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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00872196
First received: March 23, 2009
Last updated: March 22, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Hepatitis C Virus Infection
Drug: ABT-072
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Analysis of the prevalence of resistance of specific mutations 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 ]

Enrollment: 5
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (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.
Drug: ABT-072
Blood samples are being taken from subjects previously treated with ABT-072.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, California
Site Reference ID/Investigator# 18222
Los Angeles, California, United States, 90036
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Daniel Cohen, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00872196     History of Changes
Other Study ID Numbers: M10-605
Study First Received: March 23, 2009
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014