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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773070
First Posted: January 23, 2013
Last Update Posted: December 6, 2017
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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).

Condition Intervention Phase
Hepatitis C Drug: ABT-450/ritonavir Drug: ABT-333 Drug: ABT-267 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 478
Study Start Date: June 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773070


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: AbbVie Inc AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01773070     History of Changes
Other Study ID Numbers: M13-102
2012-003073-26 ( EudraCT Number )
First Submitted: November 19, 2012
First Posted: January 23, 2013
Results First Submitted: October 5, 2017
Results First Posted: November 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Chronic Hepatitis C
Hepatitis C virus
Direct Acting Antiviral
Sustained Virologic Response
Hepatitis C
Persistence of treatment-emergent substitutions

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors