Hepatitis C VirusNCT03639207
IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir
An observational study of Hepatitis C Virus, run by National Cancer Institute (NCI).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatitis C Virus
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2018to 3 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir: Kaiser Permanente Northern California
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.
Read more
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.
...
Read the 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.
- Conditions
- Hepatitis C Virus
- Keywords
- IFNL4, Genetics, Ledipasvir/Sofosbuvir Treatment
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California |
What is being measured
The primary outcome is the main question the study is designed to answer.
IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir
virological relapse
Measured: 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Jun 2018 (estimated)
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Why it stopped: Subject Research)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas R O'Brien, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639207
- Sponsor's protocol ID
- 999918134
- Other IDs
- 18-C-N134
- Status last verified
- Jul 2019
- First submitted
- 18 Aug 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir: Kaiser Permanente Northern California
- ClinicalTrials.gov ID
- NCT03639207
- Acronym / sponsor ID
- 999918134
- Conditions
- Hepatitis C Virus
- Keywords
- IFNL4, Genetics, Ledipasvir/Sofosbuvir Treatment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Subject Research)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with ledipasvir/sofosbuvir in the Kaiser Permanente Northern California
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir
Time frame: 12 weeks post treatment
virological relapse
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R O'Brien, M.D. principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus, run by National Cancer Institute (NCI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IFNL4-deltaG/TT polymorphism and treatment response to ledipasvir/sofosbuvir (time frame: 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.