Long-acting FC-fusion rhGH (GX-H9) shows potential for up to twice-monthly administration in GH-deficient adults - Aix-Marseille Université Accéder directement au contenu
Article Dans Une Revue European Journal of Endocrinology Année : 2018

Long-acting FC-fusion rhGH (GX-H9) shows potential for up to twice-monthly administration in GH-deficient adults

Cheol Ryong Ku
  • Fonction : Auteur
Katharina Schilbach
  • Fonction : Auteur
Stanislav Ignatenko
  • Fonction : Auteur
Sandor Magony
  • Fonction : Auteur
Yoon-Sok Chung
  • Fonction : Auteur
Byung-Joon Kim
  • Fonction : Auteur
Kyu Yeon Hur
  • Fonction : Auteur
Ho-Cheol Kang
  • Fonction : Auteur
Jung Hee Kim
  • Fonction : Auteur
Min Seon Ki
  • Fonction : Auteur
Aldona Kowalska
  • Fonction : Auteur
Marek Bolanowski
  • Fonction : Auteur
Marek Ruchala
  • Fonction : Auteur
Svetozar Damjanovic
  • Fonction : Auteur
Juraj Payer
  • Fonction : Auteur
Yun Jung Choi
  • Fonction : Auteur
Su Jin Heo
  • Fonction : Auteur
Tae Kyoung Kim
  • Fonction : Auteur
Minkyu Heo
  • Fonction : Auteur
Joan Lee
  • Fonction : Auteur
Eun Jig Lee
  • Fonction : Auteur

Résumé

Objective: Hybrid Fc-fused rhGH (GX-H9) is a long-acting recombinant human growth hormone (GH) under clinical development for both adults and children with GH deficiency (GHD). We compared the safety, pharmacokinetics and pharmacodynamics of weekly and every other week (EOW) dosages of GX-H9 with those of daily GH administration in adult GHD (AGHD) patients. Design: This was a randomized, open-label, active-controlled and dose-escalation study conducted in 16 endocrinology centers in Europe and Korea. Methods: Forty-five AGHD patients with or without prior GH treatment were enrolled. Patients with prior GH treatments were required to have received the last GH administration at least 1 month prior to randomization. Subjects were sequentially assigned to treatment groups. Fifteen subjects were enrolled to each treatment group and randomly assigned to receive either GX-H9 or Genotropin (4:1 ratio). GX-H9 dosage regimens for Groups 1, 2 and 3 were 0.1 mg/kg weekly, 0.3 mg/kg EOW and 0.2 mg/kg EOW, respectively. All Genotropin-assigned subjects received 6 mu g/kg Genotropin, regardless of treatment group. Main outcome analyses included measurements of serum insulin-like growth factor 1 (IGF-I), safety, pharmacokinetics, pharmacodynamics and immunogenicity. Results: Mean GX-H9 peak and total exposure increased with an increase in dose after a single-dose administration. The mean IGF-I response was sustained above baseline over the intended dose interval of 168 h for the weekly and 336 h for the EOW GX-H9 groups. Safety profiles and immunogenicity were not different across the treatment groups and with Genotropin. Conclusions: GX-H9 has the potential for up to twice-monthly administration.
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Dates et versions

hal-01991346 , version 1 (23-01-2019)

Identifiants

  • HAL Id : hal-01991346 , version 1

Citer

Cheol Ryong Ku, Thierry Brue, Katharina Schilbach, Stanislav Ignatenko, Sandor Magony, et al.. Long-acting FC-fusion rhGH (GX-H9) shows potential for up to twice-monthly administration in GH-deficient adults. European Journal of Endocrinology, 2018, 179 (3), pp.169-179. ⟨hal-01991346⟩

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