Chronic Hepatitis CHCV RWENCT02669940

Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation

An observational study of Chronic Hepatitis C and Genotype 1, 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 seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Chronic Hepatitis C, Genotype 1
How many people: 158 participants
Where: No sites listed yet
Study dates: 15 Apr 2016to 4 Jul 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: Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Who may be able to join

Patients are eligible for observation in this cohort if the following applies:
Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, 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 informed consent prior to inclusion into the study

Who cannot join

Patient must not be participating or intending to participate 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 in the Russian Federation - An Observational, Multi-Center Study

Conditions: Chronic Hepatitis C, Genotype 1
Keywords: Ombitasvir, Dasabuvir, Paritaprevir
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 NCT02669940
Study group	Role	What they receive
Participants With Chronic Hepatitis C Genotype 1		Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± 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 paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (8)

Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
Measured: 12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough
Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
Measured: 12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress
Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Measured: 12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse
Relapse is 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 posttreatment.
Measured: 12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Measured: 12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
Measured: 12 weeks after last actual dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Measured: 24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment
Virologic response is defined as HCV RNA < 50 IU/mL.
Measured: From baseline until end of treatment (12 or 24 weeks after actual first dose)

Timeline

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

15 Apr 20164 Jul 2017

First posted1 Feb 2016 (estimated)
Study start15 Apr 2016
Primary completion4 Jul 2017
Study completion4 Jul 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.
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: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02669940
Sponsor's protocol ID: P15-743
Acronym: HCV RWE
Status last verified: Jul 2018
First submitted: 28 Jan 2016
Last updated: 14 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 14 Nov 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 in the Russian Federation - An Observational, Multi-Center Study
ClinicalTrials.gov ID: NCT02669940
Acronym / sponsor ID: HCV RWE / P15-743
Conditions: Chronic Hepatitis C, Genotype 1
Keywords: Ombitasvir, Dasabuvir, Paritaprevir
Study type: Observational
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 15 Apr 2016 (actual)
Primary completion: 4 Jul 2017 (actual)
Study completion: 4 Jul 2017 (actual)
First posted: 1 Feb 2016 (estimated)
Results: Posted 14 Nov 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 Chronic Hepatitis C Genotype 1	–	–Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± 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: Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Key inclusion criteria (4 listed)

Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, 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 informed consent prior to inclusion into the study

Key exclusion criteria (1 listed)

Patient must not be participating or intending to participate 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 after the last actual 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 paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

8 secondary outcomes

Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Time frame: 12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Breakthrough
Time frame: 12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Failure to Suppress
Time frame: 12 weeks after the last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Relapse
Time frame: 12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
Time frame: 12 weeks after last actual dose of study drug
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
Time frame: 12 weeks after last actual dose of study drug
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
Time frame: 24 weeks after last actual dose of study drug
Percentage of Participants Achieving Virological Response at End of Treatment
Time frame: From baseline until end of treatment (12 or 24 weeks after actual first dose)

Results and safety

Results posted to the registry on 14 Nov 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
Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV	63	62
Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV	95	92

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

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

Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n = 63	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n = 93	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n = 156
Core Population	22.2 (12.7 to 34.5)	16.1 (9.3 to 25.2)	18.6 (12.8 to 25.6)
Core Population Subgroup	23.3 (13.4 to 36.0)	17.0 (9.9 to 26.6)	19.6 (13.5 to 26.9)

Population analysed: Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for \>55 days (for 12-week treatment) or \>139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: The observational period for participants receiving 12 weeks of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV was maximum 36 weeks (12 weeks treatment and 24 weeks posttreatment observation). For participants receiving 24 weeks of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV the observational period was maximum 48 weeks (24 weeks treatment and 24 weeks posttreatment observation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	2 of 63 (3.2%)	14 of 63 (22.2%)	0 of 63
Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	0 of 93 (0%)	16 of 95 (16.8%)	0 of 95
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV	2 of 156 (1.3%)	30 of 158 (19%)	0 of 158

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Andrey Strugovschikov, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C and Genotype 1, 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 14 Nov 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 14 Nov 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 after the last actual 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 NCT02669940.

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 14 Nov 2018.