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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: |
NCT02582671 |
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Date of registration:
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20/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
REACH |
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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 Ireland |
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Date of first enrolment:
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November 5, 2015 |
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Target sample size:
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101 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02582671 |
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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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Ireland
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Contacts
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Name:
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AbbVie Inc. |
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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
chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the
interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in
line with the current local label
- If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line
with the current local label (with special attention to contraception requirements and
contraindication during pregnancy)
- Participants had to voluntarily sign and date an informed consent form prior to
inclusion into the study
- Participants must not have participated or intended to participate in a concurrent
interventional therapeutic trial
Exclusion Criteria:
- None
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C
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Intervention(s)
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Drug: Ribavirin
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Drug: Dasabuvir
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Drug: Ombitasvir/paritaprevir/ritonavir
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Primary Outcome(s)
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Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
[Time Frame: 12 weeks after the last actual dose of study drug]
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Secondary Outcome(s)
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Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
[Time Frame: 12 weeks after the last actual dose of study drug]
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Percentage of Participants Meeting Relapse Criteria
[Time Frame: Up to 12 weeks after the last actual dose of study drug]
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Percentage of Participants With On-treatment Virologic Failure
[Time Frame: Up to 24 weeks]
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Percentage of Participants With Relapse
[Time Frame: From the end of treatment through the end of study (maximum of 48 weeks post-treatment)]
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Percentage of Participants With Viral Breakthrough
[Time Frame: Up to 24 weeks]
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Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
[Time Frame: Up to 24 weeks]
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Percentage of Participants With Virologic Response at End of Treatment (EOT)
[Time Frame: Up to 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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