Study identification

PURI

https://redirect.ema.europa.eu/resource/24336

EU PAS number

EUPAS16520

Study ID

24336

Official title and acronym

Prospective and retrospective, single-cohort, multicenter observational long-term study in short children born small for gestational age (SGA) after treatment with Saizen® or with other recombinant human growth hormone (r-hGH) products (SALTO)

DARWIN EU® study

No

Study countries

France
Germany
Spain
Sweden
United Kingdom

Study description

Prospective and retrospective, single-cohort, multicentre, multinational observational long-term follow-up study in subjects born SGA who received Saizen® or other r-hGHproducts for the treatment of short stature. The study will comprise a 10-year safety follow-up period after cessation of r-hGH treatment in short children born SGA who had received Saizen® or other r-hGH products in the frame of a sponsored clinical study or in the post-marketing setting. The subjects may be enrolled up to 5 years after treatment cessation.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Communication Center Merck KGaA

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck KGaA
Study protocol
Initial protocol

20180528_EMR200098-008_EnCepP_Final protocol_Redacted

English (7.03 MB - PDF)View document
Updated protocol

20210628_EMR200098-008_EnCepP_Final protocol_Redacted.pdf

English (1.51 MB - 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 1 (imposed as condition of marketing authorisation)