Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With 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: March 31, 2014
Last verified: March 2014
  Purpose

This three-year multicenter study is being done to follow participants who received at least one dose of 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: MK-5172

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 MK-5172 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 MK-5172 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
MK-5172
Participants previously received MK-5172 as study treatment.
Drug: MK-5172
MK-5172 was not administered to participants in the course of this study.
Other Name: Participants previously received study treatment with MK-5172 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 MK-5172 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 MK-5172 protocol and received at least one dose of MK-5172
  • Must enroll in the present study within one year of the treatment portion of the previous MK-5172 protocol except in the circumstance where the previous protocol has a follow-up period ≥1 year

Exclusion Criteria:

  • None
  Contacts and Locations
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: March 31, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014