Polyethylene glycol ( DrugBank: Polyethylene glycol )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病1
78下垂体前葉機能低下症1
96クローン病2
97潰瘍性大腸炎2
235副甲状腺機能低下症8
276軟骨無形成症7
299嚢胞性線維症3

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04730245
(ClinicalTrials.gov)
June 1, 201825/1/2021Microbiota Modification for the Treatment of Motor Complication of Parkinson´s DiseaseTargeting Gut Microbiota for Motor Complications in Parkinson´s DiseaseParkinson's Disease AggravatedDrug: sodium phosphate enema, oral rifaximin and polyethylene glycolTorre Médica SantéNULLCompleted18 YearsN/AAll14Phase 1Mexico

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100048579
2021-08-012021-07-11Efficacy and Safety of JINTROLONG for Transitional Growth Hormone DeficiencyEfficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency (TGHD) Transitional Growth Hormone DeficiencyExperimental group:polyethylene glycol recombinant human growth hormone injection;The Children's Hospital of Zhejiang University School of MedicineNULLPending26BothExperimental group:23;Phase 4China

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
1NCT03476317
(ClinicalTrials.gov)
July 12, 20188/1/2018Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseAn Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseCrohn DiseaseDrug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: FluconazoleChildren's Hospital of PhiladelphiaUniversity of Pennsylvania;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed6 YearsN/AAll10Phase 2United States
2NCT02765256
(ClinicalTrials.gov)
August 20162/5/2016Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseFundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's DiseaseCrohn's DiseaseDrug: Fluconazole;Drug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: Promethazine;Drug: Fluconazole placeboUniversity of PennsylvaniaChildren's Hospital of Philadelphia;Crohn's and Colitis FoundationCompleted18 Years75 YearsAll8Phase 2United States

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03581149
(ClinicalTrials.gov)
March 26, 201827/3/2018Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis PatientsTolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled TrialUlcerative ColitisDrug: Sodium Picosulfate/Magnesium Citrate Laxative;Drug: 2L polyethylene glycol/ascorbic acidAmerican University of Beirut Medical CenterNULLRecruiting18 Years65 YearsAll68Phase 4Lebanon
2NCT01929668
(ClinicalTrials.gov)
August 201323/8/2013Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC PatientsComparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter StudyUlcerative ColitisDrug: polyethylene glycol;Drug: Ascorbic AcidKyungpook National UniversityNULLCompleted18 Years80 YearsBoth114N/AKorea, Republic of

235. 副甲状腺機能低下症


臨床試験数 : 88 薬物数 : 107 - (DrugBank : 24) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 7
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003380-26-FR
(EUCTR)
15/03/202127/10/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleava
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
2EUCTR2020-003380-26-IT
(EUCTR)
21/01/202124/05/2021PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism - PaTHway Trial Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-
Product Name: TransCon PTH mid-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-
Product Name: TransCon PTH high-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Te
Ascendis Pharma Bone Disease A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3France;United States;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
3EUCTR2020-003380-26-HU
(EUCTR)
08/01/202102/11/2020PaTHway TRIAL: A Clinical Trial to Investigate the Safety and Effectiveness of TransCon PTH Administered as an Injection Under the Skin in Adults with Hypoparathyroidism.A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism Hypoparathyroidism in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleava
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 3United States;France;Hungary;Canada;Denmark;Norway;Germany;United Kingdom;Italy
4EUCTR2018-004815-33-IT
(EUCTR)
18/11/201917/06/2021PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Product Name: TransCon PTH mid-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Product Name: TransCon PTH high-dose pen
Product Code: [TransCon PTH]
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Disease A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;United Kingdom;Italy
5EUCTR2018-004815-33-GB
(EUCTR)
08/10/201906/02/2020PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;United Kingdom
6EUCTR2018-004815-33-NO
(EUCTR)
27/09/201920/03/2019PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;Norway;Italy;United Kingdom
7EUCTR2018-004815-33-DK
(EUCTR)
05/07/201927/05/2019PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), A
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany;United Kingdom
8EUCTR2018-004815-33-DE
(EUCTR)
28/03/2019PaTH Forward: a study to investigate the safety and efficacy of TransCon PTH administered as an injection under the skin daily in adults with hypoparathyroidism.A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism. - PaTH Forward Hypoparathyroidism (HP) in Adults
MedDRA version: 20.0;Level: PT;Classification code 10021041;Term: Hypoparathyroidism;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: TransCon PTH low-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH mid-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Other descriptive name: POLY(OXY-1,2-ETHANEDIYL), ALPHA-HYDRO-OMEGA-METHOXY, ETHER WITH N-[[[2-[[6-[[1-[3-[[3-(2,3-DIHYDROXYPROPOXY)PROPYL]AMINO]-3-OXOPROPYL]-2,5-DIOXO-3-PYRROLIDINYL]THIO]HEXYL]AMINO]ETHYL]AMINO]CARBONYL]-2-METHYLALANYL-TERIPARATIDE (2:1)
Product Name: TransCon PTH high-dose pen
Product Code: TransCon PTH
INN or Proposed INN: Teriparatide conjugated to a multiarm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Bone Diseases A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Denmark;Germany

