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
171	ウィルソン病	1

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	EUCTR2016-003876-29-DE (EUCTR)	15/09/2017	03/04/2017	Chelate Study: Trientine for the treatment of Wilson's disease	CHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease	Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms. MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]	Trade Name: Cuprior 150 mg film-coated tablets Product Name: TETA 4HCl Product Code: TETA 4HCl INN or Proposed INN: Trientine tetrahydrochloride Other descriptive name: TETA 4HCl Trade Name: Metalcaptase® 150 mg gastro-resistant tablet INN or Proposed INN: penicillamine Other descriptive name: penicillamine Trade Name: Metalcaptase® 300 mg gastro-resistant tablet INN or Proposed INN: penicillamine Other descriptive name: penicillamine	gmp-orphan SA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 3	Brazil;Belgium;Denmark;Austria;Germany;United Kingdom;United States;France;Poland;Italy;Sweden

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

EUCTR2016-003876-29-DE
(EUCTR)

15/09/2017

03/04/2017

Chelate Study: Trientine for the treatment of Wilson's disease

CHELATE STUDY: Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s disease

Wilson's disease (WD) is a life-threatening inborn error of copper metabolism leading to an excessive copper accumulation, mainly in the liver or brain, causing hepatic and neurologic severe symptoms.
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trade Name: Cuprior 150 mg film-coated tablets
Product Name: TETA 4HCl
Product Code: TETA 4HCl
INN or Proposed INN: Trientine tetrahydrochloride
Other descriptive name: TETA 4HCl
Trade Name: Metalcaptase® 150 mg gastro-resistant tablet
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine
Trade Name: Metalcaptase® 300 mg gastro-resistant tablet
INN or Proposed INN: penicillamine
Other descriptive name: penicillamine

gmp-orphan SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Brazil;Belgium;Denmark;Austria;Germany;United Kingdom;United States;France;Poland;Italy;Sweden