Halaven Post-Marketing Surveillance (PMS)

March 9, 2020 updated by: Eisai Korea Inc.

Post-Marketing Surveillance of Halaven Injection in Korean Patients

This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3000

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

  • Korea, Republic of
      • Busan, Korea, Republic of
      • Chuncheongnam-do, Korea, Republic of
      • Chungcheongbuk-do, Korea, Republic of
      • Chungcheongnam-do, Korea, Republic of
      • Daegu, Korea, Republic of
      • Gwangju, Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
      • Gyeongsanbuk-do, Korea, Republic of
      • Gyeongsannam-do, Korea, Republic of
      • Jeollabuk-do, Korea, Republic of
      • Jeollanam-do, Korea, Republic of
      • Seoul, Korea, Republic of

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study.

Description

Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study. This study will be conducted as complete surveillance method; participants who meet the inclusion/exclusion criteria and administrate Halaven for the first time after conclusion of agreement will be enrolled after consent.

Inclusion Criteria:

Participants who meet all of the following criteria will be eligible for inclusion in the study:

  1. Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
  2. Participants who have verbal or written consent for use of personal and medical information.

Investigators will refer to indications regarding inclusion criteria.

Exclusion Criteria:

  1. Hypersensitivity to the active substance or to any of the excipients
  2. Breast feeding
  3. Pregnancy

Investigators will refer to indications and contraindications regarding exclusion criteria.

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
Halaven
Participants who are prescribed with Halaven per approved prescribing information of Halaven.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response to Halaven treatment
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

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

Sponsor

Eisai Korea Inc.

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)

March 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKI-PMS-1201

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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