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

Hepatitis C Virus Infection Clinical Trial

Official title:

A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-072 After Discontinuation of ABT-072 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-072 Clinical Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872196
• Other study ID #: M10-605
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2009
• Last updated: March 22, 2013
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 18222	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the prevalence of resistance of specific mutations over time will be summarized.		Approximately 48 weeks.	Yes
Primary	Analysis of the degree of phenotypic resistance (fold change in susceptibility of ABT-072 compared to wild-type virus) will also be summarized.		Approximately 48 weeks.	Yes
Secondary	Summary of serious adverse events related to study procedures only.		Approximately 48 weeks.	Yes