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

Completed

• Conditions: Hepatitis C

• Registration Number: NCT02727933
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-03
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Primary Completion: 2020-07-05
• Study Completion: 2020-07-05
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1941

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities	6 months to 5 years

Secondary Outcome Measures

Name	Time	Method
Timing of laboratory abnormalities by toxicity grade	6 months to 5 years
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
Incidence proportion of AEs leading to discontinuation of study therapy	6 months to 5 years
Incidence rate of AEs leading to discontinuation of study therapy	6 months to 5 years
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

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of