Skip to main content
OpenTrials
Completed

NCT Number: NCT02669940

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genotype 1 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)

    Time frame: 12 weeks after the last actual dose of study drug

    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.

Secondary outcomes

  1. Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse

    Time frame: 12 weeks after last actual dose of study drug

    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.

  2. SVR12 Non-Response: Percentage of Participants With Breakthrough

    Time frame: 12 weeks after the last actual dose of study drug

    Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.

  3. SVR12 Non-Response: Percentage of Participants With Failure to Suppress

    Time frame: 12 weeks after the last actual dose of study drug

    Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.

  4. SVR12 Non-Response: Percentage of Participants With Relapse

    Time frame: 12 weeks after last actual dose of study drug

    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.

  5. SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure

    Time frame: 12 weeks after last actual dose of study drug

    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.

  6. SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data

    Time frame: 12 weeks after last actual dose of study drug

  7. Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)

    Time frame: 24 weeks after last actual dose of study drug

    SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

  8. Percentage of Participants Achieving Virological Response at End of Treatment

    Time frame: From baseline until end of treatment (12 or 24 weeks after actual first dose)

    Virologic response is defined as HCV RNA < 50 IU/mL.

Other outcomes

  1. Percentage of Participants Achieving SVR12: Additional Analysis

    Time frame: 12 weeks after the last actual dose of study drug

    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.

  2. Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis

    Time frame: 12 weeks after last actual dose of study drug

    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.

  3. SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis

    Time frame: 12 weeks after the last actual dose of study drug

    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.

  4. SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis

    Time frame: 12 weeks after the last actual dose of study drug

    Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.

  5. SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis

    Time frame: 12 weeks after last actual dose of study drug

    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.

  6. Percentage of Participants Achieving SVR24: Additional Analysis

    Time frame: 24 weeks after last actual dose of study drug

    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.

  7. Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis

    Time frame: From baseline until end of treatment (12 or 24 weeks after actual first dose)

    Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Acronym: HCV RWE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2016
Registry last updated
Nov 14, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.