Primovist Post-marketing Surveillance in Japan (PRIMOVIST)

March 16, 2017 updated by: Bayer

Drug Use Investigation of EOB-Primovist Inj. Syringe

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2030

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

  • Japan
      • Many Locations, Japan

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

The target population of this study is patients who received Primovist for liver MRI. The study is expected to collect data of 2,000 patients in about 150 hospitals in Japan.

Description

Inclusion Criteria:

  • Patients who received Primovist for liver MRI

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Patients who will need to undergo contrast enhanced MRI with Primovist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
Time Frame: After Primovist injection, up to 7 days
After Primovist injection, up to 7 days
Incidence of adverse drug reactions in patients with renal impairment
Time Frame: After Primovist injection, up to 7 days
After Primovist injection, up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]
Time Frame: After Primovist injection, up to 7 days
After Primovist injection, up to 7 days
MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired
Time Frame: After Primovist injection, up to 7 days
After Primovist injection, up to 7 days

Collaborators and Investigators

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

Sponsor

Bayer

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 11, 2008

Primary Completion (Actual)

December 14, 2010

Study Completion (Actual)

February 18, 2015

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15040

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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