WUH: A phase 3 long term open-label trial investigating safety and efficacy of Transcon hGH administered once weekly in children with growth hormone deficiency (GHD) who have completed a prior Transcon hGH trial.

Brief description of study

This is a multicenter, phase 3, long-term, open-label extension trial of weekly TransCon hGH in children with Growth Hormone Deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. All subjects completing a prior phase 3 TransCon hGH trial who have not permanently discontinued trial medication, are without evidence of closed epiphyses, and meet all other entry criteria will be invited to participate. The final visit of the prior trial should serve as the first visit (Visit 1) of the extension trial and data collected in the prior trial will serve as baseline data for the extension trial. After Visit 1, subsequent visits will occur 5 days (±1 day) post-dose at Week 13 (±2 weeks) and then every 13 weeks (±2 weeks) ongoing. Following informed consent, subjects will enter the extension trial and begin or continue TransCon hGH (depending on prior trial medication). Initially, TransCon hGH will be provided in single-use glass vials and administered with syringe and needle. Once available, TransCon hGH will be supplied in dual-chamber cartridges for administration using a TransCon hGH auto-injector in select countries.


Clinical Study Identifier: s18-01436
ClinicalTrials.gov Identifier: NCT03344458
Principal Investigator: Paul Saenger
Currently Recruiting

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