Primovist Regulatory Post Marketing Surveillance (PMS)

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

Completed

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Key information

Conditions

Liver

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient who take Primovist for liver MRI

Exclusion criteria

Patients who belong to the contraindication on the product label

Treatment and study plan

Gadoxetic acid disodium (Primovist, BAY86-4873)

Drug

Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Primary outcomes

Safety evaluation in real practice (SAE/AE/ADR collection)

Time frame: After administration

Secondary outcomes

Assessment of contrast effect by imaging after administration

Time frame: Before administration
Overall contrast effects by combining individual assessment

Time frame: Before administration
Assessment of contrast enhancement effect

Time frame: After administration

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Primovist Regulatory Post Marketing Surveillance

Important dates

Study start: 2007
Study completion: 2011
First posted: Jun 18, 2009
Registry last updated: Sep 19, 2012

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.

Published trials that share one or more normalized conditions with this study.

Completed