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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 Trials | Clareo Health

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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

NCT02727933•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Local Institution

Seoul, South Korea

Key Dates

Start Date

November 3, 2015

Primary Completion Date

July 5, 2020

Completion Date

July 5, 2020

Last Updated

January 21, 2022

Enrollment

1,941

ACTUAL participants

Conditions

Hepatitis C

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HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

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HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

The National Australian HCV Point-of-Care Testing Program

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures