메뉴 건너뛰기




Volumn 165, Issue 3, 2011, Pages 401-409

Long-acting pegylated human GH in children with GH deficiency: A single-dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics

Author keywords

[No Author keywords available]

Indexed keywords

GROWTH HORMONE; HUMAN GROWTH HORMONE; LONG ACTING DRUG; LONG ACTING PEGYLATED HUMAN GROWTH HORMONE; NNC 126 0083; SOMATOMEDIN C; UNCLASSIFIED DRUG; DRUG DERIVATIVE; MACROGOL DERIVATIVE; NNC126 0083; NNC126-0083;

EID: 80051699844     PISSN: 08044643     EISSN: 1479683X     Source Type: Journal    
DOI: 10.1530/EJE-11-0536     Document Type: Article
Times cited : (49)

References (27)
  • 1
    • 16344387901 scopus 로고    scopus 로고
    • SM: The effect of delivery device on compliance and growth
    • Desrosiers P, O'Brien F & Blethen S. Patient outcomes in the GHMonitor: the effect of delivery device on compliance and growth. Pediatric Endocrinology Reviews 2005 2 (Supplement 3) 327-331. (Pubitemid 40469491)
    • (2005) Pediatric Endocrinology Reviews , vol.2 , Issue.SUPPL. 3 , pp. 327-331
    • Desrosiers, P.M.1    O'Brien, F.2    Blethen, S.3
  • 3
    • 45849125438 scopus 로고    scopus 로고
    • Compliance and persistence in pediatric and adult patients receiving growth hormone therapy
    • Rosenfeld RG & Bakker B. Compliance and persistence in pediatric and adult patients receiving growth hormone therapy. Endocrine Practice 2008 14 143-154.
    • (2008) Endocrine Practice , vol.14 , pp. 143-154
    • Rosenfeld, R.G.1    Bakker, B.2
  • 4
    • 0035048752 scopus 로고    scopus 로고
    • Long-term effects of continuous subcutaneous infusion versus daily subcutaneous injections of growth hormone (GH) on the insulin-like growth factor system, insulin sensitivity, body composition, and bone and lipoprotein metabolism in GH-deficient adults
    • doi:10.1210/jc.86.3.1222
    • Laursen T, Gravholt CH, Heickendorff L, Drustrup J, Kappelgaard AM, Jorgensen JO & Christiansen JS. Long-term effects of continuous subcutaneous infusion versus daily subcutaneous injections of growth hormone (GH) on the insulin-like growth factor system, insulin sensitivity, body composition, and bone and lipoprotein metabolism in GH-deficient adults. Journal of Clinical Endocrinology and Metabolism 2001 86 1222-1228. (doi:10.1210/jc.86.3.1222)
    • (2001) Journal of Clinical Endocrinology and Metabolism , vol.86 , pp. 1222-1228
    • Laursen, T.1    Gravholt, C.H.2    Heickendorff, L.3    Drustrup, J.4    Kappelgaard, A.M.5    Jorgensen, J.O.6    Christiansen, J.S.7
  • 5
    • 0027204990 scopus 로고
    • Differential regulation of serum growth hormone (GH)-binding protein during continuous infusion versus daily injection of recombinant human GH in GH-deficient children
    • doi:10.1210/jc.76.5.1135
    • Tauber M, De Bouet Du PH, Sallerin-Caute B, Rochiccioli P & Bastide R. Differential regulation of serum growth hormone (GH)-binding protein during continuous infusion versus daily injection of recombinant human GH in GH-deficient children. Journal of Clinical Endocrinology and Metabolism 1993 76 1135-1139. (doi:10.1210/jc.76.5.1135)
    • (1993) Journal of Clinical Endocrinology and Metabolism , vol.76 , pp. 1135-1139
    • Tauber, M.1    De Bouet Du, P.H.2    Sallerin-Caute, B.3    Rochiccioli, P.4    Bastide, R.5
  • 6
    • 78649237780 scopus 로고    scopus 로고
    • Multiple doses of pegylated long-acting growth hormone is well tolerated in healthy male volunteers and possesses a potential once-weekly treatment profile
    • doi:10.1111/j.1365-2265.2010.03863.x
    • Rasmussen MH, Jensen L, Anderson TW, Klitgaard T & Madsen J. Multiple doses of pegylated long-acting growth hormone is well tolerated in healthy male volunteers and possesses a potential once-weekly treatment profile. Clinical Endocrinology 2010 73 769-776. (doi:10.1111/j.1365-2265.2010.03863.x)
    • (2010) Clinical Endocrinology , vol.73 , pp. 769-776
    • Rasmussen, M.H.1    Jensen, L.2    Anderson, T.W.3    Klitgaard, T.4    Madsen, J.5
  • 7
    • 77954900288 scopus 로고    scopus 로고
    • Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile
    • doi:10.1210/jc.2009-2813
    • Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T & Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. Journal of Clinical Endocrinology and Metabolism 2010 95 3411-3417. (doi:10.1210/jc.2009-2813)
