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

Completed

• Conditions: Hypersensitivity
• Interventions: Drug: Iopromide(Ultravist, BAY86-4877)

• Registration Number: NCT04605471
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Study Start: 2020-10-31
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132850

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PMS I study	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	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	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	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Profile of HSRs (hypersensitivity reactions) in the three age groups	Analysis will be done in 2 months
General reported ADR (adverse drug reactions) profile in the three age groups	Analysis will be done in 2 months

Trial Locations

Locations (1)

Four company sponsored non-interventional studies with iopromide; 🇩🇪 Berlin, Germany