LiverNCT00924248
Primovist Regulatory Post Marketing Surveillance (PMS)
An observational study of Liver, run by Bayer at 1 site in South Korea.
Trial summary
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver
- What is being tested?
- Gadoxetic acid disodium (Primovist, BAY86-4873)
- How many people
- 4,358 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to May 2011
- 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: Korean who take Primovist for liver MRI
Who may be able to join
- Patient who take Primovist for liver MRI
Who cannot join
- Patients who belong to the contraindication on the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primovist Regulatory Post Marketing Surveillance
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
- Conditions
- Liver
- Being tested
- Gadoxetic acid disodium (Primovist, BAY86-4873)
- Keywords
- Liver MRI
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 in daily life clinical practice treatment receiving Primovist according to indication on the label.
| 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.
Safety evaluation in real practice (SAE/AE/ADR collection)
Measured: After administration
Secondary outcomes (3)
Assessment of contrast effect by imaging after administration
Measured: Before administration
Overall contrast effects by combining individual assessment
Measured: Before administration
Assessment of contrast enhancement effect
Measured: After administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startOct 2007
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiverStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924248
- Sponsor's protocol ID
- 14332
- Other IDs
- PR0810KR
- Status last verified
- Sep 2012
- First submitted
- 17 Jun 2009
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primovist Regulatory Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT00924248
- Acronym / sponsor ID
- 14332
- Conditions
- Liver
- Keywords
- Liver MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,358 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Study completion
- May 2011 (actual)
- First posted
- 18 Jun 2009 (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.
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice
Study design
- Observational model
- Cohort
- 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
- Korean who take Primovist for liver MRI
Key inclusion criteria (1 listed)
- Patient who take Primovist for liver MRI
Key exclusion criteria (1 listed)
- Patients who belong to the contraindication 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 in daily life clinical practice treatment receiving Primovist according to indication on the label. | Drug | Group 1 |
Primary outcome
Safety evaluation in real practice (SAE/AE/ADR collection)
Time frame: After administration
3 secondary outcomes
Assessment of contrast effect by imaging after administration
Time frame: Before administration
Overall contrast effects by combining individual assessment
Time frame: Before administration
Assessment of contrast enhancement effect
Time frame: After administration
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 19 Sep 2012.
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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 Liver, run by Bayer at 1 site in South Korea.
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 19 Sep 2012. 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 South Korea. 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?
Safety evaluation in real practice (SAE/AE/ADR collection) (time frame: After administration). 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 19 Sep 2012.