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Trial record 2 of 126 for:    abbvie hcv

A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01773070
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : November 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE January 23, 2013
Results First Submitted Date  ICMJE October 5, 2017
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date December 6, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection [ Time Frame: Up to 3 years post-treatment ]
    Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.
  • Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B [ Time Frame: from the last dose of study drug in the previous study up to 3 years post-treatment ]
    The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • Durability of treatment response [ Time Frame: Up to 3 years ]
    The percentage of subjects who relapse or have new hepatitis C infection at any time up to the last follow-up in this study out of subjects who achieved a 12-week Post-treatment sustained virologic response in the previous study and enroll in this study.
  • Persistence of resistance mutations [ Time Frame: Up to 3 years ]
    Evaluate the persistence of specific hepatitis C amino acid variants associated with drug resistance in subjects who experience virologic failure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection [ Time Frame: From the end of treatment through 12 weeks post-treatment ]
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.
  • Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection [ Time Frame: From the end of treatment through 24 weeks post-treatment ]
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.
  • Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection [ Time Frame: Up to 3 years post-treatment ]
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
Official Title  ICMJE A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Brief Summary A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: ABT-450/ritonavir
    ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
    Other Name: ABT-450 also known as paritaprevir
  • Drug: ABT-333
    Drug is not administered -- this study is follow-up for participants previously receiving the drug.
    Other Name: dasabuvir
  • Drug: ABT-267
    Drug is not administered -- this study is follow-up for participants previously receiving the drug.
    Other Name: ombitasvir
Study Arms  ICMJE All Participants
Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Interventions:
  • Drug: ABT-450/ritonavir
  • Drug: ABT-333
  • Drug: ABT-267
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2017)
478
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)
500
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
  • The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
  • The subject must voluntarily sign and date the informed consent form.
  • Subject completed the post-treatment period of an eligible prior study.

Exclusion Criteria:

  • The investigator considers the subject unsuitable for the study for any reasons.
  • Receipt of any investigational product from Day 1 and while enrolled in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Belgium,   Canada,   Denmark,   Germany,   Ireland,   Netherlands,   New Zealand,   Puerto Rico,   Spain,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01773070
Other Study ID Numbers  ICMJE M13-102
2012-003073-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc AbbVie
PRS Account AbbVie
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP