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

AbbVie (prior sponsor, Abbott)5 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus Infection

Interventions

ABT-072DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Site Reference ID/Investigator# 18222

Los Angeles, California, United States

Outcomes

Primary Outcomes

Analysis of the prevalence of resistance of specific mutations over time will be summarized.

Time frame: 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.

Time frame: Approximately 48 weeks.

Secondary Outcomes

Summary of serious adverse events related to study procedures only.

Time frame: Approximately 48 weeks.

Data from ClinicalTrials.gov

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