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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014