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Multi-centre phase IV trial to investigate the immunogenicity of a new liquid formulation of recombinant human growth hormone in adults with growth hormone deficiency

Artikel i vetenskaplig tidskrift
Författare Gudmundur Johannsson
K. Nespithal
U. Plockinger
V. Alam
M. McLean
Publicerad i Journal of Endocrinological Investigation
Volym 41
Nummer/häfte 8
Sidor 919-927
ISSN 1720-8386
Publiceringsår 2018
Publicerad vid Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition
Sidor 919-927
Språk en
Länkar dx.doi.org/10.1007/s40618-017-0818-...
Ämnesord Recombinant human growth hormone, Binding antibodies, Neutralising antibodies, Liquid, gh replacement therapy, body-composition, adherence, children, hgh, Endocrinology & Metabolism, kano k, 1989, acta endocrinologica, v120, p559
Ämneskategorier Endokrinologi

Sammanfattning

To investigate whether a new liquid formulation of recombinant human growth hormone (r-hGH) induces the production of binding antibodies (BAbs) in adults with congenital or adult-onset growth hormone deficiency (GHD). Men or women aged 19-65 years with adult growth hormone deficiency who were r-hGH-na < ve or had stopped treatment 1 month before screening were treated with between 0.15 and 0.30 mg/day r-hGH liquid formulation for 39 weeks. The primary endpoint was the proportion of patients who developed BAbs at any time. Secondary endpoints were the proportion of patients with BAbs who became positive for neutralising antibodies, the effects on biomarkers of r-hGH exposure, safety, and adherence to treatment downloaded from the easypod (TM) connect software. Seventy-eight patients (61.5% men) with mean age 44.5 years (range 21-65) started and 68 (87.2%) completed the 39-week treatment period. 82.1% were treatment na < ve; all were negative for BAbs to r-hGH at baseline. The median (interquartile range) duration of treatment [273 (267.0-277.0) days] was consistent with patients receiving the required doses, and mean treatment adherence measured using easypod (TM) connect was 89.3%. The proportion of patients who developed BAbs was 0% (95% confidence interval 0-4.68%) and biomarker profiles were consistent with exposure to r-hGH. 92.3% of patients reported 1 adverse event during treatment. Most events were mild or moderate and no new safety concerns were detected. The low immunogenicity profile of the liquid formulation was consistent with that for the freeze-dried formulation, and no new safety concerns were reported.

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