IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir

NCT03639207 | Withdrawn

• 2 other identifiers: 99991813418-C-N134
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: 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. Objective: To study if certain inherited genetic differences and other factors affect the different ways patients respond to treatment with Harvoni. Eligibility: Adults ages 18 who are members of the Kaiser Health Plan and have recently been treated for hepatitis C with Harvoni Design: 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. ...

Conditions

Hepatitis C Virus

Keywords

IFNL4; Genetics; Ledipasvir/Sofosbuvir Treatment

Outcome Measures

Primary Outcomes (1)

• IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir

  virological relapse

  12 weeks post treatment

Study Arms (1)

1

Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California

You may qualify if:

• At least 18 years of age
• Chronic HCV VGT-1 infection
• Completed treatment with ledipasvir/sofosbuvir (with or without ribavirin) for either 8, 12 or 24 weeks at a participating KP-NC clinical site
• Data available to determine virological relapse and SVR12

You may not qualify if:

• Otherwise eligible subjects who have left KPNC will not be included in the study
• Otherwise eligible subjects who cannot provide informed consent in English will not be included in the study

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Thomas R O'Brien, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 21, 2018
• Study Start: June 15, 2018
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07