Risk of anaphylactoid reactions of Iopromide after intra-arterial administration (UVIA Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33695
• EU PAS number:
  EUPAS25089
• Study ID:
  33695
• Official title and acronym:
  Risk of anaphylactoid reactions of Iopromide after intra-arterial administration (UVIA Study)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 11/12/2017

Study start date

Planned: 30/09/2018

Actual: 12/10/2018

Data analysis start date

Actual: 12/10/2018

Date of final study report

Planned: 30/04/2020

Actual: 11/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

19677_Study protocol _V1.0_2018-07-19

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable