Sotatercept ( DrugBank: Sotatercept )


2 diseases
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43
284ダイアモンド・ブラックファン貧血1

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1NCT05587712
(ClinicalTrials.gov)
January 19, 202317/10/2022Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of CarePulmonary Arterial HypertensionDrug: SotaterceptMerck Sharp & Dohme LLCNULLRecruiting1 Year17 YearsAll42Phase 2United States
2EUCTR2022-000478-25-ES
(EUCTR)
23/12/202213/10/2022Sotatercept in Children with Pulmonary Artery Hypertension on Standard of CareA Phase 2 Open-label Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care - Sotatercept in Children with PAH on SoC Pulmonary arterial hypertension
MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Sotatercept
Product Code: MK-7962
INN or Proposed INN: Sotatercept
Merck Sharp & Dohme LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2United States;Spain;Turkey;Israel;Colombia;United Kingdom;France;Mexico;Poland;Australia;South Africa;Netherlands;Germany
3EUCTR2020-005061-13-AT
(EUCTR)
05/05/202202/12/2021A 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/ MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011/ MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
4EUCTR2020-005061-13-HR
(EUCTR)
14/04/202212/05/2022A 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 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
5EUCTR2020-005061-13-DK
(EUCTR)
25/03/202222/12/2021A 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 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
6NCT04811092
(ClinicalTrials.gov)
March 18, 202216/3/2021Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH PatientsPulmonary Arterial HypertensionDrug: Sotatercept;Other: PlaceboAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 YearsN/AAll662Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom
7EUCTR2020-005061-13-PT
(EUCTR)
18/03/202207/12/2021A 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 3Germany;New Zealand;Sweden;United 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
8EUCTR2020-005061-13-BE
(EUCTR)
07/03/202226/11/2021A 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 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden;Spain
9EUCTR2020-005061-13-CZ
(EUCTR)
02/03/202220/12/2021A 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 / MK - 7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
10EUCTR2020-005061-13-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;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
11EUCTR2021-001498-21-DE
(EUCTR)
01/02/202224/09/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality 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
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
166Phase 3France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy
12EUCTR2021-001498-21-IT
(EUCTR)
26/01/202210/09/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: [ACE-011]
ACCELERON PHARMA INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 3France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy
13EUCTR2020-005061-13-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/ MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Czechia;Portugal;Greece;Austria;Sweden;Netherlands;Poland;Brazil;Korea, Republic of;France;Serbia;Croatia;Colombia;Argentina;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany
14EUCTR2021-000199-12-IT
(EUCTR)
26/01/202209/09/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- andHigh-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3Serbia;United States;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
15EUCTR2021-000199-12-HR
(EUCTR)
19/01/202203/02/2022A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
16EUCTR2020-005061-13-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
17EUCTR2021-003020-32-ES
(EUCTR)
03/01/202219/10/2021A Phase 2 Study of Sotatercept for Combined Postcapillary and Precapillary Pulmonary Hypertension TreatmentPhase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) - A Phase 2 Study of Sotatercept for Cpc-PH Treatment Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved EjectionFraction (HFpEF)
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
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: SOTATERCEPT
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden
18EUCTR2021-000199-12-DK
(EUCTR)
16/12/202123/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
19NCT04896008
(ClinicalTrials.gov)
December 1, 202113/5/2021A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk MortalityPulmonary Arterial HypertensionDrug: Sotatercept;Other: PlaceboAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 Years75 YearsAll200Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom
20EUCTR2021-000199-12-CZ
(EUCTR)
29/11/202110/09/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
21EUCTR2021-001498-21-NL
(EUCTR)
15/11/202114/09/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality 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
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
166Phase 3France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;Italy
22EUCTR2021-000199-12-AT
(EUCTR)
12/11/202126/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
23EUCTR2021-001498-21-ES
(EUCTR)
11/11/202131/08/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality 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
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
166Phase 3France;United States;Mexico;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;United Kingdom;Italy
24EUCTR2021-000199-12-ES
(EUCTR)
27/10/202123/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
25EUCTR2021-000199-12-NL
(EUCTR)
20/10/202130/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
26EUCTR2021-000199-12-DE
(EUCTR)
19/10/202119/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden;Austria;United Kingdom;Czech Republic;Canada;Serbia;United States;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia
27EUCTR2021-000199-12-SE
(EUCTR)
04/10/202105/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients 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
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
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
28EUCTR2020-005061-13-ES
(EUCTR)
06/07/202108/07/2021A 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
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 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
29EUCTR2020-004142-11-PL
(EUCTR)
24/06/202123/03/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of 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
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
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
30EUCTR2020-004142-11-IT
(EUCTR)
23/06/202108/06/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of 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
Product Code: [ACE-011]
ACCELERON PHARMA INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3Serbia;United States;Czechia;Spain;Korea, Democratic People's Republic of;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
31EUCTR2020-005061-13-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
32EUCTR2020-004142-11-DE
(EUCTR)
12/05/202119/01/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of 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
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
284Phase 3Argentina;United States;Czechia;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Sweden;Netherlands;Czech Republic;Belgium;Ireland;Brazil;Korea, Republic of;Poland;Mexico;Italy;Israel;Australia;France;Serbia;Germany
33NCT04796337
(ClinicalTrials.gov)
May 12, 202122/2/2021A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004)An 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 PAHPulmonary Arterial Hypertension;PAHBiological: SotaterceptAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 YearsN/AAll700Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom
34EUCTR2020-004142-11-BE
(EUCTR)
15/04/202108/02/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of 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
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
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
35EUCTR2020-004142-11-SE
(EUCTR)
26/03/202128/01/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of 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
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
284Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
36EUCTR2020-004142-11-NL
(EUCTR)
24/03/202117/02/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of 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
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
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
37NCT04576988
(ClinicalTrials.gov)
January 25, 202128/9/2020A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAHPulmonary Arterial HypertensionBiological: Sotatercept;Drug: Placebo;Drug: Background PAH TherapyAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLCompleted18 YearsN/AAll324Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Serbia;Spain;Sweden;Switzerland;United Kingdom
38EUCTR2017-004738-27-BE
(EUCTR)
04/01/201931/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom
39EUCTR2017-004738-27-GB
(EUCTR)
18/10/201824/06/2019A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
40EUCTR2017-004738-27-ES
(EUCTR)
04/09/201805/09/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
41EUCTR2017-004738-27-DE
(EUCTR)
15/08/201803/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom
42NCT03496207
(ClinicalTrials.gov)
June 13, 201829/3/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Placebo;Drug: SotaterceptAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLCompleted18 YearsN/AAll106Phase 2United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom
43EUCTR2020-005061-13-GR
(EUCTR)
14/03/2022A 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 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01464164
(ClinicalTrials.gov)
January 201231/10/2011Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan AnemiaPhase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan AnemiaDiamond Blackfan AnemiaDrug: Sotatercept;Drug: Sotatercept with prednisone boostNorthwell HealthNULLRecruiting18 YearsN/AAll20Phase 1/Phase 2United States