Hepatitis CPhase 3NCT01773070

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 Phase 3 study testing ABT-450/ritonavir, ABT-333 and ABT-267 in people with Hepatitis C, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hepatitis C
What is being tested?: ABT-450/ritonavir, ABT-333 and ABT-267
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 478 participants
Where: No sites listed yet
Study dates: Jun 2013to Oct 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

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
Being tested: ABT-450/ritonavir, ABT-333, ABT-267
Keywords: Chronic Hepatitis C, Hepatitis C virus, Direct Acting Antiviral, Sustained Virologic Response, Hepatitis C, Persistence of treatment-emergent substitutions
Medical subject headings: Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-450/ritonavirDrug
Also called ABT-450 also known as paritaprevir
ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
ABT-333Drug
Also called dasabuvir
Drug is not administered -- this study is follow-up for participants previously receiving the drug.
ABT-267Drug
Also called ombitasvir
Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Study groups in NCT01773070
Study group	Role	What they receive
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. Receives: Drug: ABT-450/ritonavir; Drug: ABT-333; Drug: ABT-267

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: From the end of treatment through 12 weeks post-treatment
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.
Measured: From the end of treatment through 24 weeks post-treatment
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.
Measured: Up to 3 years post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Oct 2016

First posted23 Jan 2013 (estimated)
Study startJun 2013
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 478 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01773070
Sponsor's protocol ID: M13-102
Other IDs: 2012-003073-26
Status last verified: Nov 2017
First submitted: 19 Nov 2012
Last updated: 6 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
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RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01773070
Acronym / sponsor ID: M13-102
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C, Hepatitis C virus, Direct Acting Antiviral, Sustained Virologic Response, Hepatitis C, Persistence of treatment-emergent substitutions
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 478 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 23 Jan 2013 (estimated)
Results: Posted 6 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Participants	Other	Drug: ABT-450/ritonavir, Drug: ABT-333, Drug: ABT-267Participants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-450/ritonavirAlso: ABT-450 also known as paritaprevirABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.	Drug	All Participants
ABT-333Also: dasabuvirDrug is not administered -- this study is follow-up for participants previously receiving the drug.	Drug	All Participants
ABT-267Also: ombitasvirDrug is not administered -- this study is follow-up for participants previously receiving the drug.	Drug	All Participants

Primary outcome

Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection
Time frame: Up to 3 years post-treatment
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.
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B
Time frame: from the last dose of study drug in the previous study up to 3 years post-treatment
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.

3 secondary outcomes

Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection
Time frame: From the end of treatment through 12 weeks post-treatment
Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection
Time frame: From the end of treatment through 24 weeks post-treatment
Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection
Time frame: Up to 3 years post-treatment

Results and safety

Results posted to the registry on 6 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	478	397

Primary outcome: Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection

Time frame: Up to 3 years post-treatment. Number. Unit: percentage of participants

Measure	All Participants n = 457
Relapse12overall With New HCV Infection	0.2
Relapse12overall Without New HCV Infection	0.2

Population analysed: 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.

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

Time frame: from the last dose of study drug in the previous study up to 3 years post-treatment. Count of participants. Unit: Participants

Measure	All Participants n = 18
NS3: time of failure	7
NS3: post-treatment week 48	0
NS5A: time of failure	13
NS5A: post-treatment week 48	10
NS5A: post-treatment week 96	6
NS5A: post-treatment week 132	4
NS5B: time of failure	7
NS5B: post-treatment week 24	3

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From last dose of direct-acting antiviral agent treatment in the previous study to last HCV RNA assessment in M13-102 (mean [SD] duration: 146.3 [28.16] weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 478 (0%)	0 of 478 (0%)	3 of 478

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
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Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
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Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
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RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-450/ritonavir, ABT-333 and ABT-267 in people with Hepatitis C, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection (time frame: Up to 3 years post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01773070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017; AzTrials last refreshed its copy on 30 Oct 2026.