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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-000493-35-GR (EUCTR) | 29/02/2016 | 04/01/2016 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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. | NULL | Not 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): no | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 2 | EUCTR2015-000493-35-DE (EUCTR) | 17/02/2016 | 14/08/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 3 | EUCTR2015-000493-35-PT (EUCTR) | 15/02/2016 | 08/10/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 4 | NCT02639286 (ClinicalTrials.gov) | December 23, 2015 | 23/12/2015 | Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension | A Randomized, Double Blind, Placebo-Controlled Study to Assess Efficacy, Safety and Tolerability of ISIS 304801 in Patients With Partial Lipodystrophy With an Open-Label Extension | Lipodystrophy | Drug: ISIS 304801;Drug: Placebo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | N/A | All | 5 | Phase 2 | United States |
| 5 | EUCTR2015-000493-35-NL (EUCTR) | 15/12/2015 | 30/10/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 3 | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Germany | ||
| 6 | EUCTR2015-000493-35-ES (EUCTR) | 04/12/2015 | 15/10/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Netherlands;Germany;Australia;Poland;Brazil | ||
| 7 | EUCTR2015-000493-35-IT (EUCTR) | 04/12/2015 | 19/01/2021 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2;Phase 3 | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Germany;Netherlands | ||
| 8 | EUCTR2015-000493-35-BE (EUCTR) | 09/11/2015 | 25/09/2015 | Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy | A 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. | NULL | Not 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): no | United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands | ||
| 9 | NCT02527343 (ClinicalTrials.gov) | October 31, 2015 | 17/8/2015 | The BROADEN Study: A Study of Volanesorsen (Formerly ISIS-APOCIIIRx) in Patients With Familial Partial Lipodystrophy | A 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 | Familial Partial Lipodystrophy | Drug: volanesorsen;Drug: Placebo | Ionis Pharmaceuticals, Inc. | Akcea Therapeutics | Active, not recruiting | 18 Years | N/A | All | 60 | Phase 2/Phase 3 | United States;Belgium;Brazil;Canada;Germany;Greece;Israel;Italy;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom |