A 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: December 29, 2014
Last verified: December 2014
  Purpose

The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).


Condition Intervention Phase
HCV Infection
Procedure: Blood sample collection only
Drug: ABT-333
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-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:
  • Persistence of Resistance-Associated Variants and Phenotypic Resistance [ Time Frame: Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks ] [ Designated as safety issue: No ]
    Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.


Secondary Outcome Measures:
  • Number of Participants With Serious Adverse Events Related to Study Procedures [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.


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
HCV-infected Participants

Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.

Participants received no treatment in this follow-up study.

Procedure: Blood sample collection only
Approximately monthly collection of blood samples.
Drug: ABT-333
Previous treatment in prior ABT-333 studies.
Other Name: dasabuvir

Detailed Description:

This Phase 2, multicenter study was conducted in HCV-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333. Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in Study M10-351 Substudy 2 (NCT00696904; ABT-333 dosing duration was 2 days) and Study M10-380 (NCT00851890; ABT-333 dosing duration was 28 days) were eligible.

After receiving at least 1 dose of ABT-333 or placebo, subjects were assessed for participation in this rollover study and asked to review the informed consent. The day of study completion or early discontinuation from the prior ABT-333 clinical study served as the baseline assessment. If it was found that a participant received placebo during the previous ABT-333 clinical study, the sites were instructed to discontinue the participant from this study.

This study included approximately monthly blood sample collection procedures for 48 weeks, and no treatment was provided during this time.

  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.

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 prior ABT-333 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: 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 Cohen, MD AbbVie
  More Information

Additional 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
Results First Received: December 29, 2014
Last Updated: December 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
HCV Infection

ClinicalTrials.gov processed this record on May 29, 2015