Chronic Hepatitis C Virus (HCV)Phase 3NCT02517528

ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and ribavirin in people with Chronic Hepatitis C Virus (HCV), 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 is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis C Virus (HCV)
What is being tested?: ABT-450/r/ABT-267, ABT-333 and ribavirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: No sites listed yet
Study dates: 20 Jul 2015to 16 Mar 2017
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
Chronic HCV-infection prior to study enrollment.
Screening laboratory result indicating HCV genotype 1b-infection.
Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
Per local standard practice, documentation of cirrhosis by one of the following methods:
Diagnosis on previous liver biopsy or liver biopsy conducted during screening e.g., Metavir Score of > 3 (including 3/4 or 3 - 4), Ishak score of > 4 or,
FibroScan score ≥ 14.6 kiloPascals (kPa) within 6 months of Screening or during the Screening Period.

Who cannot join

HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result should be confirmed with CT scan or MRI.)

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Any primary cause of liver disease other than chronic HCV-infection, including but not limited to the following:
Hemochromatosis
Alpha-1 antitrypsin deficiency
Wilson's disease
Autoimmune hepatitis
Alcoholic liver disease
Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy coincident with HCV-related changes would not be considered exclusionary unless the steatohepatitis is considered to be the primary cause of the liver disease.
Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

About this study

Official title: An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

Conditions: Chronic Hepatitis C Virus (HCV)
Being tested: ABT-450/r/ABT-267, ABT-333, ribavirin
Keywords: HCV Infection, Compensated Cirrhosis
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

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

ABT-450/r/ABT-267Drug
Also called ombitasvir/paritaprevir/ritonavir, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
Tablet
ABT-333Drug
Also called dasabuvir
Tablet
ribavirinDrug
Tablet

Study groups in NCT02517528
Study group	Role	What they receive
ABT-450/r/ABT-267 + ABT-333 + Ribavirin	Experimental	ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks Receives: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: ribavirin

What is being measured

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

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority.
Measured: 12 weeks after last dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China.
Measured: 24 weeks after last dose of study drug

Secondary outcomes (3)

Percentage of Participants With On Treatment Virologic Failure
On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method.
Measured: Within 12 weeks after first dose of study drug
Percentage of Participants With Virologic Relapse
Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method.
Measured: Within 12 weeks after the last dose of study drug
Percentage of Participants With Virologic Relapse by Post-Treatment Week 24
Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method.
Measured: Within 24 weeks after the last 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.

20 Jul 201516 Mar 2017

First posted7 Aug 2015 (estimated)
Study start20 Jul 2015
Primary completion29 Sep 2016
Study completion16 Mar 2017

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 Chronic Hepatitis C Virus (HCV)Studies 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: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02517528
Sponsor's protocol ID: M14-491
Status last verified: Jan 2018
First submitted: 5 Aug 2015
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8.
PubMed 29909549

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
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C Virus (HCV) trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
ClinicalTrials.gov ID: NCT02517528
Acronym / sponsor ID: M14-491
Conditions: Chronic Hepatitis C Virus (HCV)
Keywords: HCV Infection, Compensated Cirrhosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 20 Jul 2015 (actual)
Primary completion: 29 Sep 2016 (actual)
Study completion: 16 Mar 2017 (actual)
First posted: 7 Aug 2015 (estimated)
Results: Posted 9 Oct 2018

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
ABT-450/r/ABT-267 + ABT-333 + Ribavirin	Experimental	Drug: ABT-450/r/ABT-267, Drug: ABT-333, Drug: ribavirinABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
Chronic HCV-infection prior to study enrollment.
Screening laboratory result indicating HCV genotype 1b-infection.
Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
Per local standard practice, documentation of cirrhosis by one of the following methods:

Key exclusion criteria (14 listed)

HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-Human Immunodeficiency virus antibody (HIV Ab).
Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.

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/r/ABT-267Also: ombitasvir/paritaprevir/ritonavir, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450Tablet	Drug	ABT-450/r/ABT-267 + ABT-333 + Ribavirin
ABT-333Also: dasabuvirTablet	Drug	ABT-450/r/ABT-267 + ABT-333 + Ribavirin
ribavirinTablet	Drug	ABT-450/r/ABT-267 + ABT-333 + Ribavirin

Primary outcome

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
Time frame: 12 weeks after last dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
Time frame: 24 weeks after last dose of study drug
SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China.

3 secondary outcomes

Percentage of Participants With On Treatment Virologic Failure
Time frame: Within 12 weeks after first dose of study drug
Percentage of Participants With Virologic Relapse
Time frame: Within 12 weeks after the last dose of study drug
Percentage of Participants With Virologic Relapse by Post-Treatment Week 24
Time frame: Within 24 weeks after the last dose of study drug

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABT-450/r/ABT-267 + ABT-333 + Ribavirin	104	103

Primary outcome: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)

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

Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n = 104
Value	100 (96.4 to 100.0)

Population analysed: Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures.

Primary outcome: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)

Time frame: 24 weeks after last dose of study drug. Number (95% Confidence Interval). Unit: percentage of participants

Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n = 104
Value	100 (96.4 to 100.0)

Population analysed: Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT-450/r/ABT-267 + ABT-333 + Ribavirin	4 of 104 (3.8%)	71 of 104 (68.3%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29909549Zha J, Ding B, Wang H, Zhao W, Yu C, Alves K, Mobashery N, Luo Y, Menon RM. Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients. Eur J Drug Metab Pharmacokinet. 2019 Feb;44(1):43-52. doi: 10.1007/s13318-018-0492-8.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Hepatitis C Virus (HCV)

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational 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.

AbbVie Inc. study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and ribavirin in people with Chronic Hepatitis C Virus (HCV), 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 7 inclusion and 14 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 9 Oct 2018. 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 9 Oct 2018). 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 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) (time frame: 12 weeks after last dose of study drug). 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 NCT02517528, 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 9 Oct 2018.