    • (2010) Journal of Clinical Endocrinology and Metabolism , vol.95 , pp. 3411-3417
    • Rasmussen, M.H.1    Bysted, B.V.2    Anderson, T.W.3    Klitgaard, T.4    Madsen, J.5
  • 10
    • 80051686319 scopus 로고    scopus 로고
    • Ethical principles for medical research involving human subjects
    • World medical association declaration of Helsinki. Adopted by the latest amendment made by the 59th WMA General Assembly, Seoul, October 2008
    • World medical association declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964; latest amendment made by the 59th WMA General Assembly, Seoul, October 2008.
    • 18th WMA General Assembly, Helsinki, Finland, June 1964
  • 11
    • 0029121073 scopus 로고
    • Serum levels of insulin-like growth factor (IGF)-binding protein-3 (IGFBP-3) in healthy infants, children, and adolescents: The relation to IGF-I, IGF-II, IGFBP-1, IGFBP-2, age, sex, body mass index, and pubertal maturation
    • doi:10.1210/jc.80.8.2534
    • Juul A, Dalgaard P, Blum WF, Bang P, Hall K, Michaelsen KF, Muller J & Skakkebaek NE. Serum levels of insulin-like growth factor (IGF)-binding protein-3 (IGFBP-3) in healthy infants, children, and adolescents: the relation to IGF-I, IGF-II, IGFBP-1, IGFBP-2, age, sex, body mass index, and pubertal maturation. Journal of Clinical Endocrinology and Metabolism 1995 80 2534-2542. (doi:10.1210/jc.80.8.2534)
    • (1995) Journal of Clinical Endocrinology and Metabolism , vol.80 , pp. 2534-2542
    • Juul, A.1    Dalgaard, P.2    Blum, W.F.3    Bang, P.4    Hall, K.5    Michaelsen, K.F.6    Muller, J.7    Skakkebaek, N.E.8
  • 12
    • 26944452043 scopus 로고    scopus 로고
    • PEGylation, successful approach to drug delivery
    • doi:10.1016/S1359-6446(05)03575-0
    • Veronese FM & Pasut G. PEGylation, successful approach to drug delivery. Drug Discovery Today 2005 10 1451-1458. (doi:10.1016/S1359-6446(05) 03575-0)
    • (2005) Drug Discovery Today , vol.10 , pp. 1451-1458
    • Veronese, F.M.1    Pasut, G.2
  • 13
    • 33845938292 scopus 로고    scopus 로고
    • PEGylated proteins: Evaluation of their safety in the absence of definitive metabolism studies
    • doi:10.1124/dmd.106.012419
    • Webster R, Didier E, Harris P, Siegel N, Stadler J, Tilbury L & Smith D. PEGylated proteins: evaluation of their safety in the absence of definitive metabolism studies. Drug Metabolism and Disposition 2007 35 9-16. (doi:10.1124/dmd.106.012419)
    • (2007) Drug Metabolism and Disposition , vol.35 , pp. 9-16
    • Webster, R.1    Didier, E.2    Harris, P.3    Siegel, N.4    Stadler, J.5    Tilbury, L.6    Smith, D.7
  • 14
    • 56749098212 scopus 로고    scopus 로고
    • Designing PEGylated therapeutic molecules: Advantages in ADMET properties
    • doi:10.1517/17460441.3.11.1293
    • Hamidi M, Rafiei P & Azadi M. Designing PEGylated therapeutic molecules: advantages in ADMET properties. Expert Opinion on Drug Discovery 2008 11 1293-1307. (doi:10.1517/17460441.3.11.1293)
    • (2008) Expert Opinion on Drug Discovery , vol.11 , pp. 1293-1307
    • Hamidi, M.1    Rafiei, P.2    Azadi, M.3
  • 16
    • 0028219557 scopus 로고
    • Low basal and persistent pulsatile growth hormone secretion are revealed in normal and hyposomatotropic men studied with a new ultrasensitive chemiluminescence assay
    • doi:10.1210/jc.78.3.526
    • Iranmanesh A, Grisso B & Veldhuis JD. Low basal and persistent pulsatile growth hormone secretion are revealed in normal and hyposomatotropic men studied with a new ultrasensitive chemiluminescence assay. Journal of Clinical Endocrinology and Metabolism 1994 78 526-535. (doi:10.1210/jc.78.3.526)
    • (1994) Journal of Clinical Endocrinology and Metabolism , vol.78 , pp. 526-535
    • Iranmanesh, A.1    Grisso, B.2    Veldhuis, J.D.3
  • 17
    • 33744953689 scopus 로고    scopus 로고
    • Effect of growth hormone (GH) treatment on the near-final height of 1258 patients with idiopathic GH deficiency: Analysis of a large international database
    • doi:10.1210/jc.2005-2284
    • Reiter EO, Price DA, Wilton P, Albertsson-Wikland K & Ranke MB. Effect of growth hormone (GH) treatment on the near-final height of 1258 patients with idiopathic GH deficiency: analysis of a large international database. Journal of Clinical Endocrinology and Metabolism 2006 91 2047-2054. (doi:10.1210/jc.2005-2284)
    • (2006) Journal of Clinical Endocrinology and Metabolism , vol.91 , pp. 2047-2054
