J14VR5 Trial

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J14VR5 Trial

J14VR5 is a randomized, Phase 2/3, open-label, multi-center study of the pharmacokinetics (PK), pharmacodynamics (PD), safety and efficacy of a long-acting human growth hormone, somavaratan, in pre-pubertal Japanese children with growth hormone deficiency (GHD).

The J14VR5 trial is currently enrolling Phase 3 patients and is being conducted in Japan.

Purpose

  • The completed Phase 2 stage of the J14VR5 trial determined that PK profiles and PD responses in Japanese GHD children were comparable to the PK/PD observed in U.S. GHD children in the Phase 1b/2a study (protocol 12VR2).
  • The Phase 3 stage has been initiated at a dose of 3.5 mg/kg, twice-monthly, and will continue dosing for 12 months to obtain safety and efficacy data on 48 total subjects.

Primary Outcome Measures:

  • Efficacy (annual height velocity)
  • Safety

Key Secondary Outcome Measures:

  • Pharmacodynamics (IGF-I and IGFBP-3 responses to study drug administration)

For more details visit: www.clinicaltrials.gov/ct2/show/NCT02413138