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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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01667081
First received: August 14, 2012
Last updated: August 16, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Grazoprevir
Phase 3

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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.

Estimated Enrollment: 3250
Study Start Date: October 2012
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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: Participants must have received a grazoprevir-containing regimen in a prior trial and have been identified as having failed therapy in that study.

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01667081     History of Changes
Other Study ID Numbers: 5172-017  2012-002232-85 
Study First Received: August 14, 2012
Last Updated: August 16, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016