Isis 304801    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
265Lipodystrophy8

265. Lipodystrophy    [ 109 clinical trials,   164 drugs,   (DrugBank: 59 drugs),   26 drug target genes,   94 drug target pathways]
Searched query = "Lipodystrophy", "Berardinelli-Seip syndrome", "Lawrence syndrome", "Barraquer-Simons syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
8 / 109 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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]
Ionis Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
125Phase 3United 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]
Akcea TherapeuticsNULLNot Recruiting Female: yes
Male: yes
60Phase 2;Phase 3Portugal;United States;Greece;Spain;Turkey;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Belgium;Brazil;Netherlands;Germany
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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
125Phase 2;Phase 3Portugal;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-000493-35-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;Brazil;Poland;Australia;Germany;Netherlands
7EUCTR2015-000493-35-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]
Ionis Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
125Phase 3United States;Portugal;Greece;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Germany;Netherlands
8NCT02527343
(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