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)

AbbVie7 sites in 1 country60 target enrollmentMarch 20, 2017

ConditionsChronic Hepatitis C

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Hepatitis C
Sponsor: AbbVie
Enrollment: 60
Locations: 7
Primary Endpoint: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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 (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.

Registry

clinicaltrials.gov

Start Date

March 20, 2017

End Date

December 18, 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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