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

NCT01773070 | Completed Phase 3 Results

• 2 other identifiers: M13-1022012-003073-26
• Study Type: interventional
• Target: 478
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Hepatitis C

Keywords

Chronic Hepatitis C; Hepatitis C virus; Direct Acting Antiviral; Sustained Virologic Response; Hepatitis C; Persistence of treatment-emergent substitutions

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection

  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.

  Up to 3 years post-treatment

• Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B

  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.

  from the last dose of study drug in the previous study up to 3 years post-treatment

Secondary Outcomes (3)

• Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection

  From the end of treatment through 12 weeks post-treatment

• Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection

  From the end of treatment through 24 weeks post-treatment

• Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection

  Up to 3 years post-treatment

Study Arms (1)

All Participants

OTHER

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; Drug: ABT-333; Drug: ABT-267

Interventions

ABT-450/ritonavir DRUG

ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Also known as: ABT-450 also known as paritaprevir

All Participants

ABT-333 DRUG

Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Also known as: dasabuvir

All Participants

ABT-267 DRUG

Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Also known as: ombitasvir

All Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

paritaprevir; dasabuvir; ombitasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor Abbott)

800-633-9110

Study Officials

• AbbVie Inc

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: January 23, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-11