Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation

Chronic Hepatitis C Clinical Trial

— HCV RWE  

Official title:

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669940
• Other study ID #: P15-743
• Status: Completed
• Start date: April 15, 2016
• Est. completion date: July 4, 2017

Study information

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

Clinical Trial Summary

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 4, 2017
• Est. primary completion date: July 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Patients are eligible for observation in this cohort if the following applies:

• Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label

• If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

• Patients must voluntarily sign and date informed consent prior to inclusion into the study

Exclusion Criteria:

• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Genotype 1
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Achieving SVR12: Additional Analysis	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	12 weeks after the last actual dose of study drug
Other	Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA =50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value = 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ? 50 IU/mL or positive posttreatment.	12 weeks after last actual dose of study drug
Other	SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA =50 IU/mL or positive during treatment.	12 weeks after the last actual dose of study drug
Other	SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis	Failure to suppress is defined as each measured on-treatment HCV RNA value = 50 IU/mL or positive.	12 weeks after the last actual dose of study drug
Other	SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis	Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ? 50 IU/mL or positive posttreatment.	12 weeks after last actual dose of study drug
Other	Percentage of Participants Achieving SVR24: Additional Analysis	SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	24 weeks after last actual dose of study drug
Other	Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis	Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.	From baseline until end of treatment (12 or 24 weeks after actual first dose)
Primary	Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA =50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value = 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ? 50 IU/mL posttreatment.	12 weeks after last actual dose of study drug
Secondary	SVR12 Non-Response: Percentage of Participants With Breakthrough	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA =50 IU/mL during treatment.	12 weeks after the last actual dose of study drug
Secondary	SVR12 Non-Response: Percentage of Participants With Failure to Suppress	Failure to suppress is defined as each measured on-treatment HCV RNA value = 50 IU/mL.	12 weeks after the last actual dose of study drug
Secondary	SVR12 Non-Response: Percentage of Participants With Relapse	Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ? 50 IU/mL posttreatment.	12 weeks after last actual dose of study drug
Secondary	SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure	On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA = 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value = 50 IU/mL or positive.	12 weeks after last actual dose of study drug
Secondary	SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data		12 weeks after last actual dose of study drug
Secondary	Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)	SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.	24 weeks after last actual dose of study drug
Secondary	Percentage of Participants Achieving Virological Response at End of Treatment	Virologic response is defined as HCV RNA < 50 IU/mL.	From baseline until end of treatment (12 or 24 weeks after actual first dose)

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