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

Phase 2

Completed

• Conditions: HCV Infection
• Interventions: Procedure: Blood sample collection only; Drug: ABT-333

• Registration Number: NCT00726882
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Study Timeline

• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study Start: 2008-08
• Study First Posted: 2008-08-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Disposition First Submitted: 2011-09-21
• Disposition First Submitted QC: 2011-09-21
• Disposition First Posted: 2011-10-05
• Status Verified: 2014-12
• Results First Submitted: 2014-12-29
• Results First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Results First Posted: 2015-01-08
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCV-infected Participants	Blood sample collection only	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.
HCV-infected Participants	ABT-333	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.

Primary Outcome Measures

Name	Time	Method
Persistence of Resistance-Associated Variants and Phenotypic Resistance	Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks	Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events Related to Study Procedures	48 weeks	Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.

Trial Locations

Locations (7)

Site Reference ID/Investigator# 17672; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 17665; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 10381; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 17367; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 17667; 🇺🇸 Baton Rouge, Louisiana, United States

Site Reference ID/Investigator# 11141; 🇵🇷 Santurce, Puerto Rico

Site Reference ID/Investigator# 14461; 🇺🇸 San Antonio, Texas, United States