210. 単心室症
［臨床試験数：47，薬物数：54（DrugBank：23），標的遺伝子数：32，標的パスウェイ数：66］
Searched query = "Single Ventricle", "SV", "Single ventricle heart defect", "Univentricular heart", "UVH", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | EUCTR2018-002821-45-CZ (EUCTR) | 29/04/2020 | 23/03/2020 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | France;United States;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom | ||
| 2 | EUCTR2018-002821-45-DK (EUCTR) | 27/02/2019 | 02/01/2019 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Australia;Denmark;Germany;United Kingdom;New Zealand;China | ||
| 3 | EUCTR2016-003320-23-GB (EUCTR) | 11/10/2017 | 08/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom | ||
| 4 | EUCTR2016-003320-23-DE (EUCTR) | 12/09/2017 | 11/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | France;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom | ||
| 5 | EUCTR2016-003320-23-DK (EUCTR) | 25/08/2017 | 19/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Australia;Denmark;Germany;United Kingdom;New Zealand;China | ||
| 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 |
| 6 | EUCTR2018-002821-45-DE (EUCTR) | 27/12/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | France;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom | |||
| 7 | EUCTR2018-002821-45-GB (EUCTR) | 28/12/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand |