Hepatitis C InfectionPhase 3GARNETNCT02582632

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir in people with Hepatitis C Infection and Hepatitis C Virus, run by AbbVie.

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

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV). Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Hepatitis C Infection, Hepatitis C Virus
What is being tested?: ombitasvir/paritaprevir/ritonavir and dasabuvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: No sites listed yet
Study dates: 24 Nov 2015to 1 Dec 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 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic HCV infection at Screening.
Screening laboratory result indicating HCV genotype 1b infection.
Treatment-naïve and non-cirrhotic.

Who cannot join

HCV genotype or subtype other than GT1b.
Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
Any current or past clinical evidence of cirrhosis.
Screening laboratory analyses that shows abnormal results.
Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

About this study

Official title: An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

Conditions: Hepatitis C Infection, Hepatitis C Virus
Being tested: ombitasvir/paritaprevir/ritonavir, dasabuvir
Keywords: Hepatitis C Virus, Interferon-Free, Ribavirin-Free, Hepatitis C, Hepatitis C Genotype 1b
Medical subject headings: Hepatitis C

What participants receive

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

ombitasvir/paritaprevir/ritonavirDrug
Also called ABT-267/ABT-450/r, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
Tablet
dasabuvirDrug
Also called ABT-333
Tablet

Study groups in NCT02582632
Study group	Role	What they receive
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	Experimental	Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks Receives: Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir

What is being measured

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

Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (4)

Percentage of Participants With On-Treatment Virologic Failure During Treatment Period
On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.
Measured: Up to 8 weeks while on treatment
Percentage of Participants With Post-Treatment Relapse12
Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.
Measured: Up to 12 weeks after last dose of study drug
Percentage of Female Participants Responding With SVR12
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Measured: 12 weeks after the last actual dose of study drug
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Measured: Baseline and 12 weeks after the last actual dose of study drug

Timeline

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

24 Nov 20151 Dec 2016

First posted21 Oct 2015 (estimated)
Study start24 Nov 2015
Primary completion24 Aug 2016
Study completion1 Dec 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02582632
Sponsor's protocol ID: M15-684
Other IDs: 2015-003370-33, 2015
Acronym: GARNET
Status last verified: Jul 2021
First submitted: 20 Oct 2015
Last updated: 30 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.
PubMed 28416221

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

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
ClinicalTrials.gov ID: NCT02582632
Acronym / sponsor ID: GARNET / M15-684
Conditions: Hepatitis C Infection, Hepatitis C Virus
Keywords: Hepatitis C Virus, Interferon-Free, Ribavirin-Free, Hepatitis C, Hepatitis C Genotype 1b
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 24 Nov 2015
Primary completion: 24 Aug 2016 (actual)
Study completion: 1 Dec 2016 (actual)
First posted: 21 Oct 2015 (estimated)
Results: Posted 13 Dec 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	Experimental	Drug: ombitasvir/paritaprevir/ritonavir, Drug: dasabuvirOmbitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Chronic HCV infection at Screening.
Screening laboratory result indicating HCV genotype 1b infection.
Treatment-naïve and non-cirrhotic.

Key exclusion criteria (5 listed)

HCV genotype or subtype other than GT1b.
Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
Any current or past clinical evidence of cirrhosis.
Screening laboratory analyses that shows abnormal results.
Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for 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
ombitasvir/paritaprevir/ritonavirAlso: ABT-267/ABT-450/r, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450Tablet	Drug	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
dasabuvirAlso: ABT-333Tablet	Drug	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

Primary outcome

Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after the last actual dose of study drug
SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

4 secondary outcomes

Percentage of Participants With On-Treatment Virologic Failure During Treatment Period
Time frame: Up to 8 weeks while on treatment
Percentage of Participants With Post-Treatment Relapse12
Time frame: Up to 12 weeks after last dose of study drug
Percentage of Female Participants Responding With SVR12
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
Time frame: Baseline and 12 weeks after the last actual dose of study drug

Results and safety

Results posted to the registry on 13 Dec 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
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	166	165

Primary outcome: Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Time frame: 12 weeks after the last actual dose of study drug. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir n = 166
Value	97.6 (95.3 to 99.9)

Population analysed: Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir	2 of 166 (1.2%)	70 of 166 (42.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28416221Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.

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Not yet recruitingObservational study
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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.

Emily Dumas, PhD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir in people with Hepatitis C Infection and Hepatitis C Virus, run by AbbVie.

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 3 inclusion and 5 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 30 Jul 2021. 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 13 Dec 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 Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of study drug). 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 NCT02582632, which also lists 1 linked publication.

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 30 Jul 2021.