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
210	単心室症	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	EUCTR2011-001187-21-DE (EUCTR)	28/11/2011	30/05/2011	Pilot study with children suffering from congenital heart defect who need a vascular surgery: Implantation of a living blood vessel that is produced in the laboratory from child's own body tissue.	A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow Tract. - SCRM-001 TEVG Study	functional single ventricle physiologyfunctional single left ventriclefunctional single right ventriclefunctional single biventricle MedDRA version: 14.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Autologous Tissue-Engineered Vascular Graft Product Code: SCRM001_TEVG	University of Zurich	NULL	Not Recruiting			Female: yes Male: yes		Phase 1;Phase 2	Germany

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

EUCTR2011-001187-21-DE
(EUCTR)

28/11/2011

30/05/2011

Pilot study with children suffering from congenital heart defect who need a vascular surgery: Implantation of a living blood vessel that is produced in the laboratory from child's own body tissue.

A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow Tract. - SCRM-001 TEVG Study

functional single ventricle physiologyfunctional single left ventriclefunctional single right ventriclefunctional single biventricle
MedDRA version: 14.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Autologous Tissue-Engineered Vascular Graft
Product Code: SCRM001_TEVG

University of Zurich

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Germany