Denosumab ( DrugBank: Denosumab )


8 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ15
50皮膚筋炎/多発性筋炎1
70広範脊柱管狭窄症1
93原発性胆汁性胆管炎3
95自己免疫性肝炎1
96クローン病1
274骨形成不全症25
299嚢胞性線維症1

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02418273
(ClinicalTrials.gov)
August 1, 20196/4/2015Denosumab for Glucocorticoid-treated Children With Rheumatic DisordersDenosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot StudyOsteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced OsteoporosisDrug: denosumabIndiana UniversityNULLWithdrawn4 Years16 YearsAll0Phase 1/Phase 2United States
2JPRN-JapicCTI-184229
12/9/201803/12/2018Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg SyringeInvestigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study- Rheumatoid ArthritisIntervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab)
INN of the intervention : denosumab
Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
DAIICHISANKYO Co., Ltd.NULLotherBOTH2000NAJapan
3JPRN-jRCTs071180018
13/04/201815/02/2019Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT. Rheumatoid arthritisPatients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.
Kawakami AtsushiNULLComplete>= 20age oldNot applicableBoth44Phase 4Japan
4JPRN-UMIN000030575
2018/03/3126/12/2017Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. Rheumatoid arthritisPatients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.
Daiichi Sankyo Company, LimitedNULLComplete: follow-up complete20years-oldNot applicableMale and Female44Not applicableJapan
5JPRN-UMIN000030828
2018/01/1515/01/2018The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. - EVIDENCE study Rheumatoid ArthritisOsteoporosiszoledronic acid
denosumab
Osaka City University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female500Not selectedJapan
6JPRN-JapicCTI-173747
01/11/201725/10/2017Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis - Rheumatoid ArthritisIntervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab)
INN of the intervention : denosumab
Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
DAIICHISANKYO Co., Ltd.NULLcompleteBOTH1000NAJapan
7JPRN-UMIN000028376
2017/07/2601/08/2017Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritisStudy of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis rheumatoid arthritisCombination of anti-rheumatic therapy and denosumab
Anti-rheumatic therapy alone
Hokkaido Medical Center for Rheumatic DiseasesNULLComplete: follow-up complete20years-old75years-oldMale and Female30Not selectedJapan
8NCT03239080
(ClinicalTrials.gov)
June 19, 20171/8/2017Effect of Denosumab in Erosion Healing in RAEffect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCTRheumatoid ArthritisDrug: Denosumab;Other: PlaceboChinese University of Hong KongNULLCompleted18 YearsN/AAll110Phase 2China
9JPRN-UMIN000014737
2014/08/0101/08/2014The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. - Two Birds trial rheumatoid arthritisDenosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D.
BP group: Patients take BP continuously. All patients are to take vitamin D.
Yokohama City University Medical CenterNULLComplete: follow-up complete50years-old90years-oldMale and Female286Not selectedJapan
10JPRN-JapicCTI-132277
01/10/2013AMG 162 Phase III study (DESIRABLE study)A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III) rheumatoid arthritisIntervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection
Control intervention name : Placebo
Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection
DAIICHISANKYO Co.,Ltd.NULL20BOTH642Phase 3NULL
11NCT01973569
(ClinicalTrials.gov)
October 201325/10/2013AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) TreatmentA Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)Rheumatoid ArthritisDrug: denosumab;Drug: placeboDaiichi Sankyo, Inc.NULLCompleted20 YearsN/AAll679Phase 3Japan
12NCT01770106
(ClinicalTrials.gov)
December 20123/1/2013RA Denosumab on Bone Microstructure StudyComparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled TrialRheumatoid ArthritisDrug: Denosumab;Drug: AlendronateChinese University of Hong KongNULLCompleted18 Years80 YearsFemale40Phase 4Hong Kong
13NCT01294397
(ClinicalTrials.gov)
March 201113/1/2011Effects of Denosumab on the Pharmacokinetics of EtanerceptThe Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid ArthritisPostmenopausal;Osteopenia;Rheumatoid Arthritis;OsteoporosisDrug: Etanercept;Drug: DenosumabAmgenNULLTerminated45 Years80 YearsFemale19Phase 1United States
14JPRN-JapicCTI-101263
01/8/2010DRIVEA Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II) Rheumatoid ArthritisIntervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneously for placebo
DAIICHISANKYO Co.,Ltd.NULL2075BOTH320Phase 2NULL
15NCT00095498
(ClinicalTrials.gov)
August 20045/11/2004Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid ArthritisA Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: placebo;Drug: denosumabAmgenNULLCompleted18 YearsN/AAll227Phase 2United States

