Primovist Post-marketing Surveillance in Japan

NCT ID: NCT01411449

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2030 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-11
• Study Completion Date: 2015-02-18

Brief Summary

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.

Conditions

Diagnostic Imaging

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Intervention Type: DRUG

Patients who will need to undergo contrast enhanced MRI with Primovist

Interventions

Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Patients who will need to undergo contrast enhanced MRI with Primovist

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who received Primovist for liver MRI

Exclusion Criteria

• Patients who are contraindicated based on the product label

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , Japan

Countries

Japan

Other Identifiers

15040

Identifier Type: -

Identifier Source: org_study_id