276. 軟骨無形成症


臨床試験数 : 51 薬物数 : 34 - (DrugBank : 6) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-002954-25-DK
(EUCTR)
24/01/202302/12/2022A phase 2b clinical trial to evaluate efficacy and safety of weekly doses of TransCon CNP compared with placebo in participants with achondroplasia aged 2 to 11 years of ageApproaCH: A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial evaluating Efficacy and Safety of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Children with Achondroplasia followed by an Open Label Extension period - ApproaCH Achondroplasia (ACH) in prepubertal children
MedDRA version: 25.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-type natriuretic peptide conjugated to a multi-arm polyethylene glycol carrier molecule through a cleavable linker
Ascendis Pharma Growth Disorders A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;Canada;Spain;Ireland;Australia;Denmark;United Kingdom;New Zealand
2EUCTR2019-002754-22-PT
(EUCTR)
05/02/202118/06/2020A Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of TransCon CNP in prepubertal children with achondroplasia followed by an Open-Label Extension PeriodACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 52 weeks in prepubertal children with achondroplasia followed by an Open-Label Extension Period - ACcomplisH Achondroplasia (ACH) in prepubertal children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Ascendis Pharma Growth Disorders A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Canada;Spain;Ireland;Denmark;Austria;Australia;Germany;United Kingdom;Switzerland;New Zealand
3EUCTR2019-002754-22-DE
(EUCTR)
28/07/202001/10/2019A Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of TransCon CNP in prepubertal children with achondroplasiaACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 12 months in prepubertal children with achondroplasia - ACcomplisH Achondroplasia (ACH) in prepubertal children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Ascendis Pharma Growth Disorders A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Canada;Australia;Denmark;Germany;New Zealand
4EUCTR2019-002754-22-DK
(EUCTR)
02/07/202012/05/2020A Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of TransCon CNP in prepubertal children with achondroplasia followed by an Open-Label Extension PeriodACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 52 weeks in prepubertal children with achondroplasia followed by an Open-Label Extension Period - ACcomplisH Achondroplasia (ACH) in prepubertal children
MedDRA version: 25.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Ascendis Pharma Growth Disorders A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Canada;Spain;Ireland;Austria;Australia;Denmark;Germany;United Kingdom;Switzerland;New Zealand
5EUCTR2019-002754-22-AT
(EUCTR)
09/06/202031/10/2019A Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of TransCon CNP in prepubertal children with achondroplasia followed by an Open-Label Extension PeriodACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 52 weeks in prepubertal children with achondroplasia followed by an Open-Label Extension Period - ACcomplisH Achondroplasia (ACH) in prepubertal children
MedDRA version: 25.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Ascendis Pharma Growth Disorders A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Canada;Spain;Ireland;Denmark;Australia;Austria;Germany;United Kingdom;Switzerland;New Zealand
6EUCTR2019-002754-22-IE
(EUCTR)
01/11/201903/09/2019A Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of TransCon CNP in prepubertal children with achondroplasia followed by an Open-Label Extension PeriodACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 52 weeks in prepubertal children with achondroplasia followed by an Open-Label Extension Period. - ACcomplisH Achondroplasia (ACH) in prepubertal children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Ascendis Pharma Growth Disorders A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Canada;Spain;Ireland;Denmark;Austria;Australia;Germany;United Kingdom;Switzerland;New Zealand
7EUCTR2019-002754-22-GB
(EUCTR)
09/09/2019A Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of TransCon CNP in prepubertal children with achondroplasiaACcomplisH: A Phase 2, multicenter, double-blind, randomized, placebo-controlled, dose escalation trial evaluating safety, efficacy, and pharmacokinetics of subcutaneous doses of TransCon CNP administered once weekly for 12 months in prepubertal children with achondroplasia - ACcomplisH Achondroplasia (ACH) in prepubertal children
MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: TransCon CNP 3.9 mg CNP-38/vial
Product Code: TransCon CNP
INN or Proposed INN: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Other descriptive name: C-TYPE NATRIURETIC PEPTIDE CONJUGATED TO MULTI-ARM POLYETHYLENE GLYCOL CARRIER THROUGH A CLEAVABLE LINKER
Ascendis Pharma Growth Disorders A/SNULLNAFemale: yes
Male: yes
60Phase 2Portugal;United States;Spain;Ireland;Austria;United Kingdom;Italy;Switzerland;Canada;Australia;Denmark;Germany;New Zealand

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
1NCT04458129
(ClinicalTrials.gov)
July 8, 202030/6/2020Polyethylene Glycol and Intestinal Inflammation in Cystic FibrosisEFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDRENCystic FibrosisDrug: Treatment with polyethylene glycol (Macrogol 4000)University Hospital, BordeauxNULLNot yet recruiting4 Years17 YearsAll23Phase 2NULL
2EUCTR2019-004958-29-FR
(EUCTR)
07/04/202004/06/2020Polyethylene glycol and intestinal inflammation in cystic fibrosisEFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN - MUCOLAX Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: FORLAX 4 g, poudre pour solution buvable en sachetCHU de BordeauxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 2France
3NCT04210427
(ClinicalTrials.gov)
December 12, 201918/12/2019Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal TransitCystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal TransitCystic Fibrosis Gastrointestinal DiseaseDrug: Polyethylene Glycol 3350;Device: SmartPill Motility System & PillCam Patency CapsuleSt. Louis UniversityNULLRecruiting18 Years40 YearsAll15Phase 4United States