Primovist Post-marketing Surveillance in Japan

Completed

• Conditions: Diagnostic Imaging
• Interventions: Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)

• Registration Number: NCT01411449
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-11
• Primary Completion: 2010-12-14
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Study Completion: 2015-02-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2030

Inclusion Criteria

• Patients who received Primovist for liver MRI

Exclusion Criteria

• Patients who are contraindicated based on the product label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Gadoxetic Acid Disodium (Primovist, BAY86-4873)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]	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	After Primovist injection, up to 7 days