EMR200098_008: 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)

Study identification

• EU PAS number:
  EUPAS16520
• Study ID:
  24336
• Official title and acronym:
  EMR200098_008: 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:
  Discontinued

Research institutions and networks

Institutions

Parc Taulí Hospital University Barcelona

Study timelines

Date when funding contract was signed

Actual:06/04/2009

Study start date

Actual:04/01/2011

Date of final study report

Planned:30/09/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

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)

Other study registration identification numbers and links

EMR 200098_008Saizen® Long Term Observational study