IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir
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|ClinicalTrials.gov Identifier: NCT03639207|
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : May 24, 2019
Hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma and end-stage liver disease. Ledipasvir/sofosbuvir is used to treat chronic HCV. The drug name for it is Harvoni. It is a very effective treatment, but it is expensive. Researchers have found a genetic variation that predicts how people will respond to this treatment. They want to learn more about this genetic link. It could help develop better treatments for HCV.
To study if certain inherited genetic differences and other factors affect the different ways patients respond to treatment with Harvoni.
Adults ages 18 who are members of the Kaiser Health Plan and have recently been treated for hepatitis C with Harvoni
Researchers will review medical records to identify a group of people who could be in the study.
Participants will provide a saliva sample at home. They will get instructions and kit to collect it in.
Participants will spit into a funnel until it reaches a mark on the funnel. It will be about 1 teaspoon of saliva with no bubbles.
They will return the sample in a prepaid mailer.
Researchers will do genetic tests on the samples. The participant data will be kept confidential. It will not be given to insurance companies.
Participants will not be given any test results.
|Condition or disease|
|Hepatitis C Virus|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir: Kaiser Permanente Northern California|
|Estimated Study Start Date :||May 29, 2019|
|Estimated Primary Completion Date :||September 30, 2026|
|Estimated Study Completion Date :||September 30, 2026|
Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California
- IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir [ Time Frame: 12 weeks post treatment ]virological relapse
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639207
|Contact: Thomas R O'Brien, M.D.||(301) firstname.lastname@example.org|
|United States, California|
|Kaiser Permanente Northern California||Not yet recruiting|
|Oakland, California, United States, 94612|
|Contact: David Witt, M.D. 415-444-2940 email@example.com|
|Principal Investigator:||Thomas R O'Brien, M.D.||National Cancer Institute (NCI)|