Primovist Post-marketing Surveillance in Japan

Diagnostic Imaging Clinical Trial

— PRIMOVIST  

Official title:

Drug Use Investigation of EOB-Primovist Inj. Syringe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411449
• Other study ID #: 15040
• Status: Completed
• Phase: N/A
• First received: August 5, 2011
• Last updated: March 16, 2017
• Start date: March 11, 2008
• Est. completion date: February 18, 2015

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2030
• Est. completion date: February 18, 2015
• Est. primary completion date: December 14, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who received Primovist for liver MRI

Exclusion Criteria:

• Patients who are contraindicated based on the product label

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Drug:
• Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Patients who will need to undergo contrast enhanced MRI with Primovist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist		After Primovist injection, up to 7 days
Primary	Incidence of adverse drug reactions in patients with renal impairment		After Primovist injection, up to 7 days
Secondary	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
Secondary	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

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