CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled
Drug / intervention
TransCon hGHdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03344458
NCT03344458Phase 3Completed

enliGHten: A Multicenter, 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 Clinical Trial

Ascendis Pharma A/S·interventional·Posted Nov 17, 2017·Updated May 8, 2024

In Brief

A Phase 3 clinical trial evaluating TransCon hGH for Growth Hormone Deficiency, Pediatric and 3 related conditions. Completed, enrolled 298 participants across 42 sites in 11 countries.

Detailed Summary

A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArmenia, Australia, Belarus, Bulgaria, Georgia, Greece, New Zealand, Poland, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartDec 19, 2017
Primary CompletionFeb 21, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.6 years ago

Interventions

TransCon hGHdrug

Once weekly subcutaneous injection of TransCon hGH