Chronic Hepatitis CNCT02798315

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

An observational study of Chronic Hepatitis C, run by AbbVie.

Completed

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

Trial summary

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Chronic Hepatitis C
How many people: 40 participants
Where: No sites listed yet
Study dates: 25 May 2016to 12 Jun 2017
Phase: Observational
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

Study population: Participants with CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.

Who may be able to join

Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Who cannot join

Participant must not be participating or attending in a concurrent interventional therapeutic trial.

About this study

Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Kuwait in a clinical practice patient population.

Conditions: Chronic Hepatitis C
Keywords: Paritaprevir/r - Ombitasvir, ± Dasabuvir, Sustained Virological Response, Chronic Hepatitis C genotype 4, Observational Study, Chronic Hepatitis C genotype 1, Chronic Hepatitis C
Medical subject headings: Hepatitis C, Chronic

What participants receive

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

Study groups in NCT02798315
Study group	Role	What they receive
Participants With Hepatitis C Virus (HCV) Genotype 1 or 4		Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

What is being measured

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

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug
Measured: 12 weeks (i.e. at least 70 days) after the last dose of study drug

Secondary outcomes (10)

Percentage of Participants With Virological Response at End of Treatment (EoT)
Virological response defined as HCV RNA level less than 50 IU/mL.
Measured: Up to EoT, maximum of 24 weeks
Percentage of Participants With Relapse at EoT
Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.
Measured: Up to EoT, maximum of 24 weeks
Percentage of Participants With Breakthrough.
Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment.
Measured: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse
On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment).
Measured: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria
Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria.
Measured: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.
Measured: Up to 48 weeks
Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV
Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.
Measured: Up to 48 weeks
Adherence: Percentage of Planned Duration of RBV Taken by Participant
Measured: Up to 48 weeks
Change From Baseline in the PAM-13 Questionnaire
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health.
Measured: Up to 48 weeks
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components
Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders).
Measured: Up to EoT, maximum of 24 weeks

Timeline

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

25 May 201612 Jun 2017

First posted14 Jun 2016 (estimated)
Study start25 May 2016
Primary completion12 Jun 2017
Study completion12 Jun 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 CStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02798315
Sponsor's protocol ID: P15-699
Status last verified: Jun 2017
First submitted: 9 Jun 2016
Last updated: 31 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
PubMed 30739368

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait
ClinicalTrials.gov ID: NCT02798315
Acronym / sponsor ID: P15-699
Conditions: Chronic Hepatitis C
Keywords: Paritaprevir/r - Ombitasvir, ± Dasabuvir, Sustained Virological Response, Chronic Hepatitis C genotype 4, Observational Study, Chronic Hepatitis C genotype 1, Chronic Hepatitis C
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 25 May 2016 (actual)
Primary completion: 12 Jun 2017 (actual)
Study completion: 12 Jun 2017 (actual)
First posted: 14 Jun 2016 (estimated)
Results: Posted 31 Dec 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

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Participants With Hepatitis C Virus (HCV) Genotype 1 or 4	–	–Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.

Key inclusion criteria (3 listed)

Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Key exclusion criteria (1 listed)

Participant must not be participating or attending in a concurrent interventional therapeutic trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

10 secondary outcomes

Percentage of Participants With Virological Response at End of Treatment (EoT)
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants With Relapse at EoT
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants With Breakthrough.
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
Time frame: Up to 48 weeks
Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV
Time frame: Up to 48 weeks
Adherence: Percentage of Planned Duration of RBV Taken by Participant
Time frame: Up to 48 weeks
Change From Baseline in the PAM-13 Questionnaire
Time frame: Up to 48 weeks
Patient Support Program (PSP) Questionnaire: Utilization of PSP Components
Time frame: Up to EoT, maximum of 24 weeks

Results and safety

Results posted to the registry on 31 Dec 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
Participants With Hepatitis C Virus (HCV) Genotype 1 or 4	40	39

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

Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Participants With HCV Genotype 1 or 4 n = 39
Value	100 (91.0 to 100.0)

Population analysed: Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Nonserious adverse events (AEs): up to 48 Weeks. Serious AEs were reported to AbbVie from the time the physician obtains the participant's authorization to use and disclose information until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With HCV Genotype 1 or 4	0 of 40 (0%)	4 of 40 (10%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30739368Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Hepatitis C

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

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.

Hany Salaheldine, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C, 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 1 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 31 Dec 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 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 Virological Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks (i.e. at least 70 days) after the last 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 NCT02798315, 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 31 Dec 2018.