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OpenTrials
Completed

NCT Number: NCT05428397

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Wuppertal, 42096, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iopromide (Ultravist, BAY86-4877)

Diagnostic Test

X-Ray/CT Diagnostic Imaging

Other names: BAY86-4877_Iopromide_IV_X-Ray/CT Diagnostic Agents

Primary outcomes

  1. Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different sex

    Time frame: ≤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.

  2. Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients with different race

    Time frame: ≤1 hour after contrast administration

  3. Hypersensitivity reaction (HSR) to Ultravist (iopromide) in patients from different countries/regions

    Time frame: ≤1 hour after contrast administration

Secondary outcomes

  1. Differences regarding specific HSRs in patients with different sex

    Time frame: ≤1 hour after contrast administration

  2. Differences regarding specific HSRs in patients with different race

    Time frame: ≤1 hour after contrast administration

  3. Differences regarding specific HSRs in patients from different countries/regions

    Time frame: ≤1 hour after contrast administration

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Safety Profile of Ultravist in Patients With Different Sexes, Races and From Different Countries/Regions

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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