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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
First received: November 19, 2012
Last updated: April 14, 2016
Last verified: April 2016
A follow up study designed to obtain long term data on subjects who either achieved a sustained virologic response or did not achieve a sustained virologic response in an Abbott sponsored hepatitis C study.

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: Open Label
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:

Primary Outcome Measures:
  • Durability of treatment response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate the persistence of specific hepatitis C amino acid variants associated with drug resistance in subjects who experience virologic failure.

Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Follow-up study that includes sample collection procedures only and no treatment.
Drug: ABT-450/ritonavir
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.
Drug: ABT-333
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.
Drug: ABT-267
Drug is not administered -- this study is follow-up for subjects previously receiving the drug.

Detailed Description:

A follow-up study to assess resistance and durability of response to three experimental drugs ABT-450/r, ABT-267, and ABT-333 in subjects who have participated in Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C.

The other primary purpose of the study is to assess for durability of treatment response and assess for drug resistance.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior Abbott HCV Phase 2 or 3 study which is being submitted as a US IND.
  • The interval between the last dose of the Abbott Direct-Acting Antiviral Agent 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01773070

  Show 89 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Mariem Charafeddine, MD AbbVie
  More Information

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01773070     History of Changes
Other Study ID Numbers: M13-102  2012-003073-26 
Study First Received: November 19, 2012
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Chronic Hepatitis C
Hepatitis C virus
Direct Acting Antiviral
Sustained Virologic Response
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 30, 2016