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Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT02725866
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : October 24, 2017
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 Greece in a clinical practice patient population.


Condition or disease
Chronic Hepatitis C

Study Type : Observational
Actual Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece
Study Start Date : April 5, 2016
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
HCV Genotype 1 or 4 participants
Participants receiving Paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV)



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

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

  4. 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)

  5. The percentage of participants meeting relapse [ Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug ]
    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 50 IU/mL post-treatment.

  6. 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

  7. 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 ]


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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 or 4, 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 or 4, 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): NCT02725866


Locations
Greece
General University Hospital of Alexandroupolis /ID# 149494
Alexandroupolis, Greece, 68100
General University Hospital of Alexandroupolis /ID# 153776
Alexandroupolis, Greece, 68100
Evangelismos General Hospital of Athens /ID# 151259
Athens, Greece, 10676
General Hospital of Athens, Evangelismos /ID# 149510
Athens, Greece, 10676
General Hospital of Athens "Ippokratio" /ID# 151260
Athens, Greece, 11527
General Hospital of Athens "Laiko" /ID# 149498
Athens, Greece, 11527
General and Oncology Hospital of Kifisia Agioi Anargyroi /ID# 149509
Athens, Greece, 14564
Iasso General Hospital /ID# 149503
Athens, Greece, 15562
University General Hospital of Heraklion /ID# 151436
Heraklion, Greece, 71500
University General Hospital of Ioannina /ID# 151257
Ionnina, Greece, 45500
Regional General University Hospital of Larissa /ID# 151255
Larisa, Greece, 41111
Mitera Private Hospital /ID# 149504
Marousi, Greece, P.C.15123
Regional General University Hospital of Patras /ID# 151258
Patras, Greece, 26504
Agios Panteleimon General Hospital of Nikea /ID# 149507
Pireaus, Greece, 18454
Agios Panteleimon General Hospital of Nikea /ID# 149508
Pireaus, Greece, 18454
General Hospital of Piraeus "Tzaneio" /ID# 149506
Pireaus, Greece, 18536
General Hospital of Rhodes /ID# 151256
Rhodes, Greece, 85100
Bioclinic Thessaloniki /ID# 149497
Thessaloniki, Greece, 54622
University General Hospital "AHEPA" /ID# 149505
Thessaloniki, Greece, 54636
University General Hospital "AHEPA" /ID# 153774
Thessaloniki, Greece, 54636
General Hospital of Thessaloniki Papageorgiou /ID# 149495
Thessaloniki, Greece, 56429
Interbalkan Center of Thessaloniki /ID# 149496
Thessaloniki, Greece, 57001
Sponsors and Collaborators
AbbVie
Investigators
Study Chair: Georgios Mitas, MS AbbVie Pharmaceuticals S.A. (Greece)

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02725866     History of Changes
Other Study ID Numbers: P15-842
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Observational Study
Sustained Virological Response
Chronic Hepatitis C genotype 1
Chronic Hepatitis C
Paritaprevir/r - Ombitasvir, ± Dasabuvir,
Chronic Hepatitis C genotype 4

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