Solaris ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
62Paroxysmal nocturnal hemoglobinuria3
109Atypical hemolytic uremic syndrome1

62. Paroxysmal nocturnal hemoglobinuria


Clinical trials : 271 Drugs : 163 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 106
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004438-39-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
2EUCTR2020-004438-39-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 IncNULLAuthorised-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
3EUCTR2020-004438-39-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

109. Atypical hemolytic uremic syndrome


Clinical trials : 115 Drugs : 37 - (DrugBank : 7) / Drug target genes : 3 - Drug target pathways : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003916-37-GB
(EUCTR)
13/04/201819/02/2018Stopping Eculizumab Treatment Safely in atypical Haemolytic Uraemic Syndrome (SETS aHUS)Multicentre, open label, prospective, single arm study of the safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome - SETS aHUS: Stopping Eculizumab Treatment Safely in aHUS Atypical Haemolytic Uraemic Syndrome (aHUS);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Solaris
Product Name: Solaris
INN or Proposed INN: Eculizumab
Other descriptive name: IgG2/4?
Newcastle Upon Tyne Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom