LUMASIRAN ( DrugBank: Lumasiran )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
234ペルオキシソーム病(副腎白質ジストロフィーを除く。)20

234. ペルオキシソーム病(副腎白質ジストロフィーを除く。)


臨床試験数 : 39 薬物数 : 35 - (DrugBank : 12) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 45
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT04125472
(ClinicalTrials.gov)
June 2, 202110/10/2019Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1Primary HyperoxaluriaDrug: LumasiranAlnylam PharmaceuticalsNULLApproved for marketingN/AN/AAllBelgium;Canada;France;French Polynesia;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom;United States
2EUCTR2019-001346-17-IT
(EUCTR)
14/05/202107/06/2021A Phase 3 study of an Investigational Drug, Lumasiran (ALN-GO1) in patients with advanced primary hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1) - ILLUMINATE-C Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: [ALN-GO1]
INN or Proposed INN: Lumasiran
ALNYLAM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United Arab Emirates;United States;Lebanon;Turkey;Israel;United Kingdom;Switzerland;Italy;India;Egypt;France;Jordan;Belgium;Australia;Netherlands;Germany
3EUCTR2019-001346-17-GB
(EUCTR)
22/01/202023/07/2019A Phase 3 study of an Investigational Drug, Lumasiran (ALN-GO1) in patients with advanced primary hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1) Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: Lumasiran
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 3United Arab Emirates;United States;Lebanon;Turkey;Israel;United Kingdom;Switzerland;India;Egypt;France;Jordan;Belgium;Australia;Netherlands;Germany
4NCT04152200
(ClinicalTrials.gov)
January 21, 202031/10/2019A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 (PH1)Primary Hyperoxaluria Type 1;Primary HyperoxaluriaDrug: LumasiranAlnylam PharmaceuticalsNULLActive, not recruitingN/AN/AAll21Phase 3United States;Australia;Belgium;France;Israel;Italy;Jordan;Lebanon;Netherlands;Turkey;United Arab Emirates;Switzerland;United Kingdom
5EUCTR2019-001346-17-NL
(EUCTR)
05/12/201922/08/2019A Phase 3 study of an Investigational Drug, Lumasiran (ALN-GO1) in patients with advanced primary hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1) Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 3United States;United Arab Emirates;Lebanon;Turkey;Israel;Switzerland;United Kingdom;India;Egypt;France;Jordan;Belgium;Australia;Netherlands;Germany
6EUCTR2019-001346-17-BE
(EUCTR)
07/10/201921/08/2019A Phase 3 study of an Investigational Drug, Lumasiran (ALN-GO1) in patients with advanced primary hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1) Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 3United States;Egypt;United Kingdom;United Arab Emirates;Switzerland;India;Lebanon;Netherlands;Turkey;Belgium;Italy;Israel;Australia;France;Jordan;Germany
7EUCTR2018-004014-17-DE
(EUCTR)
23/04/201927/12/2018A Study of an Investigational Drug, Lumasiran (ALN-GO1) in Infants and Young Children with Primary Hyperoxaluria Type 1ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3France;United States;Israel;Germany;United Kingdom
8NCT03905694
(ClinicalTrials.gov)
April 22, 20191/4/2019A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1Primary Hyperoxaluria;Primary Hyperoxaluria Type 1 (PH1)Drug: LumasiranAlnylam PharmaceuticalsNULLActive, not recruiting0 Years5 YearsAll18Phase 3United States;France;Germany;Israel;United Kingdom
9EUCTR2018-001981-40-NL
(EUCTR)
21/03/201921/01/2019A Phase 3 Study of an Investigational Drug, Lumasiran (ALN-GO1) with an Extended Dosing Period in Children and Adults with Primary Hyperoxaluria Type 1 DiseaseILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study with an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: lumasiran
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3France;United States;United Arab Emirates;Jordan;Israel;Germany;Netherlands;United Kingdom;Japan;Switzerland
10EUCTR2018-004014-17-GB
(EUCTR)
01/03/201919/12/2018A Study of an Investigational Drug, Lumasiran (ALN-GO1) in Infants and Young Children with Primary Hyperoxaluria Type 1ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Israel;Germany;United Kingdom
11EUCTR2018-004014-17-FR
(EUCTR)
