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RF26 | PSAT150 Growth Outcomes From the Phase 2 and Phase 3 Studies of Once Weekly Somatrogon vs Daily Genotropin in Pediatric Patients With Growth Hormone Deficiency: Comparisons With Published Literature and an International Growth Study Database

Autor: Jose Cara, Martin Carlsson, Ron G Rosenfeld, Michael P Wajnrajch, Ronnie Wang, Zvi Zadik

Publikováno v: Journal of the Endocrine Society. 6:A647-A647

Background Somatrogon is a long-acting recombinant human growth hormone (hGH) currently in development as a once-weekly injectable treatment for children with growth hormone deficiency (GHD). In a phase 2 (NCT01592500) and a phase 3 (NCT02968004) stu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::968f40c8e057f29a601225825d7a8632
https://doi.org/10.1210/jendso/bvac150.1338

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OR10-04 Interpretation of Insulin-like Growth Factor-1 (IGF-1) Levels Following Administration of Somatrogon (a Long-acting Human Growth Hormone - hGH-CTP)

Autor: Dennis M Fisher, John Choe, Aleksandra Pastrak, Michael Wajnrajch, Jose Cara

Publikováno v: Journal of the Endocrine Society

IGF-1 is often used as a biomarker to evaluate the efficacy and safety of hGH replacement therapy. Typically, the mean IGF-1 SDS level during the dosing interval, rather than the peak value, guides clinical decision-making: sustained mean values > +2

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3317c7e9a55f54ec272419d84f202ca5
http://europepmc.org/articles/PMC7209021

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OR10-06 Somatrogon Growth Hormone in the Treatment of Pediatric Growth Hormone Deficiency: Results of the Pivotal Pediatric Phase 3 Clinical Trial

Autor: Michael Wajnrajch, Cheri Deal, Jose Cara, Aleksandra Pastrak, Lawrence A. Silverman, Srinivas Rao Valluri

Publikováno v: Journal of the Endocrine Society

Background: Somatrogon (hGH-CTP) is a long acting recombinant human growth hormone (rhGH; somatropin) in development for once weekly treatment of children with growth hormone deficiency (GHD). Somatrogon contains the amino acid sequence of hGH and th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::838ce34e3179eecfe4eda21ead0c0572
http://europepmc.org/articles/PMC7207981

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SUN-LB080 ACROSTUDY - Safety and Efficacy of a Cohort of 110 Naïve Patients with Acromegaly Treated with Pegvisomant

Autor: Cecilia Camacho-Hübner, Susan M. Webb, Nicky Kelepouris, Michael Wajnrajch, Maria Fleseriu, Jane Loftus, Andrew Palladino, Thierry Brue, Roy Gomez, Judith Hey-Hadavi, Srinivas Rao Valluri, Roberto Salvatori, Jose Cara, Joli van der Lans

Publikováno v: Journal of the Endocrine Society

Background: ACROSTUDY is an open-label, non-interventional post-authorization safety study that began in 2004 to evaluate safety in at least 1000 acromegaly patients treated with the GH receptor antagonist pegvisomant (PEGV). This commitment was fulf

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4948d1846b0d09a412834f699cc42b19
http://europepmc.org/articles/PMC6553204

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SUN-LB079 Acrostudy - Safety And Treatment Outcomes In 2221 Patients With Acromegaly Treated With Pegvisomant: Real World Experience

Autor: Roy Gomez, Roberto Salvatori, Thierry Brue, Maria Fleseriu, Natasa Rajicic, Srinivas Rao Valluri, Judith Hey-Hadavi, Cecilia Camacho-Hübner, Jose Cara, Michael Wajnrajch, Nicky Kelepouris, Ezio Ghigo, Joli van der Lans, Andrew Palladino

Publikováno v: Journal of the Endocrine Society

ACROSTUDY is an open-label, non-interventional post-authorization safety study (PASS) that began in 2004 to evaluate safety in at least 1000 acromegaly patients treated for 5 years with the GH receptor antagonist pegvisomant (PEGV). This commitment w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e1ad7ff3c75ec609adb3b131ecd02c9
https://doi.org/10.1210/js.2019-sun-lb079

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Weight gain in Turner Syndrome: association to puberty induction? - longitudinal analysis of KIGS data

Autor: Cecilia Camacho-Hübner, Anders Lindberg, Jose Cara, Dionisis Chrysis, Christina Toschke, Thomas Reinehr

Publikováno v: Clinical Endocrinology. 85:85-91

SummaryContext Girls with Turner Syndrome (TS) treated or not treated with growth hormone (GH) are prone to overweight. Therefore, we hypothesize that puberty induction in TS is associated with weight gain. Methods We analyzed weight changes (BMI-SDS

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2cf46771e458f3af850e70c20c4f782d
https://doi.org/10.1111/cen.13044

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Treatment with high doses of pegvisomant in 56 patients with acromegaly: experience from ACROSTUDY

Autor: Jose Cara, Patrick Wilton, Ann-Charlotte Åkerblad, Aart Jan van der Lely, Peter Jonsson, Ezio Ghigo

Publikováno v: European Journal of Endocrinology, 175(4), 239-245. Bioscientifica Ltd

Objective To investigate the characteristics of patients who need more or less pegvisomant (PEGV) to normalize serum IGF-I. Design ACROSTUDY is a global noninterventional safety surveillance study of long-term treatment outcomes in patients treated w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::27915a4c0ae20ad7754288b73ce9306b
https://doi.org/10.1530/EJE-16-0008

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Overall and cause-specific mortality in GH-deficient adults on GH replacement

Autor: Ann-Charlotte Åkerblad, Anders F Mattsson, Jose Cara, Rolf-Christian Gaillard, Bengt-Åke Bengtsson, Maria Koltowska-Häggström, Bernhard Saller, Patrick Wilton, Ulla Feldt-Rasmussen, John P. Monson, Roger Abs

Publikováno v: European Journal of Endocrinology. 166:1069-1077

ObjectiveHypopituitarism is associated with an increased mortality rate but the reasons underlying this have not been fully elucidated. The purpose of this study was to evaluate mortality and associated factors within a large GH-replaced population o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::300185322f5c97e8d74c18ba64fc3ecc
https://doi.org/10.1530/eje-11-1028

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