Saizen    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
78Hypopituitarism22

78. Hypopituitarism    [ 462 clinical trials,   346 drugs,   (DrugBank: 45 drugs),   41 drug target genes,   80 drug target pathways]
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
22 / 462 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01806298
(ClinicalTrials.gov)
June 20135/3/2013An 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 DeficiencyDrug: Saizen® solution for injection (referred as Saizen®)Merck KGaANULLCompleted18 Years65 YearsAll78Phase 4Australia;Germany;Sweden;United Kingdom;Czech Republic
2EUCTR2012-004263-47-CZ
(EUCTR)
13/05/201305/03/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-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 KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
3EUCTR2012-004263-47-DE
(EUCTR)
03/04/201325/02/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-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 KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
4EUCTR2012-004263-47-SE
(EUCTR)
06/03/201314/01/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-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: SAIZENMerck KGaANULLNot RecruitingFemale: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
5EUCTR2012-004263-47-GB
(EUCTR)
01/03/201308/01/2013Exploration if Saizen marketed solution for injection induces an immunogenic reactionOpen-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 KGaANULLNot Recruiting Female: yes
Male: yes
77Phase 4Czech Republic;Australia;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01494779
(ClinicalTrials.gov)
March 201328/11/2011Evaluation 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 RetardationDrug: SomatropinL.A.L Clinica Pesquisa e Desenvolvimento Ltda.NULLNot yet recruiting18 Years32 YearsMale32Phase 1Brazil
7EUCTR2011-000460-10-CZ
(EUCTR)
22/08/201122/06/2011Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst 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. GenevaNULLNot RecruitingFemale: yes
Male: yes
395Phase 4France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy
8EUCTR2011-000460-10-ES
(EUCTR)
16/08/201121/06/2011Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst 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. GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
395Phase 4United Kingdom;Czech Republic;Canada;Argentina;France;Spain;Italy
9EUCTR2011-000460-10-GB
(EUCTR)
03/08/201117/05/2011Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patientsFirst 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 SANULLNot RecruitingFemale: yes
Male: yes
395Phase 4Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom
10EUCTR2009-017011-16-SE
(EUCTR)
16/06/201104/05/2011Treatment of the low IGF-1 syndrome associated with Chronic Heart Failure: A Randomized, Placebo-Controlled, Double-Blind StudyTreatment 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 IINULLNot RecruitingFemale: no
Male: no
Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-023430-23-GB
(EUCTR)
28/03/201124/01/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3bHungary;Czech Republic;United Kingdom
12EUCTR2010-023430-23-CZ
(EUCTR)
09/02/201125/11/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3bHungary;United Kingdom;Czech Republic
13EUCTR2010-023430-23-HU
(EUCTR)
17/01/201110/11/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3bHungary;United Kingdom;Czech Republic
14NCT01237340
(ClinicalTrials.gov)
October 20105/11/2010Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity StudyA 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 SeronoNULLTerminated18 Years60 YearsAll59Phase 3United States
15EUCTR2010-019374-32-HU
(EUCTR)
13/09/201018/05/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-019374-32-SK
(EUCTR)
15/07/201014/05/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Hungary;Germany;Czech Republic;Slovakia;Slovenia
17NCT01034735
(ClinicalTrials.gov)
July 200816/12/2009r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence TrialPhase 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 VolunteersGrowth Failure;Growth Hormone DeficiencyBiological: r-hGH liquid (Saizen);Biological: r-hGH freeze-driedEMD SeronoNULLCompleted18 Years45 YearsBoth30Phase 1Germany
18NCT01187550
(ClinicalTrials.gov)
March 200722/8/2010Predictive 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, PituitaryDrug: Recombinant human growth hormone (r-hGH)Merck KGaAMerck Serono Co., Ltd., ChinaCompletedN/AN/AAll214Phase 4NULL
19NCT00256126
(ClinicalTrials.gov)
May 31, 200518/11/2005Predictive 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 SyndromeDrug: SaizenMerck KGaA, Darmstadt, GermanyNULLCompleted2 Years16 YearsAll318Phase 4Argentina;Australia;Austria;Canada;France;Germany;Italy;Norway;Russian Federation;Singapore;Spain;Sweden;United Kingdom
20NCT00109733
(ClinicalTrials.gov)
January 20052/5/2005Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone DeficiencyA 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 DwarfismBiological: recombinant human growth hormoneEMD SeronoNULLCompleted13 Years25 YearsAll31Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01157793
(ClinicalTrials.gov)
September 20036/7/2010A 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 AdulthoodA 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 AdulthoodDwarfism;Growth Hormone DeficiencyDrug: r-hGHMerck KGaANULLCompleted14 Years25 YearsBoth34Phase 4NULL
22EUCTR2015-001569-20-Outside-EU/EEA
(EUCTR)
06/07/2015Predictive 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: SaizenMerck Serono Co., Ltd.NULLNAFemale: yes
Male: yes
214Phase 4China