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

NCT00726882 | Completed Phase 2 Results

• 1 other identifier: M10-459
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 7

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).

Conditions

HCV Infection

Keywords

HCV Infection

Outcome Measures

Primary Outcomes (1)

• Persistence of Resistance-Associated Variants and Phenotypic Resistance

  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.

  Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks

Secondary Outcomes (1)

• Number of Participants With Serious Adverse Events Related to Study Procedures

  48 weeks

Study Arms (1)

HCV-infected Participants

OTHER

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.

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

Interventions

Blood sample collection only PROCEDURE

Approximately monthly collection of blood samples.

HCV-infected Participants

ABT-333 DRUG

Previous treatment in prior ABT-333 studies.

Also known as: dasabuvir

HCV-infected Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (7)

Site Reference ID/Investigator# 17665

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 17367

Los Angeles, California, 90036, United States

Location

Site Reference ID/Investigator# 17672

Los Angeles, California, 90048, United States

Location

Site Reference ID/Investigator# 10381

Orlando, Florida, 32803, United States

Location

Site Reference ID/Investigator# 17667

Baton Rouge, Louisiana, 70808, United States

Location

Site Reference ID/Investigator# 14461

San Antonio, Texas, 78215, United States

Location

Site Reference ID/Investigator# 11141

Santurce, 00909, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C

Interventions

dasabuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Daniel E Cohen, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 1, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2014-12

Locations

PR (1); US (6)