Chronic Hepatitis CoutComeNCT02851069

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia

An observational study of Chronic Hepatitis C, run by AbbVie at 6 sites in Colombia.

Completed

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

Trial summary

This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C
How many people: 66 participants
Where: 6 sitesColombia
Study dates: 23 Feb 2017to 30 Aug 2018
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with chronic hepatitis C (CHC), genotype 1, 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, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± 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).
Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Who cannot join

None

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Colombia6 sites

Fundacion Cardioinfantil
Bogotá
Cic Cali
Cali, 760001
Centro Medico lmbanaco de Cali I
Cali
Pharos Centro de Estudios Clin
Cartagena, 130013
IPS Medicos Internistas Del Ca I
Manizales, 170004
Fundacion Hospitalaria San Vin
Medellín, 050010

Other trials in Colombia

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 Colombia (outCome)

This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.

Read the detailed description

This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.

After written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.

This study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:

12-week treatment regimen: four visits plus two interim data collection windows
24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC.

Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C, Paritaprevir/r - Ombitasvir, ± Dasabuvir, Sustained Virological Response, Observational Study, Chronic Hepatitis C genotype 1
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 NCT02851069
Study group	Role	What they receive
Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)		ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] with or without dasabuvir [250 mg twice daily]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.

What is being measured

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

Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]).
Measured: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)

Secondary outcomes (9)

Percentage of Participants With Virologic Response at End of Treatment (EoT)
Virologic response is defined as HCV RNA level <50 IU/mL.
Measured: Up to EoT, maximum of 24 weeks
Number of Participants Meeting Premature Study Drug Discontinuation
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]).
Measured: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria
For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:
- 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] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]);
- Relapse (defined as HCV RNA <50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment [not more than 7 days shortened]);
- Premature study drug discontinuation with no on-treatment virologic failure;
- Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).
Abbreviations: EoT=end of treatment.
Measured: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
Percentage of Participants With Relapse
Relapse was defined as confirmed 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 in participants who were treated.
Measured: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Relapse at EoT
Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.
Measured: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Measured: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting On-treatment Virologic Failure
On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).
Measured: Up to EoT, maximum of 24 weeks
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)
RVR4 was defined as HCV RNA < 50 IU/mL at Week 4.
Measured: Week 4
Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT
SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.
Measured: 24 weeks after EoT (up to 24 weeks)

Timeline

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

23 Feb 201730 Aug 2018

First posted1 Aug 2016 (estimated)
Study start23 Feb 2017
Primary completion30 Aug 2018
Study completion30 Aug 2018

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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02851069
Sponsor's protocol ID: P16-024
Acronym: outCome
Status last verified: May 2019
First submitted: 28 Jul 2016
Last updated: 18 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: 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?

See locations

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 18 Sep 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 Colombia (outCome)
ClinicalTrials.gov ID: NCT02851069
Acronym / sponsor ID: outCome / P16-024
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C, Paritaprevir/r - Ombitasvir, ± Dasabuvir, Sustained Virological Response, Observational Study, Chronic Hepatitis C genotype 1
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 23 Feb 2017 (actual)
Primary completion: 30 Aug 2018 (actual)
Study completion: 30 Aug 2018 (actual)
First posted: 1 Aug 2016 (estimated)
Results: Posted 18 Sep 2019

Clinical summary

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

Detailed description

12-week treatment regimen: four visits plus two interim data collection windows
24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC.

Study design

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

Arm	Type	Receives
Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)	–	–ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] with or without dasabuvir [250 mg twice daily]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with chronic hepatitis C (CHC), genotype 1, 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, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± 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).
Participant 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 Virologic Response at 12 Weeks (SVR12) Post-treatment
Time frame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)
SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]).

9 secondary outcomes

Percentage of Participants With Virologic Response at End of Treatment (EoT)
Time frame: Up to EoT, maximum of 24 weeks
Number of Participants Meeting Premature Study Drug Discontinuation
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria
Time frame: During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)
Percentage of Participants With Relapse
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Relapse at EoT
Time frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug
Percentage of Participants With Viral Breakthrough
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants Meeting On-treatment Virologic Failure
Time frame: Up to EoT, maximum of 24 weeks
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)
Time frame: Week 4
Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT
Time frame: 24 weeks after EoT (up to 24 weeks)

Results and safety

Results posted to the registry on 18 Sep 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)	65	59

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

Time frame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	ABBVIE REGIMEN ± Ribavirin (RBV) n = 65
Value	87.7 (77.5 to 93.6)

Population analysed: Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABBVIE REGIMEN	5 of 49 (10.2%)	5 of 49 (10.2%)	0 of 49
ABBVIE REGIMEN Plus Ribavirin (RBV)	2 of 16 (12.5%)	9 of 16 (56.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
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".
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Active, not recruitingPhase 4
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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.

AbbVie Inc. study director

AbbVie

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C, run by AbbVie at 6 sites in Colombia.

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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 18 Sep 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 Virologic Response at 12 Weeks (SVR12) Post-treatment (time frame: 12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)). 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 NCT02851069, 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 18 Sep 2019.