Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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 (HCV RWE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669940
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease
Chronic Hepatitis C Genotype 1

Layout table for study information
Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : July 4, 2017
Actual Study Completion Date : July 4, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Participants With Chronic Hepatitis C Genotype 1
Participants 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669940


Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: Andrey Strugovschikov, MD AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Statistical Analysis Plan  [PDF] February 2, 2018
Study Protocol  [PDF] June 26, 2015


Additional Information:
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02669940    
Other Study ID Numbers: P15-743
First Posted: February 1, 2016    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: July 2018
Keywords provided by AbbVie:
Ombitasvir
Dasabuvir
Paritaprevir
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents