BCX9930 ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
62発作性夜間ヘモグロビン尿症19
66IgA腎症3
222一次性ネフローゼ症候群4

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05741346
(ClinicalTrials.gov)
January 18, 202314/2/2023Long-term Safety of BCX9930 in Subjects With Paroxysmal Nocturnal HemoglobinuriaAn Open-label Study to Evaluate the Long-term Safety of BCX9930 Monotherapy in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Previously Received BCX9930 in a BioCryst-sponsored StudyParoxysmal Nocturnal HemoglobinuriaDrug: BCX9930BioCryst PharmaceuticalsNULLRecruiting18 YearsN/AAll30Phase 2Hungary;Malaysia
2EUCTR2020-004438-39-NL
(EUCTR)
04/10/202205/01/2022BCX9930 treatment in patients with an inadequate response to C5 inhibitorsA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Trade Name: Solaris
Product Name: eculizumab
Product Code: eculizumab
INN or Proposed INN: Eculizumab
Other descriptive name: Soliris
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ravulizumab
INN or Proposed INN: RAVULIZUMAB
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
81Phase 2United States;Taiwan;Slovakia;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;Netherlands;China;Japan;Korea, Republic of
3EUCTR2020-004403-14-CZ
(EUCTR)
31/03/202224/09/2021BCX9930 compared to placebo in the treatment of PNHA Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2United States;Serbia;Czechia;Spain;Turkey;Lithuania;Azerbaijan;Italy;Czech Republic;Canada;Argentina;Brazil;Poland;Romania;South Africa;Albania;China;Sweden
4NCT05116774
(ClinicalTrials.gov)
December 6, 20212/11/2021BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor TherapyA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor TherapyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: BCX9930;Drug: Eculizumab;Drug: RavulizumabBioCryst PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll81Phase 2France;Hungary;Italy;Spain;United Kingdom;Taiwan;United States
5EUCTR2020-004438-39-SK
(EUCTR)
29/11/202129/07/2021BCX9930 treatment in patients with an inadequate response to C5 inhibitorsA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Trade Name: Solaris
Product Name: eculizumab
Product Code: eculizumab
INN or Proposed INN: Eculizumab
Other descriptive name: Soliris
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ravulizumab
INN or Proposed INN: RAVULIZUMAB
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
81Phase 2United States;Taiwan;Slovakia;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
6EUCTR2020-004403-14-ES
(EUCTR)
11/11/202114/07/2021BCX9930 compared to placebo in the treatment of PNHA Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2Serbia;United States;Spain;Turkey;Lithuania;Azerbaijan;European Union;Canada;Argentina;Brazil;Albania;South Africa;China
7EUCTR2020-004438-39-IT
(EUCTR)
10/11/202127/01/2022BCX9930 treatment in PNH patients with an inadequate response to C5 inhibitorsA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ULTOMIRIS - 300 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 3 ML (100 MG / ML) - 1 FLACONCINO
Product Name: ravulizumab
Product Code: [ravulizumab]
INN or Proposed INN: Ravulizumab
Other descriptive name: Ultomiris
Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML)
Product Name: Eculizumab
Product Code: [Eculizumab]
INN or Proposed INN: ECULIZUMAB
Other descriptive name: Soliris
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 2United States;Taiwan;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
8EUCTR2020-004438-39-ES
(EUCTR)
02/11/202123/07/2021BCX9930 treatment in patients with an inadequate response to C5 inhibitorsA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Trade Name: Solaris
Product Name: eculizumab
Product Code: eculizumab
INN or Proposed INN: Eculizumab
Other descriptive name: Soliris
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ravulizumab
INN or Proposed INN: RAVULIZUMAB
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 2United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
9NCT05116787
(ClinicalTrials.gov)
October 26, 20212/11/2021BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor TherapyA Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNHParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: BCX9930 monotherapy;Drug: PlaceboBioCryst PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll57Phase 2Malaysia;South Africa;Spain;Taiwan;United States
10EUCTR2020-004403-14-IT
(EUCTR)
20/10/202122/10/2021BCX9930 compared to placebo in the treatment of PNHA Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2Serbia;United States;Spain;Lithuania;Turkey;Italy;Azerbaijan;European Union;Canada;Argentina;Brazil;Albania;South Africa;China
11EUCTR2020-004403-14-LT
(EUCTR)
14/10/202118/08/2021BCX9930 compared to placebo in the treatment of PNHA Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria - REDEEM 2 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
