Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

N/ACompletedNCT03071133

Bristol-Myers Squibb344 enrolled

Overview

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

Study Type

OBSERVATIONAL

Enrollment

344

Conditions

Hepatitis C

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of Aspartate Aminotransferase (AST) elevation

measured by immunoassay

Time frame: Up to 36 weeks

Incidence of Alanine Aminotransferase (ALT) elevation

measured by immunoassay

Time frame: Up to 36 weeks

Incidence of Total Bilirubin (tBili) elevation

measured by immunoassay

Time frame: Up to 36 weeks

Secondary Outcomes

Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan

measured by adverse events

Time frame: Up to 36 weeks

Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)

measured by number of patients

Time frame: Up to 24 weeks

Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)

measured by number of patients

Time frame: Up to 36 weeks

Percentage of patients to experience virologic breakthrough

measured by percentage of patients

Time frame: Up to 36 weeks

Data from ClinicalTrials.gov

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