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

Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605471
• Other study ID #: 21494
• Status: Completed
• Start date: October 31, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132850
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity

Intervention

Drug:
• Iopromide(Ultravist, BAY86-4877)
The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide.

Locations

Country	Name	City	State
Germany	Four company sponsored non-interventional studies with iopromide	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults		Analysis will be done in 2 months
Secondary	Profile of HSRs (hypersensitivity reactions) in the three age groups		Analysis will be done in 2 months
Secondary	General reported ADR (adverse drug reactions) profile in the three age groups		Analysis will be done in 2 months