234. ペルオキシソーム病(副腎白質ジストロフィーを除く。) Peroxisomal disease (except Adrenoleukodystrophy) Clinical trials / Disease details


臨床試験数 : 41 薬物数 : 37 - (DrugBank : 12) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 44

  
7 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2016-003134-24-NL
(EUCTR)
21/06/201828/09/2017Extension 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: 20.0;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: ALN-GO1
Product Code: ALN-GO1
INN or Proposed INN: ALN-65585
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;Germany;Netherlands;United Kingdom
2EUCTR2016-003134-24-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 2United States;United Arab Emirates;France;Jordan;Israel;Netherlands;Germany;United Kingdom
3EUCTR2016-003134-24-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
4EUCTR2016-003134-24-FR
(EUCTR)
09/10/201720/10/2017Extension 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: 20.0;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: ALN-GO1
Product Code: ALN-GO1
INN or Proposed INN: ALN-65585
Other descriptive name: ALN-65585
Alnylam Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2United States;United Arab Emirates;France;Jordan;Israel;Netherlands;Germany;United Kingdom
5EUCTR2015-004407-23-NL
(EUCTR)
06/06/201715/08/2016The First-in-Human Study of an Investigational Drug, ALN-GO1, in Healthy Adult Subjects and Patients with Primary Hyperoxaluria Type 1 DiseaseA 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 1 Primary Hyperoxaluria Type 1 (PH1)
MedDRA version: 19.0;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: ALN-GO1
Product Code: ALN-GO1
INN or Proposed INN: ALN-65585
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 1;Phase 2United States;France;Jordan;Israel;Germany;Netherlands;United Kingdom
6EUCTR2015-004407-23-GB
(EUCTR)
10/02/201621/12/2015The First-in-Human Study of an Investigational Drug, ALN-GO1, in Healthy Adult Subjects and Patients with Primary Hyperoxaluria Type 1 DiseaseA 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 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: ALN-GO1
Product Code: ALN-GO1
INN or Proposed INN: ALN-65585
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
52Phase 1;Phase 2United Kingdom;Germany;Netherlands;Israel;Jordan;France;United States
7EUCTR2015-004407-23-DE
(EUCTR)
07/03/2016The First-in-Human Study of an Investigational Drug, ALN-GO1, in Healthy Adult Subjects and Patients with Primary Hyperoxaluria Type 1 DiseaseA 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 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: ALN-GO1
Product Code: ALN-GO1
INN or Proposed INN: ALN-65585
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
52 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Jordan;Israel;Netherlands;Germany;United Kingdom