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Clinical Trials/NCT02798315
NCT02798315CompletedNot Applicable

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait

AbbVie0 sites40 target enrollmentStarted: May 25, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Primary Endpoint
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 Kuwait in a clinical practice patient population.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •Participant must not be participating or attending in a concurrent interventional therapeutic trial.

Outcomes

Primary Outcomes

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 ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

Secondary Outcomes

  • Adherence: Percentage of Planned Duration of RBV Taken by Participant(Up to 48 weeks)
  • Change From Baseline in the PAM-13 Questionnaire(Up to 48 weeks)
  • Percentage of Participants With Breakthrough.(Up to EoT, maximum of 24 weeks)
  • Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse(12 weeks (i.e. at least 70 days) after the last dose of study drug)
  • Percentage of Participants With Virological Response at End of Treatment (EoT)(Up to EoT, maximum of 24 weeks)
  • Percentage of Participants With Relapse at EoT(Up to EoT, maximum of 24 weeks)
  • Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria(12 weeks (i.e. at least 70 days) after the last dose of study drug)
  • Patient Support Program (PSP) Questionnaire: Utilization of PSP Components(Up to EoT, maximum of 24 weeks)
  • Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA(Up to 48 weeks)
  • Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV(Up to 48 weeks)

Investigators

Sponsor
AbbVie
Sponsor Class
Industry
Responsible Party
Sponsor

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