Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01773070
Enrollment
478
Registered
2013-01-23
Start date
2013-06-30
Completion date
2016-10-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

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

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).

Interventions

DRUGABT-450/ritonavir

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

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

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

Sponsors

AbbVie (prior sponsor, Abbott)
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Experienced Relapse12overall With and Without New HCV InfectionUp to 3 years post-treatmentRelapse 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.
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5Bfrom the last dose of study drug in the previous study up to 3 years post-treatmentThe 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.

Secondary

MeasureTime frameDescription
Percentage of Participants Who Experienced Relapse12 Without and With New HCV InfectionFrom the end of treatment through 12 weeks post-treatmentRelapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.
Percentage of Participants Who Experienced Relapse24 Without and With New HCV InfectionFrom the end of treatment through 24 weeks post-treatmentRelapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.
Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV InfectionUp to 3 years post-treatmentRelapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

Participant flow

Recruitment details

This follow-up study was open to participants from AbbVie studies 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).

Participants by arm

ArmCount
All Participants
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.
478
Total478

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath (unrelated to study procedures)3
Overall StudyLost to Follow-up39
Overall StudyOther15
Overall StudyWithdrawal by Subject24

Baseline characteristics

CharacteristicAll Participants
Age, Continuous53.0 years
STANDARD_DEVIATION 9.85
Sex: Female, Male
Female
227 Participants
Sex: Female, Male
Male
251 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
3 / 478
other
Total, other adverse events
0 / 478
serious
Total, serious adverse events
0 / 478

Outcome results

Primary

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.

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

Population: GT1a-infected participants who experienced virologic failure after receiving ABT-450, ABT-333 or ABT-267, and had not achieved SVR12 and had post-baseline sequencing data for NS3, NS5A, or NS5B at given time point.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5B: time of failure7 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS3: time of failure7 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS3: post-treatment week 480 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5A: time of failure13 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5A: post-treatment week 4810 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5A: post-treatment week 966 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5A: post-treatment week 1324 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5B: post-treatment week 243 Participants
All ParticipantsNumber of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5BNS5B: post-treatment week 961 Participants
Primary

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.

Time frame: Up to 3 years post-treatment

Population: Participants who achieved SVR12 and had post-SVR12 HCV RNA data available. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

ArmMeasureGroupValue (NUMBER)
All ParticipantsPercentage of Participants Who Experienced Relapse12overall With and Without New HCV InfectionRelapse12overall With New HCV Infection0.2 percentage of participants
All ParticipantsPercentage of Participants Who Experienced Relapse12overall With and Without New HCV InfectionRelapse12overall Without New HCV Infection0.2 percentage of participants
Secondary

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

Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

Time frame: From the end of treatment through 12 weeks post-treatment

Population: Participants with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

ArmMeasureGroupValue (NUMBER)
All ParticipantsPercentage of Participants Who Experienced Relapse12 Without and With New HCV InfectionRelapse12 Without New HCV Infection2.0 percentage of participants
All ParticipantsPercentage of Participants Who Experienced Relapse12 Without and With New HCV InfectionRelapse12 With New HCV Infection0 percentage of participants
Secondary

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

Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.

Time frame: From the end of treatment through 24 weeks post-treatment

Population: Participants who achieved SVR12 and had HCV RNA data available in the SVR24 window. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

ArmMeasureGroupValue (NUMBER)
All ParticipantsPercentage of Participants Who Experienced Relapse24 Without and With New HCV InfectionRelapse24 With New HCV Infection0 percentage of participants
All ParticipantsPercentage of Participants Who Experienced Relapse24 Without and With New HCV InfectionRelapse24 Without New HCV Infection0.2 percentage of participants
Secondary

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

Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

Time frame: Up to 3 years post-treatment

Population: Participants with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

ArmMeasureGroupValue (NUMBER)
All ParticipantsPercentage of Participants Who Experienced Relapse˅Overall Without and With New HCV InfectionRelapse˅overall Without New HCV Infection2.2 percentage of participants
All ParticipantsPercentage of Participants Who Experienced Relapse˅Overall Without and With New HCV InfectionRelapse˅overall With New HCV Infection0.2 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026