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Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia (outCome)

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ClinicalTrials.gov Identifier: NCT02851069
Recruitment Status : Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

The interferon-free combination regimen of Paritaprevir/r - Ombitasvir with or without Dasabuvir (ABBVIE REGIMEN) ± Ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Colombia in a clinical practice patient population.


Condition or disease
Chronic Hepatitis C

Study Type : Observational
Actual Enrollment : 66 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 - An Observational Study in Colombia (outCome)
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
HCV Genotype 1 participants
Participants receiving Paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV)



Primary Outcome Measures :
  1. Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12) [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug


Secondary Outcome Measures :
  1. The percentage of participants with virological response at end of treatment (EoT). [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Virological response defined as HCV RNA level less than 50 IU/mL.

  2. The number of participants meeting premature study drug discontinuation [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    Defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure

  3. The percentage of participants meeting missing SVR12 data and/or none of the above criteria [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
  4. The percentage of participants with relapse [ Time Frame: Up to EoT, maximum of 24 week ]
    Relapse defined as HCV RNA less than 50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to s50 IU/mL post-treatment

  5. The percentage of participants with relapse at EoT [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL

  6. The number of participants with co-morbidities. [ Time Frame: Day 0 ]
  7. The percentage of participants with breakthrough. [ Time Frame: Up to EoT, maximum of 24 weeks ]
    Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment

  8. The number of participants with concomitant medications. [ Time Frame: Day 0 to end of treatment, maximum week 24 ]
  9. The percentage of participants meeting on-treatment virologic failure [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL)

  10. The change in participants Quality of Life measured with the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire. [ Time Frame: Day 0 to post treatment Week 24 ]
    Five items in the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) are rated on 5 levels of severity.



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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
Participants with CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.
Criteria

Inclusion Criteria:

  • Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
  • If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
  • Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:


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): NCT02851069


Locations
Colombia
Fundacion Cardioinfantil /ID# 155724
Bogota, Colombia
Cic Cali /Id# 163986
Cali, Colombia, 760001
Centro Medico Imbanaco de Cali /ID# 163660
Cali, Colombia
Pharos Centro de Estudios Clin /ID# 161709
Cartagena, Colombia, 130013
IPS Medicos Internistas Del Ca /ID# 163987
Manizales, Colombia, 170004
Fundacion Hospitalaria San Vin /ID# 167437
Medellin, Colombia, 050010
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02851069     History of Changes
Other Study ID Numbers: P16-024
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Chronic Hepatitis C
Paritaprevir/r - Ombitasvir, ± Dasabuvir
Sustained Virological Response
Observational Study
Chronic Hepatitis C genotype 1

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, 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