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A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies

Phase 2
Completed
Conditions
Hepatitis C Virus Infection
Interventions
Registration Number
NCT00872196
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Brief Summary

This is a follow-up study with no treatment and only samples being collected.

Detailed Description

The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-072.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5
Inclusion Criteria
  • Main Selection Criteria: A subject that has received either ABT-072 or placebo in a prior study involving ABT-072.
Exclusion Criteria
  • The investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in a prior ABT-072 clinical study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1 - Follow-up StudyABT-072This is a follow-up study with no treatment and only samples being collected.
Primary Outcome Measures
NameTimeMethod
Analysis of the prevalence of resistance of specific mutations over time will be summarized.Approximately 48 weeks.
Analysis of the degree of phenotypic resistance (fold change in susceptibility of ABT-072 compared to wild-type virus) will also be summarized.Approximately 48 weeks.
Secondary Outcome Measures
NameTimeMethod
Summary of serious adverse events related to study procedures only.Approximately 48 weeks.

Trial Locations

Locations (1)

Site Reference ID/Investigator# 18222

🇺🇸

Los Angeles, California, United States

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