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Completed

NCT Number: NCT01411449

Primovist Post-marketing Surveillance in Japan

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.

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Key information

Conditions

Diagnostic Imaging

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received Primovist for liver MRI

Exclusion criteria

  • Patients who are contraindicated based on the product label

Treatment and study plan

Gadoxetic acid disodium (Primovist, BAY86-4873)

Drug

Patients who will need to undergo contrast enhanced MRI with Primovist

Primary outcomes

  1. Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist

    Time frame: After Primovist injection, up to 7 days

  2. Incidence of adverse drug reactions in patients with renal impairment

    Time frame: After Primovist injection, up to 7 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of EOB-Primovist Inj. Syringe

Acronym: PRIMOVIST

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
Aug 8, 2011
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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