A Study, Called UV Population, to Learn More About the Safety of the Study Drug Ultravist, Which is Given to Get Clearer X-ray Pictures, in People of Different Sexes, Races, and From Different Countries/Regions

Completed

• Conditions: Contrast Enhanced X-ray Based Examination
• Interventions: Diagnostic Test: Iopromide (Ultravist, BAY86-4877)

• Registration Number: NCT05428397
• Lead Sponsor: Bayer

Brief Summary

This is an observational study in which patient data from the past of people who received Ultravist prior to an X-ray based scan are studied.

In observational studies, only observations are made without specified advice or interventions.

X-ray based imaging like computed tomography or angiography is used to make pictures of the structures inside the body. These pictures are needed in various medical situations. In some X-ray tests, the patient is given a compound called "contrast agent" that is injected into the vein. It helps to create clearer pictures as it makes internal body structures easier to see. With such contrast-enhanced imaging techniques, doctors can better see certain problems.

Ultravist is an iodine-based contrast agent. It is also called iopromide, and it is available for doctors to give patients before they have X-ray based scans.

Clinical studies on the overall safety of Ultravist have shown that hypersensitivity reactions (HSRs) may rarely occur. HSRs are undesirable reactions of the body's defense system (immune system) to the study drug. However, more information on HSRs is needed.

The main aim of this study is to find out whether certain groups of people are more likely to have HSRs after Ultravist injection than others (e.g., depending on gender, race, or country/region).

To do this, researchers will collect data from people with HSRs (all ages) after contrast-enhanced X-ray scans with Ultravist. These data come from four observational studies that have already been completed. Participants who had HSRs will be compared with participants in these studies who had no medical problems after receiving Ultravist to learn more about the characteristics of people at higher risk.

Data will be from the year 1999 up to 2011. No visits or tests are required as part of this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-06-30
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152233

Inclusion Criteria

• Patients of all age groups which were referred to any iodine-based contrast-enhanced procedure after administration of either Ultravist 300 mg I/mL or 370 mg I/mL.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Contrast enhanced X-ray based examination with Ultravist	Iopromide (Ultravist, BAY86-4877)	Patients who received a contrast enhanced X-ray based examination with Ultravist for various clinical reasons and having experienced a hypersensitivity reaction.
Control group	Iopromide (Ultravist, BAY86-4877)	Patient who received contrast enhanced X-ray based examination with Ultravist for various indications who had not adverse event.

Primary Outcome Measures

Name	Time	Method
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex	≤1 hour after contrast administration	Cases (based on MedDRA version 21.0): Patients with any typical and unequivocal hypersensitivity reaction: anaphylactoid shock, angioedema, asthma, bronchospasm, conjunctivitis, cough, dysphagia, dyspnea, edema mucosal, erythema/exanthema/rash, hoarseness, lacrimation, laryngeal/pharyngeal/face edema, laryngeal/pharyngeal spasm, nasal stuffiness, pruritus/itching, respiratory arrest, rhinitis, sneezing, stridor, swelling (eyes/face), throat irritation, tongue edema, urticaria/hives/blisters, wheezing.
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race	≤1 hour after contrast administration
Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions	≤1 hour after contrast administration

Secondary Outcome Measures

Name	Time	Method
Differences regarding specific HSRs in patients with different race	≤1 hour after contrast administration
Differences regarding specific HSRs in patients with different sex	≤1 hour after contrast administration
Differences regarding specific HSRs in patients from different countries/regions	≤1 hour after contrast administration

Trial Locations

Locations (1)

Bayer; 🇩🇪 Wuppertal, Germany