An observational study in Diagnostic Imaging, sponsored by Bayer. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2017-03-17.
Sponsored by Bayer · Observational
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The target population of this study is patients who received Primovist for liver MRI. The study is expected to collect data of 2,000 patients in about 150 hospitals in Japan.
Exclusion Criteria:
Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Patients who will need to undergo contrast enhanced MRI with Primovist
Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
Time frame: After Primovist injection, up to 7 days
Incidence of adverse drug reactions in patients with renal impairment
Time frame: After Primovist injection, up to 7 days
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
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer