Chronic Hepatitis C InfectionPhase 2NCT01672983

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

A Phase 2 study testing ABT-450/ritonavir, ABT-267 in people with Chronic Hepatitis C Infection, 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

This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Hepatitis C Infection
What is being tested?: ABT-450/ritonavir, ABT-267
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: No sites listed yet
Study dates: Jul 2012to May 2014
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).

Who cannot join

Significant liver disease with any cause other than HCV as the primary cause
Positive screen for drugs or alcohol.
Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
Use of contraindicated medications within 2 weeks of dosing
Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.

About this study

Official title: A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

Read the detailed description

This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b- infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks. The Post-treatment Phase evaluated the evolution and persistence of viral resistance to ABT-267 and ABT-450.

Conditions: Chronic Hepatitis C Infection
Being tested: ABT-450/ritonavir, ABT-267
Keywords: Japanese, Hepatitis C, Genotype 2, Genotype 1b, paritaprevir, ombitasvir, ritonavir, VIEKIRAX Combination Tablets
Medical subject headings: Hepatitis C

What participants receive

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

ABT-450/ritonavir, ABT-267Drug
Also called ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, ritonavir also known as Norvir, ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)

Study groups in NCT01672983
Study group	Role	What they receive
Arm 1	Experimental	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. Receives: Drug: ABT-450/ritonavir, ABT-267
Arm 2	Experimental	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. Receives: Drug: ABT-450/ritonavir, ABT-267
Arm 3	Experimental	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks. Receives: Drug: ABT-450/ritonavir, ABT-267
Arm 4	Experimental	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks. Receives: Drug: ABT-450/ritonavir, ABT-267
Arm 5	Experimental	Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. Receives: Drug: ABT-450/ritonavir, ABT-267
Arm 6	Experimental	Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks. Receives: Drug: ABT-450/ritonavir, ABT-267

What is being measured

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

Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
Measured: 24 weeks after last dose of study drug
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.
Measured: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.

Secondary outcomes (2)

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)
The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
Measured: 12 weeks after last dose of study drug
Percentage of Participants With End of Treatment (EOT) Response
The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.
Measured: 12 or 24 weeks after first 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.

Jul 2012May 2014

First posted27 Aug 2012 (estimated)
Study startJul 2012
Primary completionMay 2014
Study completionMay 2014

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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis C InfectionStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01672983
Sponsor's protocol ID: M12-536
Status last verified: Oct 2015
First submitted: 27 Jul 2012
Last updated: 30 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015 May;61(5):1523-32. doi: 10.1002/hep.27705. Epub 2015 Mar 23.
PubMed 25644279
Schnell G, Tripathi R, Krishnan P, Beyer J, Reisch T, Irvin M, Dekhtyar T, Setze C, Rodrigues L Jr, Alves K, Burroughs M, Redman R, Chayama K, Kumada H, Collins C, Pilot-Matias T. Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir. J Med Virol. 2018 Jan;90(1):109-119. doi: 10.1002/jmv.24923. Epub 2017 Sep 22.
PubMed 28842997

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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All Chronic Hepatitis C Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT01672983
Acronym / sponsor ID: M12-536
Conditions: Chronic Hepatitis C Infection
Keywords: Japanese, Hepatitis C, Genotype 2, Genotype 1b, paritaprevir, ombitasvir, ritonavir, VIEKIRAX Combination Tablets
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 27 Aug 2012 (estimated)
Results: Posted 26 Nov 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Arm 1	Experimental	Drug: ABT-450/ritonavir, ABT-267Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Arm 2	Experimental	Drug: ABT-450/ritonavir, ABT-267Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Arm 3	Experimental	Drug: ABT-450/ritonavir, ABT-267Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
Arm 4	Experimental	Drug: ABT-450/ritonavir, ABT-267Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
Arm 5	Experimental	Drug: ABT-450/ritonavir, ABT-267Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Arm 6	Experimental	Drug: ABT-450/ritonavir, ABT-267Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).

Key exclusion criteria (5 listed)

Significant liver disease with any cause other than HCV as the primary cause
Positive screen for drugs or alcohol.
Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
Use of contraindicated medications within 2 weeks of dosing
Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.

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/ritonavir, ABT-267Also: ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, ritonavir also known as Norvir, ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination TabletsABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)	Drug	Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6

Primary outcome

Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
Time frame: 24 weeks after last dose of study drug
The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
Number of Participants With Adverse Events (AEs)
Time frame: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.

2 secondary outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With End of Treatment (EOT) Response
Time frame: 12 or 24 weeks after first dose of study drug

Results and safety

Results posted to the registry on 26 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	18	18
Arm 2	18	18
Arm 3	19	19
Arm 4	18	18
Arm 5	19	19
Arm 6	18	18

Primary outcome: Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)

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

Measure	Arm 1 n = 18	Arm 2 n = 18	Arm 3 n = 19	Arm 4 n = 18	Arm 5 n = 19	Arm 6 n = 18
Value	100 (81.47 to 100.00)	88.9 (65.29 to 98.62)	100 (82.35 to 100.00)	100 (81.47 to 100.00)	57.9 (33.50 to 79.75)	72.2 (46.52 to 90.31)

Population analysed: Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.. Number. Unit: participants

Measure	Arm 1 + Arm 5 n = 37	Arm 2 + Arm 6 n = 36	Arm 3 n = 19	Arm 4 n = 18
Adverse Events	28	31	16	15
Serious Adverse Events	1	2	2	0

Population analysed: Safety population: all participants who received at least 1 dose of study drug

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 18 (0%)	14 of 18 (77.8%)	Not reported
Arm 2	2 of 18 (11.1%)	15 of 18 (83.3%)	Not reported
Arm 3	2 of 19 (10.5%)	16 of 19 (84.2%)	Not reported
Arm 4	0 of 18 (0%)	15 of 18 (83.3%)	Not reported
Arm 5	1 of 19 (5.3%)	14 of 19 (73.7%)	Not reported
Arm 6	0 of 18 (0%)	16 of 18 (88.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25644279Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015 May;61(5):1523-32. doi: 10.1002/hep.27705. Epub 2015 Mar 23.
Derived from this study: PubMed 28842997Schnell G, Tripathi R, Krishnan P, Beyer J, Reisch T, Irvin M, Dekhtyar T, Setze C, Rodrigues L Jr, Alves K, Burroughs M, Redman R, Chayama K, Kumada H, Collins C, Pilot-Matias T. Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir. J Med Virol. 2018 Jan;90(1):109-119. doi: 10.1002/jmv.24923. Epub 2017 Sep 22.
Related InfoLink 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.

Takuma Matsuda, MS study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-450/ritonavir, ABT-267 in people with Chronic Hepatitis C Infection, 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 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 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Nov 2015). 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 24 Weeks After Treatment (SVR24) (time frame: 24 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 NCT01672983, which also lists 2 linked publications.

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 May 2018.