Study identification

PURI

https://redirect.ema.europa.eu/resource/48636

EU PAS number

EUPAS48635

Study ID

48636

Official title and acronym

Study on the use of non-specific immunoglobulins in patients treated at Vall d'Hebron University Hospital, Bellvitge Hospital and Germans Trias i Pujol Hospital, collected in the CatSalut's patient and treatment registry (RPT). (VDH-IGG-2021-03)

DARWIN EU® study

No

Study countries

Spain

Study description

A retrospective, multicenter, observational drug study (EOM) of diseases treated with nonspecific immunoglobulins in the clinical services of the Vall d'Hebron (HUVH), Bellvitge (HUB) and Germans Trias i Pujol (HUGTiP) hospitals. The main objectives are to describe the use of non-specific immunoglobulins in the aforementioned hospitals and to evaluate in which indications they are being administered from the RPT and to validate the indications for use of non-specific immunoglobulins from the RPT of HUVH, HUB and HGTiP.

Study status

Ongoing
Research institutions and networks

Institutions

Hospital Germans Trias i Pujol. Barcelona

Contact details

Judit Riera Arnau

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Independent study with no funding
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable