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Primovist Post-marketing Surveillance in Japan (PRIMOVIST)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01411449
First received: August 5, 2011
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Diagnostic Imaging
 Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of EOB-Primovist Inj. Syringe

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist [ Time Frame: After Primovist injection, up to 7 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse drug reactions in patients with renal impairment [ Time Frame: After Primovist injection, up to 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2030
Study Start Date: March 2008
Study Completion Date: December 2010
Groups/Cohorts Assigned Interventions
Group 1 Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Patients who will need to undergo contrast enhanced MRI with Primovist

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411449

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01411449     History of Changes
Other Study ID Numbers: 15040
Study First Received: August 5, 2011
Last Updated: July 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Primovist
MRI agent

ClinicalTrials.gov processed this record on May 23, 2013