The purpose of this protocol is to identify and screen potential candidates for future
enrollment in a gene therapy clinical trial for HoFH.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
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Full eligibility criteria for NCT03018678
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Males and females ≥ 18 years of age
Clinical presentation consistent with homozygous FH
Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form
Known to carry confirmed mutations in genes affecting LDL receptor functionality other than the LDLR gene
History of cirrhosis based on documented histological evaluation or non-invasive imaging
Documented diagnosis of any of the following liver diseases: Hepatitis B or C; Biopsy-proven nonalcoholic steatohepatitis; Biopsy-proven alcoholic liver disease; Autoimmune hepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis; Wilson's disease; Hemochromatosis; alpha1 anti-trypsin deficiency
History of immunodeficiency diseases, including a positive HIV test result
Previous organ transplantation
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Inability to participate
All locations for NCT03018678
United States (1)
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
View full eligibility
Tris trial is registered with FDA with number: NCT03018678. The sponsor of the trial is University of Pennsylvania and it is looking for 21 volunteers for the current phase.
Official trial title: Screening Protocol for a Gene Therapy Trial in Subjects With Homozygous Familial Hypercholesterolemia
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