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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)

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ClinicalTrials.gov Identifier: NCT01667081
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2012
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C Drug: Grazoprevir

Detailed Description:

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.

As of Amendment 04, the protocol has been updated to include enrollment of pediatric participants from protocol MK-5172-079 (NCT03379506). Enrollment is limited to participants who experienced virologic failure associated with 1 or more treatment-emergent resistant associated substitutions (RASs) present at 12 weeks after receiving grazoprevir treatment in prior treatment study MK-5172-079 (NCT03379506).


Study Type : Observational
Estimated Enrollment : 3250 participants
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
Actual Study Start Date : October 17, 2012
Estimated Primary Completion Date : July 7, 2023
Estimated Study Completion Date : July 7, 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Grazoprevir
Participants who previously received grazoprevir as study treatment on a prior study.
Drug: Grazoprevir
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.



Primary Outcome Measures :
  1. Time to Viral Relapse [ Time Frame: From last dose of grazoprevir up to ~60 months after enrollment in this study ]
  2. Number of Participants With Antiviral Resistance [ Time Frame: From last dose of grazoprevir up to ~60 months after enrollment in this study ]
  3. 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 ]
  4. 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
Blood samples will be collected and retained for purposes of DNA testing and plasma will be retained for future biomedical research.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult and pediatric participants previously treated with a grazoprevir-containing regimen while enrolled in a Merck study. All participants enrolled having failed therapy from prior studies (except MK-5172-052 [NCT02092350]) will be followed for 3 years in the current follow-up study, and all participants enrolled from MK-5172-052 (irrespective of prior response) will be followed for 5 years in the current follow-up study.
Criteria

Inclusion Criteria:

  • Previously participated in a HCV treatment protocol that included grazoprevir in the treatment regimen
  • Must enroll in the present study within three months of the last study visit of their previous protocol in which they received a grazoprevir-containing regimen
  • For Amendment 03: Adult participants must have received a grazoprevir-containing regimen in a prior trial and have been identified as having failed therapy in that study
  • For Amendment 04: Pediatric participants must have received at least 1 dose of a grazoprevir-containing regimen and experienced virologic failure with 1 or more associated treatment-emergent RASs at Follow-up Week 12 in MK-5172-079 (NCT03379506)

Exclusion Criteria:

  • Has received HCV therapy after completion of the protocol-defined grazoprevir treatment trial regimen and before or after entry into this follow-up study
  • For Amendment 03: Has failed therapy due to re-infection, defined as an HCV RNA sample with a different genotype than the baseline genotype in the prior treatment study, or an HCV RNA sample determined to be reinfection by phylogenetic analysis with comparison to the baseline sequence in the prior treatment study
  • For Amendment 03: Has failed therapy and received retreatment with HCV therapy, except in the case where they were re-treated in a Merck-sponsored protocol

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01667081     History of Changes
Other Study ID Numbers: 5172-017
2012-002232-85 ( EudraCT Number )
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections