Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)

August 27, 2021 updated by: Bristol-Myers Squibb

Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C

Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

3

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

  • China
    • Beijing
      • Beijing, Beijing, China, 100054
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Local Institution

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients who receive branded DCV-based therapy in the real-world treatment setting for the first time under the approved indications.

Description

Inclusion Criteria:

  • Participants 18 years of age and older
  • Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label

Exclusion Criteria:

  • Participants under the age of 18

Other protocol defined inclusion/exclusion criteria could apply

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

Cohorts and Interventions

Group / Cohort
HCV participant population in China

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events (AEs)
Time Frame: Approximately 72 weeks
Approximately 72 weeks
Number of serious adverse events (SAEs)
Time Frame: Approximately 72 weeks
Approximately 72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who discontinue therapy due to an AE
Time Frame: Approximately 72 weeks
Approximately 72 weeks
Effectiveness of daclatasvir DCV-based therapy
Time Frame: Approximately 72 weeks
As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ)
Approximately 72 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)

May 8, 2018

Primary Completion (ACTUAL)

March 29, 2019

Study Completion (ACTUAL)

March 29, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-396

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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