Saizen (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 78 | 下垂体前葉機能低下症 | 22 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01806298 (ClinicalTrials.gov) | June 2013 | 5/3/2013 | An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) | Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: Saizen® solution for injection (referred as Saizen®) | Merck KGaA | NULL | Completed | 18 Years | 65 Years | All | 78 | Phase 4 | Australia;Germany;Sweden;United Kingdom;Czech Republic |
| 2 | EUCTR2012-004263-47-CZ (EUCTR) | 13/05/2013 | 05/03/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD). - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2012-004263-47-DE (EUCTR) | 03/04/2013 | 25/02/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 4 | EUCTR2012-004263-47-SE (EUCTR) | 06/03/2013 | 14/01/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore theimmunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: SAIZEN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 5 | EUCTR2012-004263-47-GB (EUCTR) | 01/03/2013 | 08/01/2013 | Exploration if Saizen marketed solution for injection induces an immunogenic reaction | Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset - Saizen, Phase 4 study in Growth Hormone Deficiency | Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT01494779 (ClinicalTrials.gov) | March 2013 | 28/11/2011 | Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A. | GH Deficiency (GHD);Growth Retardation | Drug: Somatropin | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | NULL | Not yet recruiting | 18 Years | 32 Years | Male | 32 | Phase 1 | Brazil | |
| 7 | EUCTR2011-000460-10-CZ (EUCTR) | 22/08/2011 | 22/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 8 | EUCTR2011-000460-10-ES (EUCTR) | 16/08/2011 | 21/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy power for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 395 | Phase 4 | United Kingdom;Czech Republic;Canada;Argentina;France;Spain;Italy | ||
| 9 | EUCTR2011-000460-10-GB (EUCTR) | 03/08/2011 | 17/05/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | idiopathic growth hormone deficientyTurner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: Saizen 8mg click.easy powder for solution for injection Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom | ||
| 10 | EUCTR2009-017011-16-SE (EUCTR) | 16/06/2011 | 04/05/2011 | Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study | Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind Study | Low serum IGF-I and GH deficiency in patients with congestive heart failure;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Saizen Product Name: Saizen | University Federico II | NULL | Not Recruiting | Female: no Male: no | Sweden | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2010-023430-23-GB (EUCTR) | 28/03/2011 | 24/01/2011 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3b | Hungary;Czech Republic;United Kingdom | |||
| 12 | EUCTR2010-023430-23-CZ (EUCTR) | 09/02/2011 | 25/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3b | Hungary;United Kingdom;Czech Republic | |||
| 13 | EUCTR2010-023430-23-HU (EUCTR) | 17/01/2011 | 10/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3b | Hungary;United Kingdom;Czech Republic | |||
| 14 | NCT01237340 (ClinicalTrials.gov) | October 2010 | 5/11/2010 | Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study | A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) | Drug: Saizen® | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 59 | Phase 3 | United States |
| 15 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 17 | NCT01034735 (ClinicalTrials.gov) | July 2008 | 16/12/2009 | r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial | Phase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy Volunteers | Growth Failure;Growth Hormone Deficiency | Biological: r-hGH liquid (Saizen);Biological: r-hGH freeze-dried | EMD Serono | NULL | Completed | 18 Years | 45 Years | Both | 30 | Phase 1 | Germany |
| 18 | NCT01187550 (ClinicalTrials.gov) | March 2007 | 22/8/2010 | Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen® | Dwarfism, Pituitary | Drug: Recombinant human growth hormone (r-hGH) | Merck KGaA | Merck Serono Co., Ltd., China | Completed | N/A | N/A | All | 214 | Phase 4 | NULL |
| 19 | NCT00256126 (ClinicalTrials.gov) | May 31, 2005 | 18/11/2005 | Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN® | Growth Hormone Deficiency;Turner Syndrome | Drug: Saizen | Merck KGaA, Darmstadt, Germany | NULL | Completed | 2 Years | 16 Years | All | 318 | Phase 4 | Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom |
| 20 | NCT00109733 (ClinicalTrials.gov) | January 2005 | 2/5/2005 | Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency | A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS) | Childhood-onset Growth Hormone Deficiency;Pituitary Dwarfism | Biological: recombinant human growth hormone | EMD Serono | NULL | Completed | 13 Years | 25 Years | All | 31 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01157793 (ClinicalTrials.gov) | September 2003 | 6/7/2010 | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood | Dwarfism;Growth Hormone Deficiency | Drug: r-hGH | Merck KGaA | NULL | Completed | 14 Years | 25 Years | Both | 34 | Phase 4 | NULL |
| 22 | EUCTR2015-001569-20-Outside-EU/EEA (EUCTR) | 06/07/2015 | Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen® | Dwarfism, Pituitary MedDRA version: 18.0;Level: PT;Classification code 10013883;Term: Dwarfism;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen | Merck Serono Co., Ltd. | NULL | NA | Female: yes Male: yes | 214 | Phase 4 | China |