Screening Genotyping Assay for a NASH Clinical Trial (Version C)
Research type
Research Study
Full title
Protocol for the use of a genotyping clinical trial assay in a pharmaceutical company-sponsored clinical trial series investigating a medicinal product for the treatment of non-alcoholic steatohepatitis (NASH).
IRAS ID
309366
Contact name
Arielle Tawfik
Contact email
Sponsor organisation
Almac Diagnostic Services
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
D7830C00004, Therapeutic Sponsor Clinical Study Protocol; 2022-001629-65, EudraCT number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In this study whole blood and buccal samples will be tested by Almac using an investigational in vitro diagnostic device. This testing is part of the screening process to determine if someone is suitable for a pharmaceutical-company sponsored study which is investigating the pharmaceutical company's drug for the treatment of a liver disease called non-alcoholic steatohepatitis (NASH). The PNPLA3 gene can contain a certain common variation, meaning that it may not work correctly, and this can affect the amount of fat build up in the liver and increase the risk of NASH. The purpose of the CTA is to determine if a potential study participant has two copies of the PNPLA3 variation, one copy of the PNPLA3 variation or no copies. Those with one or two copies may be eligible for the study and will continue with the remaining pharmaceutical-company screening.
In addition to determining if someone may be eligible to participate in the pharmaceutical company-sponsored study, the results of the analysis of blood and buccal samples, using the investigational device, will be used to establish the clinical effectiveness of the assay as a diagnostic test used to help match a NASH patient to the pharmaceutical company’s drug (e.g., a companion diagnostic).
Whole blood and buccal samples collected from the study subjects will be sent to Almac for testing using the investigational device by the study sponsor. Patient/subject recruitment, informed consent and sample collection is outside the scope of this study and falls under the remit of the pharmaceutical study.REC name
HSC REC B
REC reference
23/NI/0070
Date of REC Opinion
19 Jun 2023
REC opinion
Favourable Opinion