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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01773070
First received: November 19, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 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 ClinicalTrials.gov identifier: NCT01773070

Contacts
Contact: Rebecca Craft, BS 1-901-854-2643 rebecca.craft@abbvie.com
Contact: Lia Hunter, PhD +44 (0)208 761 7684 lia.hunter@abbvie.com

  Show 135 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Eoin Coakley, MD AbbVie
  More Information

No publications provided

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: July 21, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014