DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
79	家族性高コレステロール血症（ホモ接合体）	2

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	EUCTR2019-003611-62-NO (EUCTR)	20/03/2020	28/11/2019	Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumab to Evaluate the Efficacy and Safety in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy.	Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. - LIB003-003	Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]	Product Code: LIB003 INN or Proposed INN: not available Other descriptive name: LIB003 Trade Name: Repatha (evolocumab) INN or Proposed INN: EVOLOCUMAB	LIB Therapeutics, LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	United States;Turkey;Israel;South Africa;Norway
2	NCT04034485 (ClinicalTrials.gov)	November 7, 2019	22/7/2019	Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH	Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy	Homozygous Familial Hypercholesterolemia	Drug: LIB003;Drug: evolocumab	LIB Therapeutics LLC	NULL	Enrolling by invitation	10 Years	N/A	All	70	Phase 3	United States;Israel;Norway;South Africa;Turkey

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

EUCTR2019-003611-62-NO
(EUCTR)

20/03/2020

28/11/2019

Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumab to Evaluate the Efficacy and Safety in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy.

Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. - LIB003-003

Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Product Code: LIB003
INN or Proposed INN: not available
Other descriptive name: LIB003
Trade Name: Repatha (evolocumab)
INN or Proposed INN: EVOLOCUMAB

LIB Therapeutics, LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Turkey;Israel;South Africa;Norway

NCT04034485
(ClinicalTrials.gov)

November 7, 2019

22/7/2019

Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH

Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy

Homozygous Familial Hypercholesterolemia

Drug: LIB003;Drug: evolocumab

LIB Therapeutics LLC

NULL

Enrolling by invitation

10 Years

N/A

All

Phase 3

United States;Israel;Norway;South Africa;Turkey