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

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

Sponsors

Lead sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief Summary

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

Overall Status Active, not recruiting
Start Date January 1, 2018
Completion Date November 14, 2019
Primary Completion Date November 14, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of Aspartate Aminotransferase (AST) elevation Up to 36 weeks
Incidence of Alanine Aminotransferase (ALT) elevation Up to 36 weeks
Incidence of Total Bilirubin (tBili) elevation Up to 36 weeks
Secondary Outcome
Measure Time Frame
Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan Up to 36 weeks
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) Up to 24 weeks
Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24) Up to 36 weeks
Percentage of patients to experience virologic breakthrough Up to 36 weeks
Enrollment 1000
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Location
facility Local Institution
Location Countries

Japan

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov