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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872196
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : April 1, 2013
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: ABT-072 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : April 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
1 - Follow-up Study
This is a follow-up study with no treatment and only samples being collected.
Drug: ABT-072
Blood samples are being taken from subjects previously treated with ABT-072.

Primary Outcome Measures :
  1. Analysis of the prevalence of resistance of specific mutations over time will be summarized. [ Time Frame: Approximately 48 weeks. ]
  2. 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. ]

Secondary Outcome Measures :
  1. Summary of serious adverse events related to study procedures only. [ Time Frame: Approximately 48 weeks. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872196

United States, California
Site Reference ID/Investigator# 18222
Los Angeles, California, United States, 90036
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Daniel Cohen, MD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00872196     History of Changes
Other Study ID Numbers: M10-605
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: April 1, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Hepatitis C
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases