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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

A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-072 After Discontinuation of ABT-072 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-072 Clinical Studies

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00872196
Enrollment
5
Registered
2009-03-31
Start date
2009-04-30
Completion date
2010-04-30
Last updated
2013-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus Infection

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.

Interventions

Blood samples are being taken from subjects previously treated with ABT-072.

Sponsors

AbbVie (prior sponsor, Abbott)
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Summary of serious adverse events related to study procedures only.Approximately 48 weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026