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

Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03071133

Enrollment

344

Registered

2017-03-06

Start date

2018-01-01

Completion date

2019-01-08

Last updated

2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Aspartate Aminotransferase (AST) elevation	Up to 36 weeks	measured by immunoassay
Incidence of Alanine Aminotransferase (ALT) elevation	Up to 36 weeks	measured by immunoassay
Incidence of Total Bilirubin (tBili) elevation	Up to 36 weeks	measured by immunoassay

Secondary

Measure	Time frame	Description
Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan	Up to 36 weeks	measured by adverse events
Percentage of patients to experience virologic breakthrough	Up to 36 weeks	measured by percentage of patients
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)	Up to 24 weeks	measured by number of patients
Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)	Up to 36 weeks	measured by number of patients

Countries

Japan

Outcome results