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Efficacy and safety of a biosimilar recombinant human growth hormone (r-hGH Cristalia) compared with reference r-hGH in children with growth hormone deficiency (CERES study): A randomized, multicentric, investigator-blind, phase 3 trial.

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Title: Efficacy and safety of a biosimilar recombinant human growth hormone (r-hGH Cristalia) compared with reference r-hGH in children with growth hormone deficiency (CERES study): A randomized, multicentric, investigator-blind, phase 3 trial.
Authors: Czepielewski MA; Serviço de Endocrinologia, Hospital de Clínicas de Porto Alegre, UFRGS, Porto Alegre, RS, Brazil. Electronic address: mczepielewski@hcpa.edu.br., Garret Q; CEDOES, Vitória, ES, Brazil., Vencio SAC; ICF - Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda, Aparecida de Goiânia, GO, Brazil., Rassi N; Hospital Alberto Rassi - HGG, Goiânia, GO, Brazil., Felicio JS; Hospital Universitário João de Barros Barreto, Universidade Federal do Pará, Belém, PA, Brazil., Faria MS; Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA, São Luis, MA, Brazil., Senn CCP; Centro de Diabetes de Curitiba, Curitiba, PR, Brazil., Bronstein MD; CPQUALI Pesquisa Clínica Ltda, São Paulo, SP, Brazil., Cerqueira MJAG; Instituto de Ensino e Pesquisa Clínica do Ceará, Fortaleza, CE, Brazil., Neves ACL; Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, PE, Brazil., Sgarbi JA; Unidade de Pesquisa Clínica de Marília Ltda (UpCliM), Marília, SP, Brazil., Spinola-Castro AM; Universidade Federal de São Paulo - UNIFESP/EPM, São Paulo, SP, Brazil., Cunha MPR; CAEP - Centro Avançado de Estudos e Pesquisas Ltda, Campinas, SP, Brazil., Bandeira F; Centro de Pesquisas Médicas Básica e Clínica Ltda, Recife, PE, Brazil., Toffoletto O; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil., Afiune J; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil., Baradelli R; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil., Rodrigues DG; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil., Scharf M; Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.
Source: Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society [Growth Horm IGF Res] 2019 Oct - Dec; Vol. 48-49, pp. 29-35. Date of Electronic Publication: 2019 Aug 02.
Publication Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Elsevier Country of Publication: Scotland NLM ID: 9814320 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-2238 (Electronic) Linking ISSN: 10966374 NLM ISO Abbreviation: Growth Horm IGF Res Subsets: MEDLINE
Database: MEDLINE Ultimate
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PubType: Academic Journal
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  Data: Efficacy and safety of a biosimilar recombinant human growth hormone (r-hGH Cristalia) compared with reference r-hGH in children with growth hormone deficiency (CERES study): A randomized, multicentric, investigator-blind, phase 3 trial.
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  Data: <searchLink fieldCode="AU" term="%22Czepielewski+MA%22">Czepielewski MA</searchLink>; Serviço de Endocrinologia, Hospital de Clínicas de Porto Alegre, UFRGS, Porto Alegre, RS, Brazil. Electronic address: mczepielewski@hcpa.edu.br.<br /><searchLink fieldCode="AU" term="%22Garret+Q%22">Garret Q</searchLink>; CEDOES, Vitória, ES, Brazil.<br /><searchLink fieldCode="AU" term="%22Vencio+SAC%22">Vencio SAC</searchLink>; ICF - Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda, Aparecida de Goiânia, GO, Brazil.<br /><searchLink fieldCode="AU" term="%22Rassi+N%22">Rassi N</searchLink>; Hospital Alberto Rassi - HGG, Goiânia, GO, Brazil.<br /><searchLink fieldCode="AU" term="%22Felicio+JS%22">Felicio JS</searchLink>; Hospital Universitário João de Barros Barreto, Universidade Federal do Pará, Belém, PA, Brazil.<br /><searchLink fieldCode="AU" term="%22Faria+MS%22">Faria MS</searchLink>; Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA, São Luis, MA, Brazil.<br /><searchLink fieldCode="AU" term="%22Senn+CCP%22">Senn CCP</searchLink>; Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.<br /><searchLink fieldCode="AU" term="%22Bronstein+MD%22">Bronstein MD</searchLink>; CPQUALI Pesquisa Clínica Ltda, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Cerqueira+MJAG%22">Cerqueira MJAG</searchLink>; Instituto de Ensino e Pesquisa Clínica do Ceará, Fortaleza, CE, Brazil.<br /><searchLink fieldCode="AU" term="%22Neves+ACL%22">Neves ACL</searchLink>; Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, PE, Brazil.<br /><searchLink fieldCode="AU" term="%22Sgarbi+JA%22">Sgarbi JA</searchLink>; Unidade de Pesquisa Clínica de Marília Ltda (UpCliM), Marília, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Spinola-Castro+AM%22">Spinola-Castro AM</searchLink>; Universidade Federal de São Paulo - UNIFESP/EPM, São Paulo, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Cunha+MPR%22">Cunha MPR</searchLink>; CAEP - Centro Avançado de Estudos e Pesquisas Ltda, Campinas, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Bandeira+F%22">Bandeira F</searchLink>; Centro de Pesquisas Médicas Básica e Clínica Ltda, Recife, PE, Brazil.<br /><searchLink fieldCode="AU" term="%22Toffoletto+O%22">Toffoletto O</searchLink>; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Afiune+J%22">Afiune J</searchLink>; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Baradelli+R%22">Baradelli R</searchLink>; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Rodrigues+DG%22">Rodrigues DG</searchLink>; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.<br /><searchLink fieldCode="AU" term="%22Scharf+M%22">Scharf M</searchLink>; Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.
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  Data: <searchLink fieldCode="JN" term="%229814320%22">Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society</searchLink> [Growth Horm IGF Res] 2019 Oct - Dec; Vol. 48-49, pp. 29-35. <i>Date of Electronic Publication: </i>2019 Aug 02.
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  Data: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>Scotland <i>NLM ID: </i>9814320 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1532-2238 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210966374%22">10966374 </searchLink><i>NLM ISO Abbreviation: </i>Growth Horm IGF Res <i>Subsets: </i>MEDLINE
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        Text: English
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              Text: 2019 Oct - Dec
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