    • Reiter, E.O.1    Price, D.A.2    Wilton, P.3    Albertsson-Wikland, K.4    Ranke, M.B.5
  • 20
    • 0035999443 scopus 로고    scopus 로고
    • The effects of growth hormone replacement therapy on bone metabolism in adult-onset growth hormone deficiency: A 2-year open randomized controlled multicenter trial
    • doi:10.1359/jbmr.2002.17.6.1081
    • Bex M, Abs R, Maiter D, Beckers A, Lamberigts G & Bouillon R. The effects of growth hormone replacement therapy on bone metabolism in adult-onset growth hormone deficiency: a 2-year open randomized controlled multicenter trial. Journal of Bone and Mineral Research 2002 17 1081-1094. (doi:10.1359/jbmr.2002.17.6.1081)
    • (2002) Journal of Bone and Mineral Research , vol.17 , pp. 1081-1094
    • Bex, M.1    Abs, R.2    Maiter, D.3    Beckers, A.4    Lamberigts, G.5    Bouillon, R.6
  • 21
    • 0345828935 scopus 로고    scopus 로고
    • Clinical pharmacological aspects of growth hormone administration
    • doi:10.1016/j.ghir.2003.10.001
    • Laursen T. Clinical pharmacological aspects of growth hormone administration. Growth Hormone & IGF Research 2004 14 16-44. (doi:10.1016/j.ghir.2003.10.001)
    • (2004) Growth Hormone & IGF Research , vol.14 , pp. 16-44
    • Laursen, T.1
  • 22
    • 0030007487 scopus 로고    scopus 로고
    • Two weeks of daily injections and continuous infusion of recombinant human growth hormone (GH) in GH-deficient adults: I. Effects on insulin-like growth factor-I (IGF-I), GH and IGF binding proteins, and glucose homeostasis
    • doi:10.1016/S0026-0495(96)90292-9
    • Johansson JO, Oscarsson J, Bjarnason R & Bengtsson BA. Two weeks of daily injections and continuous infusion of recombinant human growth hormone (GH) in GH-deficient adults: I. Effects on insulin-like growth factor-I (IGF-I), GH and IGF binding proteins, and glucose homeostasis. Metabolism 1996 45 362-369. (doi:10.1016/S0026-0495(96)90292-9)
    • (1996) Metabolism , vol.45 , pp. 362-369
    • Johansson, J.O.1    Oscarsson, J.2    Bjarnason, R.3    Bengtsson, B.A.4
  • 23
    • 0029881479 scopus 로고    scopus 로고
    • Two weeks of daily injections and continuous infusion of recombinant human growth hormone (GH) in GH-deficient adults. II. Effects on serum lipoproteins and lipoprotein and hepatic lipase activity
    • doi:10.1016/S0026-0495(96)90293-0
    • Oscarsson J, Ottosson M, Johansson JO, Wiklund O, Marin P, Bjorntorp P & Bengtsson BA. Two weeks of daily injections and continuous infusion of recombinant human growth hormone (GH) in GH-deficient adults. II. Effects on serum lipoproteins and lipoprotein and hepatic lipase activity. Metabolism 1996 45 370-377. (doi:10.1016/S0026-0495(96)90293-0)
    • (1996) Metabolism , vol.45 , pp. 370-377
    • Oscarsson, J.1    Ottosson, M.2    Johansson, J.O.3    Wiklund, O.4    Marin, P.5    Bjorntorp, P.6    Bengtsson, B.A.7
  • 24
    • 0032435064 scopus 로고    scopus 로고
    • Different effects of continuous and intermittent patterns of growth hormone administration on lipoprotein levels in growth hormone-deficient patients
    • doi:10.1159/000023292
    • Laursen T, Lemming L, Jorgensen JO, Klausen IC & Christiansen JS. Different effects of continuous and intermittent patterns of growth hormone administration on lipoprotein levels in growth hormone-deficient patients. Hormone Research 1998 50 284-291. (doi:10.1159/000023292)
    • (1998) Hormone Research , vol.50 , pp. 284-291
    • Laursen, T.1    Lemming, L.2    Jorgensen, J.O.3    Klausen, I.C.4    Christiansen, J.S.5
  • 26
    • 0036290740 scopus 로고    scopus 로고
    • A long-acting human growth hormone (Nutropin Depot): Efficacy and safety following two years of treatment in children with growth hormone deficiency
    • doi:10.1515/JPEM.2002.15.S2.715
    • Silverman BL, Blethen SL, Reiter EO, Attie KM, Neuwirth RB & Ford KM. A long-acting human growth hormone (Nutropin Depot): efficacy and safety following two years of treatment in children with growth hormone deficiency. Journal of Pediatric Endocrinology and Metabolism 2002 15 (Supplement 2) 715-722. (doi:10.1515/JPEM.2002.15.S2.715)
    • (2002) Journal of Pediatric Endocrinology and Metabolism , vol.15 , Issue.SUPPL. 2 , pp. 715-722
    • Silverman, B.L.1    Blethen, S.L.2    Reiter, E.O.3    Attie, K.M.4    Neuwirth, R.B.5    Ford, K.M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.