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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: November 9, 2014
Last verified: November 2014
  Purpose

This three-year 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.


Condition Intervention
Hepatitis C
Drug: Grazoprevir

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 ~ 36 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 ~ 36 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.


Estimated Enrollment: 3250
Study Start Date: October 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Grazoprevir
Participants previously received grazoprevir as study treatment.
Drug: Grazoprevir
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants who received at least one dose of grazoprevir while enrolled in a study and that achieved undetectable HCV-RNA status and did not start any new HCV-RNA therapy between the end of the previous study and enrollment in this study.

Criteria

Inclusion Criteria:

  • Previously participated in an grazoprevir protocol and received at least one dose of grazoprevir
  • Must enroll in the present study within one year of the treatment portion of the previous grazoprevir protocol except in the circumstance where the previous protocol has a follow-up period ≥1 year

Exclusion Criteria:

  • None
  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

No publications provided

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: November 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014