RecruitingNot ApplicableNCT04817462

Liver Biopsy In Haemophilia Gene Therapy


Sponsor

University College, London

Enrollment

10 participants

Start Date

Aug 5, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To perform a liver biopsy in haemophilia A and B patients with endogenous FVIII:C/FIX:C expression at \>1% any time after gene transfer following AAV mediated gene transfer. This is to obtain tissue for analysis, to understand if FIX/FVIII transgenic protein expression is mediated by AAV proviral DNA that is integrated into the host cell DNA or if stable expression in humans is mediated by episomal maintained AAV genome.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Liver biopsy for people with hemophilia a, severe and hemophilia b, severe. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELiver biopsy

The study population is patients with either haemophilia A or B who have previously been administered gene therapy treatment in one of three specific gene therapy clinical trials. In this study they will have a liver biopsy performed to take up to 3 samples for laboratory analysis.


Locations(1)

Royal Free Hospital

London, United Kingdom

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NCT04817462


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