SAizen® Long Term Observational study (SALTO)
Research type
Research Study
Full title
Prospective, single-cohort, multicentre observational long term study in short children born small for gestational age (SGA) after treatment with Saizen®
IRAS ID
201971
Contact name
Verghese Matthew
Contact email
Sponsor organisation
Merck Serono Ltd
Duration of Study in the UK
14 years, 0 months, 1 days
Research summary
The SALTO study is a post authorization commitment (PAC) study that Merck KGaA has agreed to run with the EU Health Authorities. It has been approved by the Italian Medicines Agency.
This study is a prospective, single-cohort, multicentre, multinational observational long-term post-approval commitment study in subjects born Short for Gestational Age (SGA), with no specific age restrictions, who received Saizen® for the treatment of short stature.
The primary objective of the study is to assess the long term safety of Saizen® for 10 years after cessation of treatment, in terms of occurrence of type 2 diabetes mellitus and malignancies, in a minimum of 200 subjects born SGA who received Saizen® for the treatment of short stature. Approximately 300 subjects will be enrolled at study initiation in order to compensate for loss to follow-up.
All subjects must sign the Informed Consent Form to be enrolled in the study. Subjects may sign the ICF on the day after treatment discontinuation and up to 5 years after treatment cessation.
In the particular case where the subject is minor, the Investigator will explain the study to his/her parents or his/her legal guardian as well and will collect their written informed consents. When minors reach the legal age, patient written informed consent will be obtained again.
Because SALTO is a post-treatment observational study, no scheduled study specific visits, assessments or interventions are scheduled during the study.
Clinical data will be collected by the Investigator on an ongoing basis and when available during the course of this study through the subject’s treating physician/General Practitioner or when provided directly by the subject/person of contact. Additionally, the investigator will contact the subjects at roughly 5 and 10 years after Saizen® discontinuation in order to obtain any additional available relevant medical information.REC name
London - Surrey Research Ethics Committee
REC reference
16/LO/1105
Date of REC Opinion
8 Jul 2016
REC opinion
Further Information Favourable Opinion