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

This study is enrolling participants by invitation only.

First Received: March 23, 2009 Last Updated: April 23, 2009 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00872196

Purpose

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

Condition	Intervention	Phase
Hepatitis C Virus Infection	Procedure: Blood sample collection	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment

Further study details as provided by Abbott:

Primary Outcome Measures:

Analysis of the prevalence of resistance of specific over time will be summarized. [ Time Frame: Approximately 48 weeks. ] [ Designated as safety issue: Yes ]
Analysis of the degree of phenotypic resistance (fold change in susceptibility of ABT-072 compared to wild-type virus) will also be summarized. [ Time Frame: Approximately 48 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Summary of serious adverse events related to study procedures only. [ Time Frame: Approximately 48 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	68
Study Start Date:	March 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 - Follow-up Study This is a follow-up study with no treatment and only samples being collected.	Procedure: Blood sample collection Approximately monthly blood collections through a 48 week time period.

Detailed Description:

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

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872196

Locations

United States, Illinois

Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott Laboratories ( Daniel Cohen )
Study ID Numbers:	M10-605
Study First Received:	March 23, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00872196 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases

Digestive System Diseases
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C
Infection

ClinicalTrials.gov processed this record on May 07, 2009