A Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies

AbbVie

Status and phase: Completed; Phase 2

Conditions: HCV Infection

Treatments: Procedure: Blood sample collection only; Drug: ABT-333

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726882

M10-459

Details and patient eligibility

About

The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).

Full description

This Phase 2, multicenter study was conducted in HCV-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in Study M10-351 Substudy 2 (NCT00696904; ABT-333 dosing duration was 2 days) and Study M10-380 (NCT00851890; ABT-333 dosing duration was 28 days) were eligible.

After receiving at least 1 dose of ABT-333 or placebo, subjects were assessed for participation in this rollover study and asked to review the informed consent. The day of study completion or early discontinuation from the prior ABT-333 clinical study served as the baseline assessment. If it was found that a participant received placebo during the previous ABT-333 clinical study, the sites were instructed to discontinue the participant from this study.

This study included approximately monthly blood sample collection procedures for 48 weeks, and no treatment was provided during this time.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Main Selection Criteria: Subject received ABT-333 or matching placebo in a prior clinical study involving ABT-333.

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 prior ABT-333 clinical study.

Trial design

35 participants in 1 patient group

HCV-infected Participants

Other group

Description:

Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Participants received no treatment in this follow-up study.

Treatment:

Drug: ABT-333

Procedure: Blood sample collection only