Study identification

PURI

https://redirect.ema.europa.eu/resource/107218

EU PAS number

EUPAS107217

Study ID

107218

Official title and acronym

An Active Surveillance Study to Monitor the Real-World Long-term Safety of Somatrogon Among Paediatric Patients in Europe

DARWIN EU® study

No

Study countries

France
Spain
Sweden
United Kingdom

Study description

The primary purpose of this study will be to assess the long-term safety of somatrogon, a long-acting hGH, under routine clinical care and is intended to reflect outcomes that occur in real-world clinical practice.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
IQVIA
United Kingdom
First published:
22/04/2024
InstitutionNon-Pharmaceutical companyENCePP partner
EPIFOCUS
Spain
United Kingdom
First published:
02/04/2025
InstitutionOtherENCePP partner

Contact details

Kofi Asomaning

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Study protocol
Initial protocol

C0311023_SOMATROGON PROTOCOL FINAL_05AUG2022.pdf

English (744.81 KB - PDF)View document
Updated protocol

C0311023_SOMATROGON_PROTOCOL_AMENDMENT_CLEAN_20MAR2023.pdf

English (472.55 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)