PB1046 ( DrugBank: - )


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8

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_
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PhaseCountries
1EUCTR2019-001598-10-AT
(EUCTR)
29/04/202123/01/2020Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic Pulmonary Arterial Hypertension
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: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
2EUCTR2019-001598-10-PL
(EUCTR)
26/05/202013/02/2020Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic Pulmonary Arterial Hypertension
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: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Czechia;Greece;Spain;Austria;Italy;Hungary;Poland;Belgium;Romania;Bulgaria;Germany
3EUCTR2019-001598-10-ES
(EUCTR)
28/02/202020/12/2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic Pulmonary Arterial Hypertension
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: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
4EUCTR2019-001598-10-GR
(EUCTR)
28/02/202013/12/2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic Pulmonary Arterial Hypertension
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: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
5EUCTR2019-001598-10-BG
(EUCTR)
12/02/202009/01/2020Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic Pulmonary Arterial Hypertension
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: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Romania;Bulgaria;Germany
6EUCTR2019-001598-10-HU
(EUCTR)
24/01/202010/12/2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly Subcutaneous Injections of PB1046 (study drug) in Subjects With Symptomatic Pulmonary Arterial HypertensionA Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous Injections of a Sustained-Release VIP Analogue, PB1046, in Adult Subjects with Symptomatic Pulmonary Arterial Hypertension Symptomatic Pulmonary Arterial Hypertension
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: Vasomera (PB1046) Injection
Product Code: PB1046
INN or Proposed INN: not available
Other descriptive name: PB1046, VIP-ELP1-120, Vasomera
PhaseBio Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
63Phase 2Serbia;United States;Greece;Spain;Austria;Italy;Hungary;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany
7NCT03795428
(ClinicalTrials.gov)
April 10, 201918/12/2018Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004Pulmonary Arterial HypertensionDrug: Pemziviptadil (PB1046) InjectionPhaseBio Pharmaceuticals Inc.NULLRecruiting18 Years79 YearsAll63Phase 2United States
8NCT03315507
(ClinicalTrials.gov)
October 20, 20172/10/2017A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAHAn Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: PB1046 Subcutaneous InjectionPhaseBio Pharmaceuticals Inc.NULLCompleted18 YearsN/AAll3Phase 1United States