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

NCT ID: NCT02727933

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1941 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-03

Study Completion Date

2020-07-05

Brief Summary

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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

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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Other Identifiers

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AI444-335

Identifier Type: -

Identifier Source: org_study_id

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