in visit, if applicable)
Any significant underlying liver disease such as: cholestatic liver disease, liver cirrhosis, portal hypertension, splenomegaly, hepatic encephalopathy
Evidence of advanced liver fibrosis or significant fatty liver, as defined in the protocol
Evidence of cirrhosis and/or portal hypertension as assessed by abdominal ultrasound at screening or measured within 6 months prior to the screening visit
History of arterial or venous thrombo-embolic events, as defined in the protocol
History of hypersensitivity to corticosteroids or known medical condition that requires chronic administration of corticosteroids
Previously received any AAV gene-based therapy or intends to receive approved or investigational AAV-based gene therapy other than REGV131-LNP1265 during the study period NOTE: Other Inclusion/Exclusion Protocol Defined Criteria Apply

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06379789) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hemophilia B Treatment Options in Aurora, CO

If you're searching for hemophilia b treatment options in Aurora, CO, this clinical trial (NCT06379789) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced hemophilia b specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hemophilia b clinical trials near you to find additional studies recruiting in your area.

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