Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
Completed
- Conditions
- Hepatitis C
- Registration Number
- NCT03071133
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
Inclusion Criteria
- Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration
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Exclusion Criteria
- Patients who use the DCV Trio off label
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Alanine Aminotransferase (ALT) elevation Up to 36 weeks measured by immunoassay
Incidence of Aspartate Aminotransferase (AST) elevation Up to 36 weeks measured by immunoassay
Incidence of Total Bilirubin (tBili) elevation Up to 36 weeks measured by immunoassay
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan Up to 36 weeks measured by adverse events
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) Up to 24 weeks measured by number of patients
Percentage of patients to experience virologic breakthrough Up to 36 weeks measured by percentage of patients
Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24) Up to 36 weeks measured by number of patients
Trial Locations
- Locations (1)
Local Institution
🇯🇵Tokyo, Japan