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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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6 June 2022 |
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Main ID: |
NCT03208322 |
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Date of registration:
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03/07/2017 |
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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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Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults
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Scientific title:
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Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults |
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Date of first enrolment:
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November 30, 2018 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03208322 |
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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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Mexico
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,
please visit www.BMSStudyConnect.com
Inclusion Criteria:
- at least 18 years of age with CHC, GT-1
- treatment-naïve and treatment-experienced (null or partial) responders
- intolerant to interferon (IFN)
- with or without cirrhosis
Exclusion Criteria:
- patients who received DCV and ASV as part of a clinical trial
- patients who received DCV and ASV for any indication other than that which is locally
approved
- contraindications included in the approved Mexican prescribing information
Other protocol defined inclusion/exclusion criteria could apply
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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Hepatitis C
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Intervention(s)
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Other: Non-Interventional
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Primary Outcome(s)
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The number of adverse events (AEs) reported by patients treated with at least one dose of daclatasvir (DCV) and at least one dose of asunaprevir (ASV) and reported to the Health Authority (HA) during a specified period.
[Time Frame: 24 months]
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Secondary Outcome(s)
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The adverse events (AEs) reported to the Health Authority (HA) during a specified period in table format identifying the report number, patient Identification number, and type of adverse event (AE).
[Time Frame: 24 months]
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Secondary ID(s)
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AI447-121
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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