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Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, +/- Dasabuvir, +/- Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium

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ClinicalTrials.gov Identifier: NCT02581163
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
IST GmbH, Germany
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study is to provide evidence of the effectiveness as well as the influence of adherence on treatment outcome of Paritaprevir/ritonavir, Ombitasvir, +/- Dasabuvir, (the ABBVIE REGIMEN) ± Ribavirin (RBV) in a real world setting of hepatitis C virus infected clinical practice populations across Belgium. The study may also help identify predictive factors of response that are important in real world treatment settings. In addition, it will provide data on the impact of adherence on treatment outcomes in everyday settings, which may help treating physicians to improve the management of participants under their care.

Condition or disease
Chronic Hepatitis C, Genotype 1 or 4

Study Type : Observational
Actual Enrollment : 309 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, +/- Dasabuvir, +/- Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
Actual Study Start Date : October 7, 2015
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
GT 1 or 4 treatment-naïve or -experienced CHC participants
Treatment-naïve or -experienced participants with confirmed CHC, genotype (GT) 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



Primary Outcome Measures :
  1. Percentage of participants achieving sustained virological response at week 12 (SVR12) [ Time Frame: 12 weeks after the last dose of study drug ]
    SVR12 is defined as hepatitis c virus ribonucleic acid levels <50 IU/mL 12 weeks after the last dose of study drug.


Secondary Outcome Measures :
  1. Percentage of patients meeting Premature study drug discontinuation with no on-treatment virologic failure [ Time Frame: 12 weeks after last dose of study drug ]
  2. Percentage of patients missing SVR12 data and/or none of the criteria below: -on-treatment virologic failure or failure to suppress -relapse -premature study drug discontinuation with no on-treatment virologic failure [ Time Frame: 12 weeks after last dose of study drug ]
  3. Percentage of patients meeting relapse [ Time Frame: 12 weeks after last dose of study drug ]
    Relapse : 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 post-treatment

  4. Percentage of participants who achieved breakthrough [ Time Frame: From baseline till End of treatment: 12 or 24 weeks after first dose according to treatment schedule chosen by investigator ]
    Breakthrough is defined as at least one documented HCV RNA <50 IU/ml followed by HCV RNA ≥ 50 IU/ml during treatment.

  5. Percentage of patients meeting On-treatment virologic failure [ Time Frame: 12 weeks after last dose of study drug ]
    On-treatment virologic failure : breakthrough or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]

  6. Percentage of participants with virological response. [ Time Frame: End of treatment (EoT), 12 or 24 weeks after first dose according to treatment schedule chosen by investigator. ]
    Virologic response is defined as HCV RNA <50 IU/ml.

  7. Percentage of participants who relapse [ Time Frame: At 12 and 24 weeks after last dose of study drug ]
    Relapse is defined as HCV RNA < 50 IU/ml at end of treatment followed by HCV RNA ≥ 50 IU/ml


Other Outcome Measures:
  1. Percentage of the DAA dose taken in relation to the target dose of DAA [ Time Frame: From Baseline till EoT (12 or 24 weeks after first dose according to treatment schedule chosen by investigator) ]
    Adherence : cumulative dose taken divided by target dose in percent

  2. Percentage of missed RBV treatment days in relation to the target number of RBV treatment days [ Time Frame: From Baseline till EoT (12 or 24 weeks after first dose according to treatment schedule chosen by investigator) ]
  3. Percentage of the RBV dose taken in relation to the target dose of RBV [ Time Frame: From Baseline till EoT (12 or 24 weeks after first dose according to treatment schedule chosen by investigator) ]
    Adherence : cumulative dose taken divided by target dose in percent



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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:   Probability Sample
Study Population
Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
Criteria

Inclusion Criteria:

  • Treatment-naïve or -experienced 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)
  • Participants must sign and date an informed consent

Exclusion Criteria:

  • Participant 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): NCT02581163


Locations
Belgium
CUB Hospital Erasme
Brussels, Bruxelles-Capitale, Belgium, 1070
Cliniques Universitaires Saint Luc
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6000
CHU de Liege - Domain Universi
Liège, Liege, Belgium, 4000
Algemeen Stedelijk Ziekenhuis
Aalst, Oost-Vlaanderen, Belgium, 9300
Centre Hospitalier de Wallonie Picarde
Tournai, Wallonne, Region, Belgium, 7500
ZNA Stuivenberg
Antwerp, Belgium, 2060
CHU St. Pierre
Brussels, Belgium, 1000
CHU Brugmann
Brussels, Belgium, 1020
HIS - Bracops
Brussels, Belgium, 1070
Hospital Edith Cavell
Brussels, Belgium, 1180
HIS Moliere-Longchamp
Brussels, Belgium, 1190
UZ Antwerp
Edegem, Belgium, 2650
Z.O.L - Campus St. Jan
Genk, Belgium, 3600
AZ Maria Middelares
Ghent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Clinique St Joseph
Liege, Belgium, 4000
C.H.U.de Mons Borinage
Mons, Belgium, 7000
AZ-Delta
Roeselare, Belgium, 8800
UCL Mont Godinne
Yvoir, Belgium, 5530
Sponsors and Collaborators
AbbVie
IST GmbH, Germany
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02581163     History of Changes
Other Study ID Numbers: P15-650
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 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:
Effectiveness
Influence of adherence

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors