DDrare: Database of Drug Development for Rare Diseases

Searched query = "Single Ventricle", "SV", "Single ventricle heart defect", "Univentricular heart", "UVH", "Single ventricular circulation 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.

Drug = ACETYLSALICYLIC ACID; ACT-064992; Acetylsalicylic acid; Administration of an ACE-inhibitor or not; Aesculus Hippocastanum / Horse Chestnut; Ambrisentan; Arginine; Aspirin; Autologous Tissue-Engineered Vascular Graft; BAY 59-7939; Bosentan; Carvedilol; Colchicine; Digoxin; Enalapril; Eplerenone; Horse chestnut; JNJ-39039039; Liothyronine; Liothyronine I 131; MACITENTAN; MPC; MZ101; Macitentan; Milk; Mysildecard; Mysildecard 20 mg; Nitric Oxide; Normal Saline; ODSH at 0.125 mg/kg/h; ODSH at 0.250 mg/kg/h; ODSH at 0.375 mg/kg/h; Opsumit; Opsumit®; Other: Human Milk Derived Fortifier; Other: Human/Bovine Milk; RIVAROXABAN; Rexlemestrocel-L; Rivaroxaban; SCRM001_TEVG; Sildenafil; Sildenafil by injection; Spironolactone; Spironolactone (drug); Sugar pill; Tadalafil; Tadalafil Citrate; Tracleer; Treprostinil; Udenafil; Vasopressin; Vasopressin, Arginine; Vitamin C; Xarelto

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	NCT03430583 (ClinicalTrials.gov)	February 20, 2018	22/1/2018	Evaluation of Fontan-Associated Liver Disease	Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study	Single Ventricle Heart Disease	Drug: MZ101	Mezzion Pharma Co. Ltd	National Heart, Lung, and Blood Institute (NHLBI)	Active, not recruiting	12 Years	N/A	All	100		United States;Canada
2	NCT03013751 (ClinicalTrials.gov)	January 2017	5/1/2017	A Extension Study of Udenafil in Adolescents	A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation	Functional Single Ventricle Heart Disease	Drug: Udenafil	Mezzion Pharma Co. Ltd	National Heart, Lung, and Blood Institute (NHLBI)	Active, not recruiting	12 Years	18 Years	All	300	Phase 3	United States;Canada;Korea, Republic of
3	NCT02741115 (ClinicalTrials.gov)	July 22, 2016	10/4/2016	Fontan Udenafil Exercise Longitudinal Assessment Trial	Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)	Single Ventricle Heart Disease	Drug: Udenafil;Drug: Placebo	Mezzion Pharma Co. Ltd	National Heart, Lung, and Blood Institute (NHLBI)	Completed	12 Years	18 Years	All	400	Phase 3	United States;Canada;Korea, Republic of
4	NCT02201342 (ClinicalTrials.gov)	July 2014	24/7/2014	Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents	A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation	Single Ventricle Heart Disease After Fontan Surgery	Drug: Udenafil	Mezzion Pharma Co. Ltd	National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network;National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network	Completed	14 Years	18 Years	Both	36	Phase 1;Phase 2	United States;Canada

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

NCT03430583
(ClinicalTrials.gov)

February 20, 2018

22/1/2018

Evaluation of Fontan-Associated Liver Disease

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

Single Ventricle Heart Disease

Drug: MZ101

Mezzion Pharma Co. Ltd

National Heart, Lung, and Blood Institute (NHLBI)

Active, not recruiting

12 Years

N/A

All

100

United States;Canada

NCT03013751
(ClinicalTrials.gov)

January 2017

5/1/2017

A Extension Study of Udenafil in Adolescents

A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

Functional Single Ventricle Heart Disease

Drug: Udenafil

Mezzion Pharma Co. Ltd

National Heart, Lung, and Blood Institute (NHLBI)

Active, not recruiting

12 Years

18 Years

All

300

Phase 3

United States;Canada;Korea, Republic of

NCT02741115
(ClinicalTrials.gov)

July 22, 2016

10/4/2016

Fontan Udenafil Exercise Longitudinal Assessment Trial

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

Single Ventricle Heart Disease

Drug: Udenafil;Drug: Placebo

Mezzion Pharma Co. Ltd

National Heart, Lung, and Blood Institute (NHLBI)

Completed

12 Years

18 Years

All

400

Phase 3

United States;Canada;Korea, Republic of

NCT02201342
(ClinicalTrials.gov)

July 2014

24/7/2014

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

Single Ventricle Heart Disease After Fontan Surgery

Drug: Udenafil

Mezzion Pharma Co. Ltd

National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network;National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network

Completed

14 Years

18 Years

Both

Phase 1;Phase 2

United States;Canada