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 | 11 |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-005061-13-AT (EUCTR) | 05/05/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 2 | EUCTR2020-005061-13-HR (EUCTR) | 14/04/2022 | 12/05/2022 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 3 | EUCTR2020-005061-13-DK (EUCTR) | 25/03/2022 | 22/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 4 | EUCTR2020-005061-13-PT (EUCTR) | 18/03/2022 | 07/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Germany;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 | ||
| 5 | EUCTR2020-005061-13-BE (EUCTR) | 07/03/2022 | 26/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 6 | EUCTR2020-005061-13-CZ (EUCTR) | 02/03/2022 | 20/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 7 | EUCTR2020-005061-13-NL (EUCTR) | 09/02/2022 | 25/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United 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 | ||
| 8 | EUCTR2020-005061-13-PL (EUCTR) | 26/01/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United 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 | ||
| 9 | EUCTR2020-005061-13-SE (EUCTR) | 10/01/2022 | 12/10/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Brazil;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 | ||
| 10 | EUCTR2020-005061-13-DE (EUCTR) | 22/06/2021 | 24/02/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United 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 | ||
| 11 | EUCTR2020-005061-13-GR (EUCTR) | 14/03/2022 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 |