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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02798315 |
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Date of registration:
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09/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study
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Scientific title:
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Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Kuwait |
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Date of first enrolment:
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May 25, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02798315 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Kuwait
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Contacts
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Name:
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Hany Salaheldine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV
[Time Frame: Up to 48 weeks]
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Percentage of Participants With Virological Response at End of Treatment (EoT)
[Time Frame: Up to EoT, maximum of 24 weeks]
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Adherence: Percentage of Planned Duration of RBV Taken by Participant
[Time Frame: Up to 48 weeks]
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Percentage of Participants With Relapse at EoT
[Time Frame: Up to EoT, maximum of 24 weeks]
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Percentage of Participants With Breakthrough.
[Time Frame: Up to EoT, maximum of 24 weeks]
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Change From Baseline in the PAM-13 Questionnaire
[Time Frame: Up to 48 weeks]
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Patient Support Program (PSP) Questionnaire: Utilization of PSP Components
[Time Frame: Up to EoT, maximum of 24 weeks]
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Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse
[Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug]
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Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA
[Time Frame: Up to 48 weeks]
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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
[Time Frame: 12 weeks (i.e. at least 70 days) after the last dose of study drug]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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