Clinical trial NCT00726882: 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
Official title: A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-333 After Discontinuation of ABT-333 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-333 Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HCV Infection
Keywords: HCV Infection
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Persistence of Resistance-Associated Variants and Phenotypic Resistance
timeFrame: Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events Related to Study Procedures
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 17665
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 17367
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 17672
state: California
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 10381
state: Florida
city: Baton Rouge
country: United States
facility: Site Reference ID/Investigator# 17667
state: Louisiana
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 14461
state: Texas
city: Santurce
country: Puerto Rico
facility: Site Reference ID/Investigator# 11141
Study officials:
affiliation: AbbVie
name: Daniel E Cohen, MD
role: STUDY_DIRECTOR
References: