Diagnostic Imaging Clinical Trial
— PRIMOVISTOfficial title:
Drug Use Investigation of EOB-Primovist Inj. Syringe
Verified date | March 2017 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 2030 |
Est. completion date | February 18, 2015 |
Est. primary completion date | December 14, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients who received Primovist for liver MRI Exclusion Criteria: - Patients who are contraindicated based on the product label |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist | After Primovist injection, up to 7 days | ||
Primary | Incidence of adverse drug reactions in patients with renal impairment | After Primovist injection, up to 7 days | ||
Secondary | Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist] | After Primovist injection, up to 7 days | ||
Secondary | 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 | After Primovist injection, up to 7 days |
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