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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071133
• Other study ID #: AI443-144
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Locations

Country	Name	City	State
Japan	Local Institution	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Aspartate Aminotransferase (AST) elevation	measured by immunoassay	Up to 36 weeks
Primary	Incidence of Alanine Aminotransferase (ALT) elevation	measured by immunoassay	Up to 36 weeks
Primary	Incidence of Total Bilirubin (tBili) elevation	measured by immunoassay	Up to 36 weeks
Secondary	Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan	measured by adverse events	Up to 36 weeks
Secondary	Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)	measured by number of patients	Up to 24 weeks
Secondary	Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)	measured by number of patients	Up to 36 weeks
Secondary	Percentage of patients to experience virologic breakthrough	measured by percentage of patients	Up to 36 weeks

External Links

•   BMS Clinical Trial Information
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