A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies
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
1 other identifier
interventional
5
1 country
1
Brief Summary
This is a follow-up study with no treatment and only samples being collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 1, 2013
January 1, 2013
1 year
March 23, 2009
March 22, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Analysis of the prevalence of resistance of specific mutations over time will be summarized.
Approximately 48 weeks.
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.
Secondary Outcomes (1)
Summary of serious adverse events related to study procedures only.
Approximately 48 weeks.
Study Arms (1)
1 - Follow-up Study
OTHERThis is a follow-up study with no treatment and only samples being collected.
Interventions
Blood samples are being taken from subjects previously treated with ABT-072.
Eligibility Criteria
You may qualify if:
- \- Main Selection Criteria: A subject that has received either ABT-072 or placebo in a prior study involving ABT-072.
You may not qualify 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 a prior ABT-072 clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site Reference ID/Investigator# 18222
Los Angeles, California, 90036, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Cohen, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 31, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 1, 2013
Record last verified: 2013-01