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Completed

NCT Number: NCT04605471

A Study to Learn More About the Safety of Ultravist in Children and in the Elderly

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.

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Key information

Conditions

Hypersensitivity Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Four company sponsored non-interventional studies with iopromide

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.

Exclusion criteria

  • Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.

Treatment and study plan

Iopromide(Ultravist, BAY86-4877)

Drug

The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide.

Primary outcomes

  1. 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

Secondary outcomes

  1. Profile of HSRs (hypersensitivity reactions) in the three age groups

    Time frame: Analysis will be done in 2 months

  2. General reported ADR (adverse drug reactions) profile in the three age groups

    Time frame: Analysis will be done in 2 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Safety Profile of Ultravist in Children and Elderly (UV Age)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Jul 20, 2021

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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