TransCon CNP ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
276軟骨無形成症8

276. 軟骨無形成症


臨床試験数 : 46 薬物数 : 29 - (DrugBank : 6) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 30
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT05246033
(ClinicalTrials.gov)
January 5, 20229/2/2022A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With AchondroplasiaACcomplisH China: A Phase 2, Multicenter, Randomized, Placebo-controlled, Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With AchondroplasiaAchondroplasiaDrug: TransCon CNP;Drug: Placebo for TransCon CNPAscendis Pharma A/SNULLRecruiting2 Years10 YearsAll64Phase 2China
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: 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;Austria;Australia;Denmark;Germany;United Kingdom;Switzerland;New Zealand
5NCT04085523
(ClinicalTrials.gov)
June 24, 20209/9/2019A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly 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 52 Weeks in Prepubertal Children With Achondroplasia Followed by an Open-Label Extension PeriodAchondroplasiaDrug: TransCon CNP;Drug: Placebo for TransCon CNP;Drug: sWfI Placebo for TransCon CNPAscendis Pharma A/SNULLEnrolling by invitation2 Years10 YearsAll60Phase 2United States;Australia;Austria;Denmark;Germany;Ireland;New Zealand
6EUCTR2019-002754-22-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: 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;Australia;Austria;Germany;United Kingdom;Switzerland;New Zealand
7EUCTR2019-002754-22-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
8EUCTR2019-002754-22-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