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02418273
(ClinicalTrials.gov)
August 1, 20196/4/2015Denosumab for Glucocorticoid-treated Children With Rheumatic DisordersDenosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot StudyOsteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced OsteoporosisDrug: denosumabIndiana UniversityNULLWithdrawn4 Years16 YearsAll0Phase 1/Phase 2United States

70. 広範脊柱管狭窄症


臨床試験数 : 95 薬物数 : 169 - (DrugBank : 61) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 90
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100053054
2021-11-092021-11-10Desomumab and lumbar spinal stenosisEvaluation of bone mineral density and function at 1 year after lumbar spinal stenosis and fusion with desomumab: a parallel double-blind randomized controlled clinical trial Lumber diseaseGroup A:Denosumab;Group B:Placebo;The First Affiliated Hospital (Shenzhen People's Hospital), Southern University of Science and TechnologyNULLRecruiting4090BothGroup A:40;Group B:40;Phase 4China

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000031384
2018/03/1620/02/2018Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) - Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) PBC patients with osteoporosisDenosumab group
(60 mg Denosumab is administered subcutaneously every 6 month)
Zoledronic acid group
(5 mg Zoledronic acid is administered intravenously every 12 month)
Tokai University School of MedicineMinistry of Health, Labour and WelfareComplete: follow-up complete20years-old89years-oldMale and Female80Not selectedJapan
2JPRN-UMIN000012489
2013/12/0404/12/2013Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosisEfficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis - Efficacy of Denosumab for osteoporosis patients with PBC Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 monthsFor osteoporosis patients who need treatment based on PBC treatment guideline, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. PBC patients who do not meet osteoporosis treatment criteria will be followed.Juntendo University School of MedicineNULLComplete: follow-up continuing20years-oldNot applicableMale and Female20Not applicableJapan
3JPRN-UMIN000012193
2013/11/0101/11/2013Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosisEfficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis - Denosumab versus Bisphosphonate for osteoporosis in patients with PBC Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonateDiscontinue the administration of aredoron acid, risedronic acid, and minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not applicableJapan

95. 自己免疫性肝炎


臨床試験数 : 52 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000013659
2014/04/0808/04/2014Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) - Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months<Test A; Randomization test: 1)2)>
In patients pretreated with bisphosphonates;
1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.

<Test A; Randomization test: 1)2)>
2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.

<Test B; newly intervention>
In patients who were not pretreated with bisphosphonates; 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
Juntendo University School of MedicineNULLComplete: follow-up continuing20years-old75years-oldMale and Female80Not applicableJapan

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02321280
(ClinicalTrials.gov)
February 201511/12/2014The Efficacy of Denosumab in Active Crohn's DiseaseDenosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's DiseaseCrohn DiseaseDrug: DenosumabUniversity of ManitobaUniversity of Toronto;McMaster UniversityCompleted18 Years80 YearsAll2Phase 1/Phase 2Canada

