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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: |
NCT03071133 |
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Date of registration:
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01/03/2017 |
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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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Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
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Scientific title:
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Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis |
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Date of first enrolment:
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January 1, 2018 |
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Target sample size:
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1000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03071133 |
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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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Japan
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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:
- Patients who are initiating the treatment with DCV Trio therapy under the approved
indications, dosage, and administration
Exclusion Criteria:
- Patients who use the DCV Trio off label
Age minimum:
N/A
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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Primary Outcome(s)
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Incidence of Aspartate Aminotransferase (AST) elevation
[Time Frame: Up to 36 weeks]
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Incidence of Total Bilirubin (tBili) elevation
[Time Frame: Up to 36 weeks]
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Incidence of Alanine Aminotransferase (ALT) elevation
[Time Frame: Up to 36 weeks]
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Secondary Outcome(s)
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Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
[Time Frame: Up to 24 weeks]
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Percentage of patients to experience virologic breakthrough
[Time Frame: Up to 36 weeks]
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Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan
[Time Frame: Up to 36 weeks]
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Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)
[Time Frame: Up to 36 weeks]
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Secondary ID(s)
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AI443-144
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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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