Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Hepatitis C Clinical Trial

Official title:

Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727933
• Other study ID #: AI444-335
• Status: Completed
• Start date: November 3, 2015
• Est. completion date: July 5, 2020

Study information

• Verified date: December 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1941
• Est. completion date: July 5, 2020
• Est. primary completion date: July 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients

• Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

Exclusion Criteria:

• Off-label use of Daklinza and Sunvepra

• Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information

Related Conditions & MeSH terms

• Hepatitis C

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities		6 months to 5 years
Secondary	Incidence proportion of AEs leading to discontinuation of study therapy		6 months to 5 years
Secondary	Incidence rate of AEs leading to discontinuation of study therapy		6 months to 5 years
Secondary	Timing of laboratory abnormalities by toxicity grade		6 months to 5 years
Secondary	Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected		4 Weeks to 24 Weeks
Secondary	The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)		24 Weeks to 36 Weeks

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls