Chronic Hepatitis CREALNCT02582658

Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)

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 study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria. 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: 173 participants
Where: No sites listed yet
Study dates: 6 Oct 2015to 12 Jan 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: Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)

Who may be able to join

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (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)
Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Who cannot join

none

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 Austria (REAL)

Conditions: Chronic Hepatitis C
Keywords: Paritaprevir, Dasabuvir, Ombitasvir, Chronic Hepatitis C, HCV
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 NCT02582658
Study group	Role	What they receive
Chronic infection of HCV GT1 or GT4		Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (RBV) according to standard of care and in line with the current local label

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 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug.
Measured: 12 Weeks after the last dose of study drug

Secondary outcomes (4)

Percentage of Participants With Virological Response at End of Treatment (EoTR)
The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]).
Measured: Up to 24 weeks of treatment
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)
The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]).
Measured: Up to approximately 24 weeks
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)
SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).
Measured: 12 weeks after last dose of study drug
Percentage of Participants With Post-treatment Relapse
The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)
Measured: Up to 12 weeks after 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.

6 Oct 201512 Jan 2017

First posted21 Oct 2015 (estimated)
Study start6 Oct 2015
Primary completion12 Jan 2017
Study completion12 Jan 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: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02582658
Sponsor's protocol ID: P15-695
Acronym: REAL
Status last verified: Oct 2018
First submitted: 20 Oct 2015
Last updated: 5 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 5 Jun 2019. 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 Austria (REAL)
ClinicalTrials.gov ID: NCT02582658
Acronym / sponsor ID: REAL / P15-695
Conditions: Chronic Hepatitis C
Keywords: Paritaprevir, Dasabuvir, Ombitasvir, Chronic Hepatitis C, HCV
Study type: Observational
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 6 Oct 2015
Primary completion: 12 Jan 2017 (actual)
Study completion: 12 Jan 2017 (actual)
First posted: 21 Oct 2015 (estimated)
Results: Posted 5 Jun 2019

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
Chronic infection of HCV GT1 or GT4	–	–Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (RBV) according to standard of care and in line with the current local label

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)

Key inclusion criteria (4 listed)

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (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)
Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Key exclusion criteria (1 listed)

none

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 after the last dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug.

4 secondary outcomes

Percentage of Participants With Virological Response at End of Treatment (EoTR)
Time frame: Up to 24 weeks of treatment
Percentage of Participants With On-treatment Virologic Failure (Breakthrough)
Time frame: Up to approximately 24 weeks
Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With Post-treatment Relapse
Time frame: Up to 12 weeks after last dose of study drug

Results and safety

Results posted to the registry on 5 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABBVIE REGIMEN +/- Ribavirin (RBV)	171	146

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

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

Measure	ABBVIE REGIMEN +/- Ribavirin (RBV) n = 165
Value	84.8 (78.6 to 89.5)

Population analysed: The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.

4 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 first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABBVIE REGIMEN +/- Ribavirin (RBV)	5 of 171 (2.9%)	27 of 171 (15.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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.
Related InfoLink provided by the sponsor.

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.

Alexander P Dorr, PhD study director

AbbVie Austria

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 4 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 5 Jun 2019. 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 5 Jun 2019). 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 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 NCT02582658, 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 5 Jun 2019.