A trial to investigate long term efficacy and safety of lonapegsomatropin in adults with growth hormone deficiency
A trial to investigate long term efficacy and safety of lonapegsomatropin in adults with growth hormone deficiency
ClinicalTrials.gov ID: NCT05171855
Sponsor: Ascendis Pharma Endocrinology Division A/S
Information provided by: Ascendis Pharma A/S (Ascendis Pharma Endocrinology Division A/S) (Responsible Party)
Last Update Posted: 2024-06-14
Brief Summary:
This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).
Official Title:
A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
Intervention / Treatment:
- Drug: Lonapegsomatropin
| Category | Value |
|---|---|
| Study Start (Actual) |
2021-12-16
|
| Primary Completion (Estimated) |
2024-12-01
|
| Study Completion (Estimated) |
2025-01-01
|
| Enrollment (Actual) | 233 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
TCH-306EXT
|