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

Chronic Hepatitis C Clinical Trial

— CITRIN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053180
• Other study ID #: P16-253
• Status: Completed
• Start date: March 20, 2017
• Est. completion date: December 18, 2017

Study information

• Verified date: November 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Locations

Country	Name	City	State
Russian Federation	South-Ural State Med. Academy	Chelyabinsk
Russian Federation	KOGBUZ Kirovsk Infect Hosp	Kirov
Russian Federation	Specialized Clinical Infectiou	Krasnodar
Russian Federation	Orenburg Regional Clinical Hos	Orenburg
Russian Federation	LLC Medical Company	Samara
Russian Federation	GBOU VPO Saratov state Med Uni	Saratov
Russian Federation	Ulyanovsk Regional Clin Hosp	Ulyanovsk

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after the last dose of study drug (week 24)
Secondary	Percentage of Participants Achieving Virological Response at End of Treatment (EoT)	Virological response is defined as HCV RNA less than 50 IU/mL.	End of treatment, maximum of 12 weeks
Secondary	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.	End of treatment (week 12) and up to 12 weeks after the end of treatment.
Secondary	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.	12 weeks
Secondary	Percentage of Participants With Failure to Suppress	Failure to suppress was defined as each measured on-treatment HCV RNA value = 50 IU/mL.	12 weeks
Secondary	Percentage of Participants With Missing SVR12 Data		12 weeks after the last dose of study drug (week 24)

External Links

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