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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 has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: November 19, 2012
Last updated: October 25, 2016
Last verified: October 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: None (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 ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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.

Enrollment: 479
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
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 identifier: NCT01773070

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

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01773070     History of Changes
Other Study ID Numbers: M13-102
2012-003073-26 ( EudraCT Number )
Study First Received: November 19, 2012
Last Updated: October 25, 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Chronic Hepatitis C
Hepatitis C virus
Direct Acting Antiviral
Sustained Virologic Response
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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 processed this record on September 21, 2017