265. 脂肪萎縮症 Lipodystrophy Clinical trials / Disease details


臨床試験数 : 116 薬物数 : 170 - (DrugBank : 61) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 97

  
9 trials found
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1EUCTR2015-000493-35-GR
(EUCTR)
29/02/201604/01/2016Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 19.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
Ionis Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
2EUCTR2015-000493-35-DE
(EUCTR)
17/02/201614/08/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 20.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
Akcea Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
3EUCTR2015-000493-35-PT
(EUCTR)
15/02/201608/10/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 20.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
Akcea TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
60Phase 2;Phase 3United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
4NCT02639286
(ClinicalTrials.gov)
December 23, 201523/12/2015Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label ExtensionA Randomized, Double Blind, Placebo-Controlled Study to Assess Efficacy, Safety and Tolerability of ISIS 304801 in Patients With Partial Lipodystrophy With an Open-Label ExtensionLipodystrophyDrug: ISIS 304801;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompleted18 YearsN/AAll5Phase 2United States
5EUCTR2015-000493-35-NL
(EUCTR)
15/12/201530/10/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 18.1;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
Isis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
125Phase 3United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Germany
6EUCTR2015-000493-35-IT
(EUCTR)
04/12/201519/01/2021Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneouslyto Patients with Familial Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 21.1;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
IONIS PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
125Phase 2;Phase 3United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Germany;Netherlands
7EUCTR2015-000493-35-ES
(EUCTR)
04/12/201515/10/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 18.1;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
Isis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
125Phase 2;Phase 3Portugal;United States;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Netherlands;Germany;Australia;Poland;Brazil
8EUCTR2015-000493-35-BE
(EUCTR)
09/11/201525/09/2015Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study Partial lipodystrophy
MedDRA version: 19.0;Level: PT;Classification code 10053857;Term: Partial lipodystrophy;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide
Product Code: ISIS 304801
INN or Proposed INN: ISIS 304801
Other descriptive name: ISIS 304801
Ionis Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
125 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
9NCT02527343
(ClinicalTrials.gov)
October 31, 201517/8/2015The BROADEN Study: A Study of Volanesorsen (Formerly ISIS-APOCIIIRx) in Patients With Familial Partial LipodystrophyA Randomized, Double-Blind, Placebo-Controlled, With an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Partial LipodystrophyFamilial Partial LipodystrophyDrug: volanesorsen;Drug: PlaceboIonis Pharmaceuticals, Inc.Akcea TherapeuticsActive, not recruiting18 YearsN/AAll60Phase 2/Phase 3United States;Belgium;Brazil;Canada;Germany;Greece;Israel;Italy;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom