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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 : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date August 18, 2018
First Posted Date August 21, 2018
Last Update Posted Date April 19, 2019
Estimated Study Start Date April 24, 2019
Estimated Primary Completion Date September 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 18, 2018)
IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir [ Time Frame: 12 weeks post treatment ]
virological relapse
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03639207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir
Official Title IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir: Kaiser Permanente Northern California
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.

Detailed Description Hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma (HCC) and end stage liver disease - successful treatment markedly reduces those risks. Ledipasvir/sofosbuvir is a highly effective, but expensive, treatment for chronic hepatitis C. Previously, we demonstrated that genetic variation in IFNL4 predicts response to this regimen. We now propose to examine the association between genotype for the functional IFNL4-DeltaG/TT polymorphism and treatment response among patients enrolled in a large managed care organization. In a two-stage design, limited demographic and clinical data for patients who have been treated with ledipasvir/sofosbuvir will be ascertained from an electronic database. In the second stage, additional demographic and clinical data will be extracted from medical records and consented patients will provide a specimen for IFNL4 genotyping. These data will be combined to examine associations of IFNL4-DeltaG/TT genotype and other variables with response to ledipasvir/sofosbuvir. We will also develop a clinical prediction model for response to ledipasvir/sofosbuvir treatment. These results could inform more efficient treatment of HCV in the United States and globally.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California
Condition Hepatitis C Virus
Intervention Not Provided
Study Groups/Cohorts 1
Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 18, 2018)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2026
Estimated Primary Completion Date September 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

Subject Inclusion Criteria:

  • 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

EXCLUSION CRITERIA:

Subject Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Thomas R O'Brien, M.D. (301) 435-4728 obrient@epndce.nci.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03639207
Other Study ID Numbers 999918134
18-C-N134
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Thomas R O'Brien, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date August 15, 2018