Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
This three-year study (participants with chronic kidney disease [CKD] or cirrhosis will be followed for five years) multicenter study is being done to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine if they remain hepatitis C virus (HCV)-RNA negative over time, and to determine if they have developed antiviral resistance. The study will also evaluate long-term adverse events in this population.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Long-Term Follow-Up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated With MK-5172 in a Prior Clinical Trial|
- Time to Viral Relapse [ Time Frame: From Last Dose of Grazoprevir Up to ~60 Months After Enrollment in This Study ] [ Designated as safety issue: No ]
- Number of Participants With Antiviral Resistance [ Time Frame: From Last Dose of Grazoprevir Up to ~60 Months After Enrollment in This Study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples will be collected and retained for purposes of DNA testing and plasma will be retained for future biomedical research.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2020|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
Participants previously received grazoprevir as study treatment.
Grazoprevir was not administered to participants in the course of this study.
Other Name: Participants previously received study treatment with grazoprevir at the dose and frequency specified in the study protocol.
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