Sotatercept - 45 mg/vial ( DrugBank: Sotatercept )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症4

86. 肺動脈性肺高血圧症


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005061-13-NL
(EUCTR)
09/02/202225/11/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
2EUCTR2020-005061-13-PL
(EUCTR)
26/01/202202/12/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
3EUCTR2020-005061-13-SE
(EUCTR)
10/01/202212/10/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Brazil;Belgium;Poland;Croatia;United States;Portugal;Serbia;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Germany;New Zealand;Sweden
4EUCTR2020-005061-13-DE
(EUCTR)
22/06/202124/02/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden