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)
|ClinicalTrials.gov Identifier: NCT01667081|
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2012
Last Update Posted : November 30, 2017
This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis) multicenter study to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine whether 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. Participants from MK-5172-052 (NCT02092350) with CKD or cirrhosis will be followed for five years.
As of Amendment 03, the study design is revised such that continued enrollment will only be for participants who failed prior therapy with a grazoprevir regimen. Participants with CKD enrolled from MK-5172-052 (NCT02092350) will continue enrollment regardless of prior treatment-response and remain in this study for five years, while participants enrolled from all other studies with HCV RNA less than the lower limit of quantitation (LLOQ) will be discontinued and end their participation after the next scheduled visit. In addition, participants who receive other HCV treatments concurrent with this follow-up study or received other HCV treatments prior to this study will be discontinued and their data excluded from analysis.
|Condition or disease||Intervention/treatment|
|Hepatitis C||Drug: Grazoprevir|
|Study Type :||Observational|
|Estimated Enrollment :||3250 participants|
|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|
|Actual Study Start Date :||October 17, 2012|
|Estimated Primary Completion Date :||July 7, 2023|
|Estimated Study Completion Date :||July 7, 2023|
Participants who previously received grazoprevir as study treatment on a prior study.
Participants previously received study treatment with grazoprevir at the dose and frequency specified in the study protocol. Grazoprevir was not administered to participants in the course of this follow-up study.
- Time to Viral Relapse [ Time Frame: From last dose of grazoprevir up to ~60 months after enrollment in this study ]
- Number of Participants With Antiviral Resistance [ Time Frame: From last dose of grazoprevir up to ~60 months after enrollment in this study ]
- Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up [ Time Frame: From first visit in follow-up (Screening/Baseline) up to ~60 months after enrollment in this study ]
- Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up [ Time Frame: From first visit in follow-up (Screening/Baseline) up to ~60 months after enrollment in this study ]
Biospecimen Retention: Samples With DNA