Hepatitis C Virus (HCV)Phase 3NCT02517515

ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir in people with 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 study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C Virus (HCV)
What is being tested?: ombitasvir/paritaprevir/ritonavir and dasabuvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 650 participants
Where: No sites listed yet
Study dates: Jul 2015to Jun 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 hepatitis C virus (HCV) infection prior to study enrollment.
Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
Per local standard practice, documented absence of cirrhosis.
Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.

Who cannot join

HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
Any current or past clinical evidence of cirrhosis.
Any primary cause of liver disease other than chronic HCV infection.
Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Conditions: Hepatitis C Virus (HCV)
Being tested: ombitasvir/paritaprevir/ritonavir and dasabuvir, Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Keywords: HCV Infection, Chronic Hepatitis C Virus, Hepatitis C Virus (HCV) Genotype 1b
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.

ombitasvir/paritaprevir/ritonavir and dasabuvirDrug
Also called Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvirDrug
Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Study groups in NCT02517515
Study group	Role	What they receive
Double-blind 3-DAA	Experimental	Double-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
Double-blind Placebo Followed by Open-label 3-DAA	Experimental	Double-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

What is being measured

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

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.
Measured: 12 weeks after the last actual dose of active study drug
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.
Measured: 24 weeks after the last actual dose of active study drug

Secondary outcomes (3)

Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment.
Measured: up to 12 weeks
Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: From the end of treatment through 12 weeks after the last dose of active study drug
Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: From the end of treatment through 24 weeks after the last dose of active study drug

Timeline

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

Jul 2015Jun 2017

First posted7 Aug 2015 (estimated)
Study startJul 2015
Primary completionOct 2016
Study completionJun 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 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 650 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02517515
Sponsor's protocol ID: M13-767
Status last verified: Sep 2017
First submitted: 5 Aug 2015
Last updated: 27 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov ID: NCT02517515
Acronym / sponsor ID: M13-767
Conditions: Hepatitis C Virus (HCV)
Keywords: HCV Infection, Chronic Hepatitis C Virus, Hepatitis C Virus (HCV) Genotype 1b
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 650 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Jul 2015 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Jun 2017 (actual)
First posted: 7 Aug 2015 (estimated)
Results: Posted 27 Oct 2017

Clinical summary

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

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Double-blind 3-DAA	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvirDouble-blind 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
Double-blind Placebo Followed by Open-label 3-DAA	Experimental	Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir, Drug: Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvirDouble-blind placebo for 12 weeks, followed by open-label 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg 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 (6 listed)

Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
Chronic hepatitis C virus (HCV) infection prior to study enrollment.
Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
Per local standard practice, documented absence of cirrhosis.
Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser

Key exclusion criteria (6 listed)

HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
Any current or past clinical evidence of cirrhosis.
Any primary cause of liver disease other than chronic HCV infection.
Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

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/ritonavir and dasabuvirAlso: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet	Drug	Double-blind 3-DAA, Double-blind Placebo Followed by Open-label 3-DAA
Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvirPlacebo for ombitasvir/paritaprevir/ritonavir and dasabuvir	Drug	Double-blind Placebo Followed by Open-label 3-DAA

Primary outcome

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after the last actual dose of active study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)
Time frame: 24 weeks after the last actual dose of active study drug
SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.

3 secondary outcomes

Percentage of Participants With On-treatment Virologic Failure
Time frame: up to 12 weeks
Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12
Time frame: From the end of treatment through 12 weeks after the last dose of active study drug
Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24
Time frame: From the end of treatment through 24 weeks after the last dose of active study drug

Results and safety

Results posted to the registry on 27 Oct 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
Double-blind 3-DAA	325	323
Double-blind Placebo Followed by Open-label 3-DAA	325	323

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

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

Measure	Double-blind 3-DAA (Treatment-Naïve) n = 184	Double-blind 3-DAA (Treatment-Experienced) n = 141
Value	99.5 (97.0 to 99.9)	100 (97.4 to 100.0)

Double-blind 3-DAA (Treatment-Naïve): percentage of participants: 99.5 (95% CI 97.0 to 99.9)
Double-blind 3-DAA (Treatment-Experienced): percentage of participants: 100 (95% CI 97.4 to 100.0)

Population analysed: All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.

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

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

Measure	Double-blind 3-DAA (Treatment-Naïve) n = 184	Double-blind 3-DAA (Treatment-Experienced) n = 141
Value	99.5 (97.0 to 99.9)	100 (97.4 to 100.0)

Double-blind 3-DAA (Treatment-Naïve): percentage of participants: 99.5 (95% CI 97.0 to 99.9)
Double-blind 3-DAA (Treatment-Experienced): percentage of participants: 100 (95% CI 97.4 to 100.0)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) for the double-blind (DB) period were collected from first dose of DB study drug until 30 days after the last dose of DB study drug or until the first dose of open-label (OL) study drug for those entering the OL period (up to 16 weeks). TEAEs and TESAEs for the OL period were collected from the first dose of OL study drug until 30 days after the last dose of OL study drug (up to 16 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind 3-DAA	7 of 325 (2.2%)	72 of 325 (22.2%)	Not reported
Double-blind Placebo	2 of 325 (0.6%)	61 of 325 (18.8%)	Not reported
Open-label 3-DAA	5 of 324 (1.5%)	55 of 324 (17%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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.
Related Info.Link provided by the sponsor.

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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 ombitasvir/paritaprevir/ritonavir and dasabuvir in people with 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 6 inclusion and 6 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 27 Oct 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 27 Oct 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 With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of active 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 NCT02517515, 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 27 Oct 2017.