HCVPhase 3NCT02247401

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

A Phase 3 study testing 2 DAA and RBV in people with HCV and Hepatitis C Infection, run by AbbVie.

Completed

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

Trial summary

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: HCV, Hepatitis C Infection, Genotype 4
What is being tested?: 2 DAA and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: 4 Nov 2014to 1 Aug 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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)
Subjects must meet one of the following:
Treatment-naive: Subject has never received antiviral treatment for HCV infection OR
Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV);
Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Who cannot join

Females who are pregnant or breastfeeding
Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
abnormal laboratory tests
self-reports current drinking more than 2 drinks per day
current enrollment in another investigational study

Show all 9Show fewer

previous treatment with a direct acting antiviral agent (DAA) containing regimen
In substudy 1, evidence of liver cirrhosis
In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma

About this study

Official title: An Open-Label Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Read the detailed description

Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Conditions: HCV, Hepatitis C Infection, Genotype 4
Being tested: 2 DAA, RBV
Keywords: Genotype 4, non-responder, treatment experienced, HCV, naive, relapser, hepatitis infection, compensated cirrhosis, hepatitis c, Cirrhosis, Egypt, null responder, partial responder
Medical subject headings: Hepatitis C, Fibrosis

What participants receive

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

2 DAADrug
ABT-450/r/ABT-267 tablets
RBVDrug
Ribavirin tablets

Study groups in NCT02247401
Study group	Role	What they receive
Arm A	Active comparator	ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. Receives: Drug: 2 DAA; Drug: RBV
Arm B	Active comparator	ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. Receives: Drug: 2 DAA; Drug: RBV
Arm C	Active comparator	ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. Receives: Drug: 2 DAA; Drug: RBV

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) in Each Treatment Arm
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.
Measured: 12 weeks after last dose
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Measured: Screening until 30 days after last dose

Secondary outcomes (2)

Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.
Measured: Up to 12 or 24 weeks after first dose
Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
Post-treatment relapse was defined as defined as confirmed HCV RNA > LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Measured: Up to 12 weeks after first dose

Timeline

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

4 Nov 20141 Aug 2016

First posted25 Sep 2014 (estimated)
Study start4 Nov 2014
Primary completion1 Aug 2016
Study completion1 Aug 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 HCVStudies 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: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02247401
Sponsor's protocol ID: M14-250
Status last verified: Jul 2021
First submitted: 19 Sep 2014
Last updated: 30 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16.
PubMed 28404110

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 Study to Evaluate the Safety and Efficacy of the Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Chronic Hepatitis C Virus Genotype 4 Infection in Egypt
ClinicalTrials.gov ID: NCT02247401
Acronym / sponsor ID: M14-250
Conditions: HCV, Hepatitis C Infection, Genotype 4
Keywords: Genotype 4, non-responder, treatment experienced, HCV, naive, relapser, hepatitis infection, compensated cirrhosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 4 Nov 2014
Primary completion: 1 Aug 2016 (actual)
Study completion: 1 Aug 2016 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 27 Jul 2017

Clinical summary

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

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Detailed description

Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm A	Active comparator	Drug: 2 DAA, Drug: RBVABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent [DAA]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis.
Arm B	Active comparator	Drug: 2 DAA, Drug: RBVABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.
Arm C	Active comparator	Drug: 2 DAA, Drug: RBVABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)
Subjects must meet one of the following:
Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan
In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Key exclusion criteria (9 listed)

Females who are pregnant or breastfeeding
Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype
abnormal laboratory tests
self-reports current drinking more than 2 drinks per day

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
2 DAAABT-450/r/ABT-267 tablets	Drug	Arm A, Arm B, Arm C
RBVRibavirin tablets	Drug	Arm A, Arm B, Arm C

Primary outcome

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
Time frame: 12 weeks after last dose
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.
Number of Participants With Adverse Events
Time frame: Screening until 30 days after last dose
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

2 secondary outcomes

Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm
Time frame: Up to 12 or 24 weeks after first dose
Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm
Time frame: Up to 12 weeks after first dose

Results and safety

Results posted to the registry on 27 Jul 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
Arm A	100	94
Arm B	31	29
Arm C	29	27

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

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

Measure	Arm A n = 100	Arm B n = 31	Arm C n = 29
Value	94.0 (87.5 to 97.2)	96.8 (83.8 to 99.4)	93.1 (78.0 to 98.1)

Population analysed: Intent-to-treat population: all participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With Adverse Events

Time frame: Screening until 30 days after last dose. Count of participants. Unit: Participants

Measure	Arm A n = 100	Arm B n = 31	Arm C n = 29
Value	80	26	25

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 adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	2 of 100 (2%)	79 of 100 (79%)	Not reported
Arm B	0 of 31 (0%)	24 of 31 (77.4%)	Not reported
Arm C	2 of 29 (6.9%)	25 of 29 (86.2%)	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 28404110Waked I, Shiha G, Qaqish RB, Esmat G, Yosry A, Hassany M, Soliman R, Mohey MA, Allam N, Zayed N, Asselah T, Hall C, Redman R, Mobashery N, Doss W. Ombitasvir, paritaprevir, and ritonavir plus ribavirin for chronic hepatitis C virus genotype 4 infection in Egyptian patients with or without compensated cirrhosis (AGATE-II): a multicentre, phase 3, partly randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):36-44. doi: 10.1016/S2468-1253(16)30002-4. Epub 2016 Jun 16.

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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.

Sarah Kopecky-Bromberg, PhD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2 DAA and RBV in people with HCV and Hepatitis C Infection, 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 9 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 27 Jul 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) in Each Treatment Arm (time frame: 12 weeks after last dose). 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 NCT02247401, 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.