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fliGHt: TransCon hGH in Children With GHD
NCT03305016Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2017
- Primary completion
- Mar 2019
- Countries
- 4
- Sponsor
- Ascendis Pharma
- Modality
- Recombinant Proteins and Enzymes, Prodrugs/Conditional Activator Small Molecules
- Drugs
- lonapegsomatropin
- Conditions
- growth hormone deficiency (GHD)
01
Overview
Phase 3, open-label, single-arm trial of lonapegsomatropin in growth hormone deficiency (GHD), sponsored by Ascendis Pharma. Primary endpoint: Number of Participants With Treatment-Emergent Adverse Events at 26 weeks. Started Nov 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
TransCon hGH
Once weekly subcutaneous injection of TransCon hGH
03
Who it enrols
Children aged 6 months to 17 years with growth hormone deficiency, either treatment-naive or previously treated with daily hGH, with open epiphyses and no history of malignancy or poorly controlled diabetes.
04
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events
Secondary
Annualized Height Velocity
Number of Subjects With IGF-1 Standard Deviation Score in the Range of 0.0 to +2.0
Change in Height Standard Deviation Scores
Number of Participants With Treatment Emergent Anti-hGH Binding Antibody Formation
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