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 not yet open for participant recruitment.
Verified January 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01773070
First received: November 19, 2012
Last updated: January 18, 2013
Last verified: January 2013
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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 Abbott 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: | January 2013 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 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.
- 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.
Exclusion Criteria:
- The investigator considers the subject unsuitable for the study for any reasons.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773070
Contacts
| Contact: Melanie Gloria | 1-847-936-0714 | Melanie.Gloria@abbvie.com |
| Contact: Tiffany Larson, BS | 1-847-937-1338 | Tiffany.Larson@abbvie.com |
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: | January 18, 2013 |
| 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 C Hepatitis C, Chronic Hepatitis Hepatitis A Hepatitis, 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 May 16, 2013