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NCT03344458 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
A Phase 3 study, sponsored by Ascendis Pharma A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 298
- Enrollment target
NCT03344458: Completed Phase 3 study, sponsored by Ascendis Pharma A/S.
NCT03344458 is a Phase 3 study that has completed, run by Ascendis Pharma A/S. The registered enrollment target is 298 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03344458, a Phase 3 study, has completed, sponsored by Ascendis Pharma A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 298 participants
- Enrollment target
Study 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.
Primary Outcome
Long-term safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
Interventions
- DRUG TransCon hGH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 3 |
What the finished NCT03344458 record still lists
NCT03344458 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which TransCon hGH is the first listed.
NCT03344458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03344458 about?
NCT03344458 is a clinical study titled "A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial". 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 wi...
What is the current status of trial NCT03344458?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 298 participants. The study started on 2017-12-19. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT03344458?
The interventions under investigation include: TransCon hGH (DRUG).
Who is sponsoring clinical trial NCT03344458?
This trial is sponsored by Ascendis Pharma A/S, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03344458's enrollment target sits among peer trials
298 1162nd of 2000 higher than 838 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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