57Phase 2United States;Serbia;European Union;Canada;Argentina;Brazil;Turkey;Lithuania;South Africa;Albania;China;Azerbaijan
12EUCTR2020-004438-39-HU
(EUCTR)
01/09/202102/07/2021BCX9930 treatment in patients with an inadequate response to C5 inhibitorsA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Trade Name: Solaris
Product Name: eculizumab
Product Code: eculizumab
INN or Proposed INN: Eculizumab
Other descriptive name: Soliris
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ravulizumab
INN or Proposed INN: RAVULIZUMAB
BioCryst Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
81Phase 2United States;Taiwan;Slovakia;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;Netherlands;China;Japan;Korea, Republic of
13EUCTR2020-004438-39-FR
(EUCTR)
26/08/202116/06/2021BCX9930 treatment in patients with an inadequate response to C5 inhibitorsA Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy - REDEEM 1 Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Trade Name: Solaris
Product Name: eculizumab
Product Code: eculizumab
INN or Proposed INN: Eculizumab
Other descriptive name: Soliris
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ravulizumab
INN or Proposed INN: RAVULIZUMAB
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 2United States;Taiwan;Turkey;Colombia;United Kingdom;France;Hungary;European Union;Canada;Argentina;Brazil;China;Japan;Korea, Republic of
14NCT04702568
(ClinicalTrials.gov)
December 18, 20207/1/2021A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)Paroxysmal Nocturnal Hemoglobinuria;PNHDrug: BCX9930BioCryst PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll200Phase 2Austria;South Africa;United Kingdom
15EUCTR2020-000501-93-AT
(EUCTR)
27/11/202008/09/2020A long term study of BCX9930 in patients with PNHA Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2European Union;Denmark;Austria;South Africa;Italy;United Kingdom
16EUCTR2020-000501-93-IT
(EUCTR)
02/11/202025/01/2021A long term study of BCX9930 in patients with HPNA Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) - A long term study of BCX9930 in patients with HPN Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2European Union;Denmark;Austria;South Africa;United Kingdom;Italy
17EUCTR2020-000501-93-DK
(EUCTR)
27/10/202011/09/2020A long term study of BCX9930 in patients with PNHA Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2European Union;Austria;Denmark;South Africa;Italy;United Kingdom
18EUCTR2020-000501-93-GB
(EUCTR)
29/09/202009/07/2020A long term study of BCX9930 in patients with PNHA Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2European Union;South Africa;United Kingdom
19NCT04330534
(ClinicalTrials.gov)
March 3, 202023/3/2020First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNHA Phase 1 Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BCX9930 in Healthy Subjects and in Subjects With Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal HemoglobinuriaDrug: BCX9930;Drug: PlaceboBioCryst PharmaceuticalsNULLCompleted18 YearsN/AAll168Phase 1/Phase 2Austria;South Africa;United Kingdom

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005855-19-HU
(EUCTR)
03/11/202208/04/2022Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
42Phase 2France;Hungary;Spain;Romania;Germany;United Kingdom;Italy
2EUCTR2020-005855-19-ES
(EUCTR)
11/10/202105/08/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy
3EUCTR2020-005855-19-IT
(EUCTR)
01/10/202122/10/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005855-19-HU
(EUCTR)
03/11/202208/04/2022Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
42Phase 2France;Hungary;Spain;Romania;Germany;United Kingdom;Italy
2NCT05162066
(ClinicalTrials.gov)
October 29, 202126/11/2021BCX9930 for the Treatment of C3G, IgAN, and PMN (RENEW)An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects With C3G, IgAN, or PMNComplement 3 Glomerulopathy;Immunoglobulin A Nephropathy;Membranous NephropathyDrug: BCX9930BioCryst PharmaceuticalsNULLTerminated18 YearsN/AAll2Phase 2France;Italy;Spain;United Kingdom
3EUCTR2020-005855-19-ES
(EUCTR)
11/10/202105/08/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: BCX9930
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BioCryst Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy
4EUCTR2020-005855-19-IT
(EUCTR)
01/10/202122/10/2021Evaluating oral BCX9930 in renal diseasesAn Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy - RENEW complement 3 glomerulopathyimmunoglobulin A nephropathyprimary membranous nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.0;Classification code 10077827;Term: C3 glomerulopathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
Product Name: BCX9930
Product Code: [BCX9930]
INN or Proposed INN: BCX9930
Other descriptive name: BCX9930 hydrochloride
BIOCRYST PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France;Spain;Germany;United Kingdom;Italy