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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

South-Ural State Med. Academy, Chelyabinsk, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Time frame: End of treatment, maximum of 12 weeks

Virological response is defined as HCV RNA less than 50 IU/mL.
Percentage of Participants With Relapse

Time frame: End of treatment (week 12) and up to 12 weeks after the end of treatment.

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.
Percentage of Participants With Breakthrough

Time frame: 12 weeks

Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.
Percentage of Participants With Failure to Suppress

Time frame: 12 weeks

Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Percentage of Participants With Missing SVR12 Data

Time frame: 12 weeks after the last dose of study drug (week 24)

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: CITRIN

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Feb 15, 2017
Registry last updated: Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed