HypersensitivityNCT04605471
A Study to Learn More About the Safety of Ultravist in Children and in the Elderly
An observational study of Hypersensitivity, run by Bayer at 1 site in Germany.
Trial summary
Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Iopromide(Ultravist, BAY86-4877)
- How many people
- 132,850 participants
- Where
- 1 siteGermany
- Study dates
- 31 Oct 2020to 31 Mar 2021
- 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 study population consists of patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons
Who may be able to join
- We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.
Who cannot join
- Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Four company sponsored non-interventional studies with iopromide
Berlin
About this study
Official title: Safety Profile of Ultravist in Children and Elderly (UV Age)
Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety.
Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults.
Read more
The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study.
All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.
- Conditions
- Hypersensitivity
- Being tested
- Iopromide(Ultravist, BAY86-4877)
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopromide(Ultravist, BAY86-4877)Drug
The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide.
| Study group | Role | What they receive |
|---|---|---|
| PMS I study | 'PMS I' was conducted in contrast-enhanced X-ray examination between June 1999 and November 2003 in 27 countries in Europe, Africa and Asia and comprised 74,717 patients of which 2,172 were children and 32,103 were elderly patients.
Ref. Kopp AF, Mortele KJ, Cho YD, Palkowitsch P, Bettmann MA, Claussen CD. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol. 2008;49(8):902-11. Receives: Drug: Iopromide(Ultravist, BAY86-4877) | |
| IMAGE study | 'IMAGE' consists of 44,835 patients with contrast-enhanced X-ray examination and was conducted in 21 European and Asian countries from February 2008 to September 2009, 1,451 patients were children, and 15,654 were elderly patients.
Ref. Palkowitsch P, Lengsfeld P, Stauch K, Heinsohn C, Kwon ST, Zhang SX, et al. Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE). Acta Radiol. 2012;53(2):179-86. Receives: Drug: Iopromide(Ultravist, BAY86-4877) | |
| TRUST study | 'TRUST' assessed the safety and tolerability of Ultravist in patients undergoing cardiac catheterization. It was conducted from August 2010 to September 2011 in China and included 17,513 patients of which 12 were children and 8,918 were elderly patients.
Ref. Chen JY, Liu Y, Zhou YL, Tan N, Zhang B, Chen PY, et al. Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial. Int J Cardiovasc Imaging. 2015;31(7):1281-91. Receives: Drug: Iopromide(Ultravist, BAY86-4877) | |
| Ultravist in CT study | 'Ultravist in CT' was performed with focus on contrast-enhanced CT examination between November 2006 and December 2008 and included 15,168 patients in Germany, Iran, Romania and Saudi Arabia. A total of 417 patients were children, 7,453 were elderly patients.
Ref. Palkowitsch PK, Bostelmann S, Lengsfeld P. Safety and tolerability of iopromide intravascular use: a pooled analysis of three non-interventional studies in 132,012 patients. Acta Radiol. 2014;55(6):707-14. Receives: Drug: Iopromide(Ultravist, BAY86-4877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults
Measured: Analysis will be done in 2 months
Secondary outcomes (2)
Profile of HSRs (hypersensitivity reactions) in the three age groups
Measured: Analysis will be done in 2 months
General reported ADR (adverse drug reactions) profile in the three age groups
Measured: Analysis will be done in 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start31 Oct 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypersensitivityStudies 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
- Retrospective
- Enrolment
- 132,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605471
- Sponsor's protocol ID
- 21494
- Status last verified
- Jul 2021
- First submitted
- 22 Oct 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Endrikat J, Chernova J, Gerlinger C, Pracz M, Lengsfeld P, Bhatti A, Michel A. Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering >288 Million Administrations. Invest Radiol. 2022 May 1;57(5):318-326. doi: 10.1097/RLI.0000000000000840.
PubMed 34860739
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of Ultravist in Children and Elderly (UV Age)
- ClinicalTrials.gov ID
- NCT04605471
- Acronym / sponsor ID
- 21494
- Conditions
- Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132,850 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 28 Oct 2020 (actual)
- 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.
Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety.
Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults.
The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study.
All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PMS I study | – | Drug: Iopromide(Ultravist, BAY86-4877)'PMS I' was conducted in contrast-enhanced X-ray examination between June 1999 and November 2003 in 27 countries in Europe, Africa and Asia and comprised 74,717 patients of which 2,172 were children and 32,103 were elderly patients. Ref. Kopp AF, Mortele KJ, Cho YD, Palkowitsch P, Bettmann MA, Claussen CD. Prevalence of acute reactions to iopromide: postmarketing surveillance study of 74,717 patients. Acta Radiol. 2008;49(8):902-11. |
| IMAGE study | – | Drug: Iopromide(Ultravist, BAY86-4877)'IMAGE' consists of 44,835 patients with contrast-enhanced X-ray examination and was conducted in 21 European and Asian countries from February 2008 to September 2009, 1,451 patients were children, and 15,654 were elderly patients. Ref. Palkowitsch P, Lengsfeld P, Stauch K, Heinsohn C, Kwon ST, Zhang SX, et al. Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE). Acta Radiol. 2012;53(2):179-86. |
| TRUST study | – | Drug: Iopromide(Ultravist, BAY86-4877)'TRUST' assessed the safety and tolerability of Ultravist in patients undergoing cardiac catheterization. It was conducted from August 2010 to September 2011 in China and included 17,513 patients of which 12 were children and 8,918 were elderly patients. Ref. Chen JY, Liu Y, Zhou YL, Tan N, Zhang B, Chen PY, et al. Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial. Int J Cardiovasc Imaging. 2015;31(7):1281-91. |
| Ultravist in CT study | – | Drug: Iopromide(Ultravist, BAY86-4877)'Ultravist in CT' was performed with focus on contrast-enhanced CT examination between November 2006 and December 2008 and included 15,168 patients in Germany, Iran, Romania and Saudi Arabia. A total of 417 patients were children, 7,453 were elderly patients. Ref. Palkowitsch PK, Bostelmann S, Lengsfeld P. Safety and tolerability of iopromide intravascular use: a pooled analysis of three non-interventional studies in 132,012 patients. Acta Radiol. 2014;55(6):707-14. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons
Key inclusion criteria (1 listed)
- We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.
Key exclusion criteria (1 listed)
- Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.
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 |
|---|---|---|
| Iopromide(Ultravist, BAY86-4877)The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide. | Drug | IMAGE study, PMS I study, TRUST study, Ultravist in CT study |
Primary outcome
Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults
Time frame: Analysis will be done in 2 months
2 secondary outcomes
Profile of HSRs (hypersensitivity reactions) in the three age groups
Time frame: Analysis will be done in 2 months
General reported ADR (adverse drug reactions) profile in the three age groups
Time frame: Analysis will be done in 2 months
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 20 Jul 2021.
- Derived from this study: PubMed 34860739Endrikat J, Chernova J, Gerlinger C, Pracz M, Lengsfeld P, Bhatti A, Michel A. Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering >288 Million Administrations. Invest Radiol. 2022 May 1;57(5):318-326. doi: 10.1097/RLI.0000000000000840.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypersensitivity, run by Bayer at 1 site in Germany.
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 20 Jul 2021. 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 Germany. 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?
Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults (time frame: Analysis will be done in 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04605471, which also lists 1 linked publication.
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 20 Jul 2021.