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 | 23 |
78. 下垂体前葉機能低下症
臨床試験数 : 492 / 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 100
Showing 1 to 10 of 23 diseases
| 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 | EUCTR2016-004580-39-IT (EUCTR) | 18/07/2018 | 01/06/2021 | Treatment of Growth Hormone Deficiency in patient with Chronic Heart Failure | Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study - Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-B Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-B ... | Growth Hormone Deficiency associated with Chronic Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Growth Hormone Deficiency associated with Chronic Heart Failure MedDRA version: 20.0;Level: PT;Class ... | Trade Name: SAIZEN - 1 FLACONCINO POLV. 8 MG + 1 CARTUCCIA. SOLV. INSERITI IN UN DISPOSITIVO PER LA RICOSTITUZIONE Product Name: somatropina Product Code: [026863100] INN or Proposed INN: SOMATROPINA Other descriptive name: somatropin Trade Name: SAIZEN- 1 FLACONCINO POLV. 8 MG + 1 CARTUCCIA. SOLV. INSERITI IN UN DISPOSITIVO PER LA R ... | AOU FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 64 | Phase 3 | Italy | ||
| 2 | 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) An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjec ... | 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) Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Form ... | 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 |
| 3 | 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 Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid form ... | 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] Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Gr ... | 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-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 Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid form ... | 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] Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Gr ... | 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 | ||
| 5 | 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) Open-label, single-arm, phase IV, multicenter trial to explore theimmunogenicity of the liquid formu ... | 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] Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Gr ... | Trade Name: SAIZEN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 4 | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 6 | 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 Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid form ... | 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] Adult Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Gr ... | Trade Name: SAIZEN | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 77 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | Czech Republic;Australia;Germany;United Kingdom;Sweden | ||
| 7 | 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. Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Bl ... | 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 | |
| 8 | 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 Validation study for genetic markers for growth hormone treatment in growth hormone deficient and tu ... | 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 First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth H ... | 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] Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 13.1;Level: PT;Classificati ... | 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 Trade Name: Saizen8mg click.easy powder for solution for injection Product Name: NA Product Code: NA IN ... | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 9 | 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 Validation study for genetic markers for growth hormone treatment in growth hormone deficient and tu ... | 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 First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth H ... | 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] Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 14.0;Level: PT;Classificati ... | 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 Trade Name: Saizen8mg click.easy power for solution for injection Product Name: NA Product Code: NA INN ... | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 10 | 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 Validation study for genetic markers for growth hormone treatment in growth hormone deficient and tu ... | 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 First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth H ... | 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] idiopathic growth hormone deficientyTurner Syndrome MedDRA version: 13.1;Level: PT;Classification co ... | 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 Trade Name: Saizen8mg click.easy powder for solution for injection Product Name: Saizen8mg click.easy ... | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom |