A Follow-up Study to Assess Resistance to ABT-072 in HCV-... | NCT00872196

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

NCT00872196

Sponsor

AbbVie (prior sponsor, Abbott)

Status

Completed

Last Update Posted

Apr 1, 2013Estimated

Enrollment

5Actual

Phase

Phase 2

Conditions

Hepatitis C Virus Infection

Interventions

ABT-072

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Mar 23, 2009

First Submission Date that Met QC Criteria

Mar 27, 2009

First Posted Date

Mar 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 6, 2011

Certification/Extension First Submitted that Passed QC Review

Sep 6, 2011

Certification/Extension First Posted Date

Sep 12, 2011Estimated

Last Update Submitted Date

Mar 22, 2013

Last Update Posted Date

Apr 1, 2013Estimated

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 - Follow-up Study	Other	This is a follow-up study with no treatment and only samples being collected.	Drug: ABT-072

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABT-072	Drug	Blood samples are being taken from subjects previously treated with ABT-072.	1 - Follow-up Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Summary of serious adverse events related to study procedures only.		Approximately 48 weeks.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Cohen, MD	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 18222		Los Angeles	California	90036	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000625346	ABT-072

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided