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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: |
NCT03181074 |
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Date of registration:
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07/06/2017 |
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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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Early Post-marketing Study of Daclatasvir (Daklinza) 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) in the Treatment of Chronic Hepatitis C (CHC) in Adults |
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Date of first enrolment:
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October 21, 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03181074 |
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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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Inclusion Criteria:
1. This study will include patients greater than or equal to 18 years of age with chronic
Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders,
intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver
transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir
for the treatment of chronic Hepatitis C during the specified 24-month study period.
Exclusion Criteria:
1. Subjects who received daclatasvir as part of a clinical trial.
2. Subjects who received daclatasvir for any indication other than local approved.
3. Contraindications included in the approved Mexican prescribing information.
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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Number of Adverse Events
[Time Frame: Approximately 24 months]
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Secondary Outcome(s)
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Distribution of Adverse Events by Concomitant Medication
[Time Frame: Approximately 24 months]
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Distribution of Adverse Events by Age
[Time Frame: Approximately 24 months]
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Distribution of Adverse Events by Gender
[Time Frame: Approximately 24 months]
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Distribution of Adverse Events by Interruption or Switch of Medication
[Time Frame: Approximately 24 months]
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Distribution of Adverse Events by Race
[Time Frame: Approximately 24 months]
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Secondary ID(s)
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AI444-330
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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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