15VR8 is an open-label, long-term safety study of somavaratan in adults with growth hormone deficiency (GHD). It is open to adult patients with GHD completing the Versartis Phase 2 trial (VITAL) as well as new adult patients with GHD.
15VR8 is currently enrolling adult patients with GHD in the United States and Australia.
- 15VR8 is an open-label study and will evaluate the safety of long-term twice-monthly administration of somavaratan in adults with growth hormone deficiency (GHD).
Primary Outcome Measures:
- Safety (adverse events, concomitant medications, safety labs, vital signs, physical exams)
Secondary Outcome Measures:
- Immunogenicity of somavaratan (measurement and characterization of serum anti-drug antibody (ADA) titers)
- Pharmacodynamics of somavaratan (measurement of serum IGF-I and IGFBP-3)
- Evaluation of the starting dose and dose titration plan of twice-monthly somavaratan during the titration phase of treatment
- Evaluation of the maintenance dose and dose titration plan of twice-monthly somavaratan during long-term treatment
For more details visit: www.clinicaltrials.gov/ct2/show/NCT02719990