Clinical trial NCT03053180: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: Paritaprevir
Dasabuvir
Ombitasvir
Ritonavir
Ribavirin free
Chronic Hepatitis C genotype 1b (GT1b)
Cirrhosis
Compensated liver cirrhosis
Hepatitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last dose of study drug (week 24)
Secondary outcomes:
measure: Percentage of Participants Achieving Virological Response at End of Treatment (EoT)
timeFrame: End of treatment, maximum of 12 weeks
measure: Percentage of Participants With Relapse
timeFrame: End of treatment (week 12) and up to 12 weeks after the end of treatment.
measure: Percentage of Participants With Breakthrough
timeFrame: 12 weeks
measure: Percentage of Participants With Failure to Suppress
timeFrame: 12 weeks
measure: Percentage of Participants With Missing SVR12 Data
timeFrame: 12 weeks after the last dose of study drug (week 24)
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: South-Ural State Med. Academy
city: Kirov
country: Russian Federation
facility: KOGBUZ Kirovsk Infect Hosp
city: Krasnodar
country: Russian Federation
facility: Specialized Clinical Infectiou
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Hos
city: Samara
country: Russian Federation
facility: LLC Medical Company
city: Saratov
country: Russian Federation
facility: GBOU VPO Saratov state Med Uni
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clin Hosp
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: