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Primovist Post-marketing Surveillance in Japan (PRIMOVIST)

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ClinicalTrials.gov Identifier: NCT01411449
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diagnostic Imaging Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Study Design

Study Type : Observational
Actual Enrollment : 2030 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of EOB-Primovist Inj. Syringe
Actual Study Start Date : March 11, 2008
Primary Completion Date : December 14, 2010
Study Completion Date : February 18, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Patients who will need to undergo contrast enhanced MRI with Primovist


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients who received Primovist for liver MRI

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411449


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01411449     History of Changes
Other Study ID Numbers: 15040
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Keywords provided by Bayer:
Primovist
MRI agent