Trial Condition(s):
Diagnostic Imaging
Primovist post-marketing surveillance in Japan (PRIMOVIST)
Bayer Identifier:
15040
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
Inclusion Criteria
- Patients who received Primovist for liver MRI
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Drug use investigation of EOB-Primovist inj. Syringe
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subjects who received PrimovistTimeframe: After Primovist injection, up to 7 days
- Incidence of adverse drug reactions in patients with renal impairmentTimeframe: After Primovist injection, up to 7 days
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]Timeframe: 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) impairedTimeframe: After Primovist injection, up to 7 days
Additional Information
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