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

January 6, 2022 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1941

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence proportion of AEs leading to discontinuation of study therapy
Time Frame: 6 months to 5 years
6 months to 5 years
Incidence rate of AEs leading to discontinuation of study therapy
Time Frame: 6 months to 5 years
6 months to 5 years
Timing of laboratory abnormalities by toxicity grade
Time Frame: 6 months to 5 years
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
Time Frame: 4 Weeks to 24 Weeks
4 Weeks to 24 Weeks
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)
Time Frame: 24 Weeks to 36 Weeks
24 Weeks to 36 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2015

Primary Completion (Actual)

July 5, 2020

Study Completion (Actual)

July 5, 2020

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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