Diagnostic ImagingPRIMOVISTNCT01411449
Primovist Post-marketing Surveillance in Japan
An observational study of Diagnostic Imaging, run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- Gadoxetic Acid Disodium (Primovist, BAY86-4873)
- How many people
- 2,030 participants
- Where
- 1 siteJapan
- Study dates
- 11 Mar 2008to 18 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who received Primovist for liver MRI
Who cannot join
- Patients who are contraindicated based on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of EOB-Primovist Inj. Syringe
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.
- Conditions
- Diagnostic Imaging
- Being tested
- Gadoxetic Acid Disodium (Primovist, BAY86-4873)
- Keywords
- Primovist, MRI agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoxetic Acid Disodium (Primovist, BAY86-4873)Drug
Patients who will need to undergo contrast enhanced MRI with Primovist
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
Measured: After Primovist injection, up to 7 days
Incidence of adverse drug reactions in patients with renal impairment
Measured: After Primovist injection, up to 7 days
Secondary outcomes (2)
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]
Measured: 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
Measured: After Primovist injection, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study start11 Mar 2008
- Primary completion14 Dec 2010
- Study completion18 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411449
- Sponsor's protocol ID
- 15040
- Acronym
- PRIMOVIST
- Status last verified
- Mar 2017
- First submitted
- 5 Aug 2011
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of EOB-Primovist Inj. Syringe
- ClinicalTrials.gov ID
- NCT01411449
- Acronym / sponsor ID
- PRIMOVIST / 15040
- Conditions
- Diagnostic Imaging
- Keywords
- Primovist, MRI agent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,030 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2008 (actual)
- Primary completion
- 14 Dec 2010 (actual)
- Study completion
- 18 Feb 2015 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who received Primovist for liver MRI
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on the product label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadoxetic Acid Disodium (Primovist, BAY86-4873)Patients who will need to undergo contrast enhanced MRI with Primovist | Drug | Group 1 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Imaging, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist (time frame: After Primovist injection, up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.