274. 骨形成不全症


臨床試験数 : 91 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000550-21-BG
(EUCTR)
01/12/202011/09/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
2EUCTR2014-000184-40-PL
(EUCTR)
13/10/202015/01/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
3EUCTR2018-000550-21-DE
(EUCTR)
18/09/202020/02/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - Prolia Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
4EUCTR2018-000550-21-CZ
(EUCTR)
31/03/202014/02/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
5EUCTR2018-000550-21-ES
(EUCTR)
01/10/201905/07/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
6EUCTR2018-000550-21-IT
(EUCTR)
21/06/201915/06/2021Study to Assess Long term Safety and Efficacy of Current or PriorTreatment with Denosumab in Children/Young Adults with OsteogenesisImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta - NA Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: [AMG 162]
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
AMGEN INC.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany
7EUCTR2018-000550-21-GB
(EUCTR)
07/03/201917/06/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
8NCT03638128
(ClinicalTrials.gov)
July 26, 201821/6/2018Open-label Extension Denosumab Study in Children and Young Adults With Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis ImperfectaOsteogenesis Imperfecta (OI)Drug: Denosumab;Other: No treatment;Drug: Alternative osteoporosis medicationsAmgenNULLCompleted5 Years20 YearsAll75Phase 3United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom
9EUCTR2018-000550-21-HU
(EUCTR)
06/07/201810/05/2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
10NCT02352753
(ClinicalTrials.gov)
June 24, 201528/1/2015Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OITo Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OIOsteogenesis ImperfectaDrug: DenosumabAmgenNULLCompleted2 Years17 YearsAll153Phase 3United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;United Kingdom;Czech Republic
11EUCTR2014-000184-40-BE
(EUCTR)
22/05/201523/02/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
12EUCTR2014-000184-40-GB
(EUCTR)
30/01/201526/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3France;United States;Hungary;Czech Republic;Canada;Belgium;Poland;Spain;Australia;Bulgaria;Germany;United Kingdom
13EUCTR2014-000184-40-DE
(EUCTR)
29/12/201422/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
14EUCTR2014-000184-40-ES
(EUCTR)
19/10/201401/09/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 17.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
15EUCTR2014-000184-40-HU
(EUCTR)
18/10/201429/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 19.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
16EUCTR2014-000184-40-CZ
(EUCTR)
11/09/201412/08/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
17EUCTR2012-002887-29-DE
(EUCTR)
13/02/201307/11/2012New therapeutic approach in OI with the antibody DenosumabTranslational therapy in patients with Osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AK In this study we will evaluate the efficacy of Denosumab in children with Osteogenesis imperfecta. Subjects will be treated every 12 weeks over 36 weeks with Denosumab 1mg/kg body weight s.c.. Efficacy will be evaluated by DXA measurements of the spine for bone mineral density.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Prolia
Product Name: Denusomab
INN or Proposed INN: DENOSUMAB
Other descriptive name: DENOSUMAB
University of CologneNULLNot RecruitingFemale: yes
Male: yes
Germany
18NCT01799798
(ClinicalTrials.gov)
February 201314/2/2013Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody DenosumabTRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMABOsteogenesis ImperfectaDrug: DenosumabUniversity of CologneNULLCompleted5 Years11 YearsBoth10Phase 2Germany
19EUCTR2014-000184-40-Outside-EU/EEA
(EUCTR)
26/11/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 17.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: denosumab - - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen Inc.NULLNAFemale: yes
Male: yes
150United States;Australia;Canada
20EUCTR2014-000184-40-IT
(EUCTR)
15/06/2021Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta - Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in OSTEOGENESIS IMPERFECTA
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA - 120 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 1.7 ML 4 FLACONCINI
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: DENOSUMAB
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
AMGEN INC.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany
21EUCTR2014-000184-40-BG
(EUCTR)
05/12/2014Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany
22EUCTR2018-000550-21-PL
(EUCTR)
16/10/2018Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany
23EUCTR2018-000550-21-FR
(EUCTR)
27/07/2020Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
24EUCTR2018-000550-21-BE
(EUCTR)
14/01/2019Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis ImperfectaMulticenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta Osteogenesis Imperfecta (OI)
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen IncNULLNAFemale: yes
Male: yes
150Phase 3United States;Czechia;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany
25EUCTR2014-000184-40-FR
(EUCTR)
18/06/2015Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis ImperfectaProspective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, andPharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta Osteogenesis Imperfecta
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: XGEVA
Product Name: Denosumab
Product Code: AMG 162
INN or Proposed INN: Denosumab
Other descriptive name: Denosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
Amgen, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Finland;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03921060
(ClinicalTrials.gov)
September 2, 202126/3/2019Markers of Osteoporosis in Cystic FibrosisMarkers of Osteoporosis in Cystic FibrosisCystic FibrosisDrug: DenosumabUniversity of Texas Southwestern Medical CenterNULLRecruiting18 Years64 YearsAll100Phase 4United States