19/02/201926/12/2018A Study of an Investigational Drug, Lumasiran (ALN-GO1) in Infants and Young Children with Primary Hyperoxaluria Type 1ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
8 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Israel;Germany;United Kingdom
12EUCTR2018-001981-40-DE
(EUCTR)
17/12/201811/09/2018A Phase 3 Study of an Investigational Drug, Lumasiran (ALN-GO1) with an Extended Dosing Period in Children and Adults with Primary Hyperoxaluria Type 1 DiseaseILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study with an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: lumasiran
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 3France;United States;United Arab Emirates;Jordan;Israel;Netherlands;Germany;Switzerland;United Kingdom
13NCT03681184
(ClinicalTrials.gov)
November 27, 201819/9/2018A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1ILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study With an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1Primary Hyperoxaluria Type 1 (PH1)Drug: Placebo;Drug: LumasiranAlnylam PharmaceuticalsNULLActive, not recruiting6 YearsN/AAll39Phase 3United States;France;Germany;Israel;Netherlands;Switzerland;United Arab Emirates;United Kingdom
14EUCTR2018-001981-40-GB
(EUCTR)
20/11/201807/08/2018A Phase 3 Study of an Investigational Drug, Lumasiran (ALN-GO1) with an Extended Dosing Period in Children and Adults with Primary Hyperoxaluria Type 1 DiseaseILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study with an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: lumasiran
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
39 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;United Arab Emirates;Jordan;Israel;Netherlands;Germany;Switzerland;United Kingdom
15NCT03350451
(ClinicalTrials.gov)
April 4, 201817/11/2017An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Patients With Primary Hyperoxaluria Type 1A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients With Primary Hyperoxaluria Type 1PH1;Primary Hyperoxaluria;RNAi Therapeutic;siRNA;AGTDrug: LumasiranAlnylam PharmaceuticalsNULLActive, not recruiting6 YearsN/AAll20Phase 2France;Germany;Israel;Netherlands;United Kingdom
16EUCTR2016-003134-24-DE
(EUCTR)
28/12/201711/07/2017Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: lumasiran
Other descriptive name: ALN-65585
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;United States;United Arab Emirates;Jordan;Israel;Netherlands;Germany;United Kingdom
17EUCTR2016-003134-24-GB
(EUCTR)
20/12/201730/08/2017Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: lumasiran
Other descriptive name: ALN-65585
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2France;Israel;Netherlands;Germany;United Kingdom
18NCT02706886
(ClinicalTrials.gov)
March 8, 20163/3/2016Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1A Phase 1/2, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered ALN-GO1 in Healthy Adult Subjects, and Patients With Primary Hyperoxaluria Type 1Primary Hyperoxaluria Type 1 (PH1)Drug: Lumasiran;Drug: PlaceboAlnylam PharmaceuticalsNULLCompleted6 Years64 YearsAll52Phase 1/Phase 2France;Germany;Israel;Netherlands;United Kingdom;Jordan;United States
19EUCTR2019-001346-17-DE
(EUCTR)
15/07/2019A Phase 3 study of an Investigational Drug, Lumasiran (ALN-GO1) in patients with advanced primary hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1) Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
20Phase 3United Arab Emirates;United States;Lebanon;Turkey;Israel;Switzerland;United Kingdom;India;Egypt;France;Jordan;Belgium;Australia;Netherlands;Germany
20EUCTR2019-001346-17-FR
(EUCTR)
12/07/2019A Phase 3 study of an Investigational Drug, Lumasiran (ALN-GO1) in patients with advanced primary hyperoxaluria Type 1ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1) Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 20.1;Level: PT;Classification code 10020703;Term: Hyperoxaluria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: lumasiran
Product Code: ALN-GO1
INN or Proposed INN: LUMASIRAN
Alnylam Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
16Phase 3United Arab Emirates;United States;Lebanon;Turkey;Israel;Switzerland;United Kingdom;India;France;Egypt;Belgium;Australia;Netherlands;Germany