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:
AbbVie (prior sponsor, Abbott)
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HCV Infection |
Procedure: Blood sample collection only Drug: ABT-333 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | 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 |
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 to ABT-333 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: | 35 |
| Study Start Date: | August 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Follow-up study that includes sample collection procedures only and no treatment.
|
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.
|
Detailed Description:
The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-333.
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: 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726882
Locations
| United States, California | |
| Site Reference ID/Investigator# 17665 | |
| Anaheim, California, United States, 92801 | |
| Site Reference ID/Investigator# 17367 | |
| Los Angeles, California, United States, 90036 | |
| Site Reference ID/Investigator# 17672 | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Site Reference ID/Investigator# 10381 | |
| Orlando, Florida, United States, 32803 | |
| United States, Louisiana | |
| Site Reference ID/Investigator# 17667 | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Texas | |
| Site Reference ID/Investigator# 14461 | |
| San Antonio, Texas, United States, 78215 | |
| Puerto Rico | |
| Site Reference ID/Investigator# 11141 | |
| Santurce, Puerto Rico, 00909 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Daniel E Coihen, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00726882 History of Changes |
| Other Study ID Numbers: | M10-459 |
| Study First Received: | July 30, 2008 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
HCV Infection |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections |
RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013