Text Size

This is Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00726882
First received: July 30, 2008
Last updated: January 15, 2013
Last verified: January 2013
History of Changes

July 30, 2008
January 15, 2013
August 2008
May 2010   (final data collection date for primary outcome measure)
  • 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 to ABT-333 compared to wild-type virus) will also be summarized. [ Time Frame: Approximately 48 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00726882 on ClinicalTrials.gov Archive Site
Summary of serious adverse events related to study procedures only. [ Time Frame: Approximately 48 weeks. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
This is Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies
A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-333 After Discontinuation of ABT-333 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-333 Clinical Studies

This is a follow up study for patients that participated in a previous ABT-333 study. There is no treatment provided and only blood samples for resistance are collected.

The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-333.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
HCV Infection
  • Procedure: Blood sample collection only
    Approximately monthly collection of blood samples
  • Drug: ABT-333
    Previous treatment in prior ABT-333 studies. Follow up study that includes sample collection procedures only and no treatment.
1
Follow-up study that includes sample collection procedures only and no treatment.
Interventions:
  • Procedure: Blood sample collection only
  • Drug: ABT-333
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Main Selection Criteria: Subject received ABT-333 or matching placebo in a prior clinical study involving ABT-333.
  • A subject will not be eligible for study participation 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.

Exclusion Criteria:

There is no exclusion criteria
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00726882
M10-459
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Daniel E Coihen, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP