Chronic Hepatitis CCITRINNCT03053180

Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation

An observational study of Chronic Hepatitis C, run by AbbVie at 7 sites in Russia.

Completed

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

Trial summary

This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus… 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: 60 participants
Where: 7 sitesRussia
Study dates: 20 Mar 2017to 18 Dec 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 chronic hepatitis C (CHC) genotype 1 (GT1b) and compensated liver cirrhosis will be recruited and observed in approximately 5-7 national and regional hospitals/outpatient services in Russia.

Who may be able to join

3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial

Who cannot join

Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
Participants with Child Pugh B and C cirrhosis
Participants with a history of prior direct-acting antiviral agent (DAA) therapy
Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Russia7 sites

South-Ural State Med. Academy
Chelyabinsk, 454052
KOGBUZ Kirovsk Infect Hosp
Kirov, 610008
Specialized Clinical Infectiou
Krasnodar, 350000
Orenburg Regional Clinical Hos
Orenburg, 460018
LLC Medical Company
Samara, 443063
GBOU VPO Saratov state Med Uni
Saratov, 410012
Ulyanovsk Regional Clin Hosp
Ulyanovsk, 432018

Other trials in Russia

About this study

Official title: Real World Evidence Study of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir Without Ribavirin in Patients With Chronic HCV Gt1b Infection and Compensated Liver Cirrhosis in the RussIan FederaTion- An ObseRvational, MultI-CeNter Study (CITRIN)

Conditions: Chronic Hepatitis C
Keywords: Paritaprevir, Dasabuvir, Ombitasvir, Ritonavir, Ribavirin free, Chronic Hepatitis C genotype 1b (GT1b), Cirrhosis, Compensated liver cirrhosis, Hepatitis
Medical subject headings: Hepatitis C, Chronic, Fibrosis, Hepatitis

What participants receive

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

Study groups in NCT03053180
Study group	Role	What they receive
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir		Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a 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 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.
Measured: 12 weeks after the last dose of study drug (week 24)

Secondary outcomes (5)

Percentage of Participants Achieving Virological Response at End of Treatment (EoT)
Virological response is defined as HCV RNA less than 50 IU/mL.
Measured: End of treatment, maximum of 12 weeks
Percentage of Participants With Relapse
Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.
Measured: End of treatment (week 12) and up to 12 weeks after the end of treatment.
Percentage of Participants With Breakthrough
Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Measured: 12 weeks
Percentage of Participants With Failure to Suppress
Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Measured: 12 weeks
Percentage of Participants With Missing SVR12 Data
Measured: 12 weeks after the last dose of study drug (week 24)

Timeline

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

20 Mar 201718 Dec 2017

First posted15 Feb 2017
Study start20 Mar 2017
Primary completion18 Dec 2017
Study completion18 Dec 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03053180
Sponsor's protocol ID: P16-253
Acronym: CITRIN
Status last verified: Nov 2018
First submitted: 8 Feb 2017
Last updated: 14 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real World Evidence Study of the Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir Without Ribavirin in Patients With Chronic HCV Gt1b Infection and Compensated Liver Cirrhosis in the RussIan FederaTion- An ObseRvational, MultI-CeNter Study (CITRIN)
ClinicalTrials.gov ID: NCT03053180
Acronym / sponsor ID: CITRIN / P16-253
Conditions: Chronic Hepatitis C
Keywords: Paritaprevir, Dasabuvir, Ombitasvir, Ritonavir, Ribavirin free, Chronic Hepatitis C genotype 1b (GT1b), Cirrhosis, Compensated liver cirrhosis
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 20 Mar 2017 (actual)
Primary completion: 18 Dec 2017 (actual)
Study completion: 18 Dec 2017 (actual)
First posted: 15 Feb 2017 (actual)
Results: Posted 14 Mar 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
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir	–	–Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer a 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 chronic hepatitis C (CHC) genotype 1 (GT1b) and compensated liver cirrhosis will be recruited and observed in approximately 5-7 national and regional hospitals/outpatient services in Russia.

Key inclusion criteria (3 listed)

3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial

Key exclusion criteria (4 listed)

Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
Participants with Child Pugh B and C cirrhosis
Participants with a history of prior direct-acting antiviral agent (DAA) therapy
Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label

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 (week 24)
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

5 secondary outcomes

Percentage of Participants Achieving Virological Response at End of Treatment (EoT)
Time frame: End of treatment, maximum of 12 weeks
Percentage of Participants With Relapse
Time frame: End of treatment (week 12) and up to 12 weeks after the end of treatment.
Percentage of Participants With Breakthrough
Time frame: 12 weeks
Percentage of Participants With Failure to Suppress
Time frame: 12 weeks
Percentage of Participants With Missing SVR12 Data
Time frame: 12 weeks after the last dose of study drug (week 24)

Results and safety

Results posted to the registry on 14 Mar 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
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir	60	59

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 (week 24). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir n = 59
Value	98.3 (90.91 to 99.96)

Population analysed: Core population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of the 3DAA ABBVIE REGIMEN through 30 days after last dose (up to 16 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir	1 of 60 (1.7%)	1 of 60 (1.7%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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.

AbbVie Inc. study director

AbbVie

7 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 7 sites in Russia.

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

Where is the study taking place?

The record lists 7 sites in Russia. 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 14 Mar 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 (week 24)). 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 NCT03053180.

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 Mar 2019.