211. 左心低形成症候群 Hypoplastic left heart syndrome Clinical trials / Disease details
臨床試験数 : 22 / 薬物数 : 29 - (DrugBank : 9) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 14
| 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 | NCT04925024 (ClinicalTrials.gov) | June 25, 2021 | 8/6/2021 | Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. | Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. | Hypoplastic Left Heart Syndrome | Biological: Lomecel-B medicinal signaling cells | Ann & Robert H Lurie Children's Hospital of Chicago | National Heart, Lung, and Blood Institute (NHLBI);The University of Texas Health Science Center, Houston;Longeveron Inc. | Recruiting | N/A | 12 Months | All | 38 | Phase 2 | United States |
| 2 | NCT04181255 (ClinicalTrials.gov) | February 25, 2020 | 26/11/2019 | Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy | The Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy Following Deep Hypothermic Circulatory Arrest During Cardiac Surgery | Congenital Heart Disease;Hypoplastic Left Heart Syndrome | Drug: Curosurf;Drug: Sham | University of Michigan | Chiesi Farmaceutici S.p.A. | Recruiting | N/A | 12 Weeks | All | 60 | Phase 1 | United States |
| 3 | NCT04090697 (ClinicalTrials.gov) | December 20, 2019 | 4/4/2019 | Use of Oxandrolone to Promote Growth in Infants With HLHS | Use of Oxandrolone to Promote Growth in Infants With Hypoplastic Left Heart Syndrome: A Phase I/II Pilot Study | Hypoplastic Left Heart;Congenital Heart Disease | Drug: Oxandrolone | HealthCore-NERI | NULL | Recruiting | N/A | 14 Days | All | 100 | Phase 1/Phase 2 | United States;Canada |
| 4 | NCT03406884 (ClinicalTrials.gov) | October 16, 2019 | 20/12/2017 | The CHILD Trial: Hypoplastic Left Heart Syndrome Study. | Autologous Cardiac Stem Cell Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study. | Hypoplastic Left Heart Syndrome | Biological: c-kit+ cells | University of Miami | NULL | Recruiting | 1 Day | 21 Days | All | 32 | Phase 1 | United States |
| 5 | NCT03779711 (ClinicalTrials.gov) | June 6, 2019 | 4/12/2018 | Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome | Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2) | Hypoplastic Left Heart Syndrome | Biological: Autologous (self) mononuclear cells derived from umbilical cord blood;Procedure: Stage II Surgical repair | Timothy J Nelson, MD, PhD | University of Oklahoma;Children's Hospital of Philadelphia;Children's Hospital Los Angeles;Children's Hospital Colorado;Children's Hospitals and Clinics of Minnesota;Ochsner Health System;Children's of Alabama;Children's Hospital Medical Center, Cincinnati | Active, not recruiting | N/A | 12 Months | All | 95 | Phase 2 | United States |
| 6 | NCT03525418 (ClinicalTrials.gov) | February 21, 2018 | 19/2/2018 | Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) | Lomecel-B Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase I/II Study (ELPIS) | HLHS | Biological: Longeveron Mesenchymal Stem Cells | Longeveron Inc. | NULL | Completed | N/A | 1 Year | All | 10 | Phase 1/Phase 2 | United States |
| 7 | NCT03136835 (ClinicalTrials.gov) | February 2, 2018 | 28/10/2015 | Maternal Hyperoxygenation in Congenital Heart Disease | Maternal Hyperoxygenation in Congenital Heart Disease | Hypoplastic Left Heart Syndrome | Drug: Maternal Hyperoxygenation | The Hospital for Sick Children | NULL | Recruiting | 18 Years | N/A | Female | 20 | Phase 1/Phase 2 | Canada |
| 8 | NCT03079401 (ClinicalTrials.gov) | November 27, 2017 | 8/3/2017 | Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle | Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle | Hypoplastic Left Heart Syndrome;Atrioventricular Canal | Biological: MPC; rexlemestrocel-L | Boston Children's Hospital | NULL | Active, not recruiting | N/A | 5 Years | All | 19 | Phase 1/Phase 2 | United States |
| 9 | NCT02781922 (ClinicalTrials.gov) | June 2016 | 19/5/2016 | Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial) | Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study | Hypoplastic Left Heart Syndrome;Single Ventricle | Genetic: Autologous cardiac stem cells (JRM-001) | Metcela Inc. | NULL | Recruiting | 0 Years | 6 Years | All | 40 | Phase 3 | Japan |
| 10 | NCT03147014 (ClinicalTrials.gov) | January 1, 2016 | 4/5/2017 | Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease | Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease | Hypoplastic Left Heart Syndrome;Aortic Coarctation;Atrial Septal Aneurysm | Biological: Maternal hyperoxygenation | Beijing Anzhen Hospital | NULL | Recruiting | N/A | N/A | Female | 600 | N/A | China |
| 11 | NCT02080637 (ClinicalTrials.gov) | July 2015 | 21/2/2014 | Ambrisentan in Single Ventricle | Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients | Hypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart Complex | Drug: Ambrisentan;Other: Placebo | Kevin Hill | NULL | Completed | 24 Months | 120 Months | All | 16 | Phase 2 | United States |
| 12 | JPRN-UMIN000017311 | 2015/05/01 | 01/05/2015 | Hypoxia inhalation therapy for infants with pulmonary congestion caused by congenital heart disease. | Hypoxia inhalation therapy for infants with pulmonary congestion caused by congenital heart disease. - Hypoxia inhalation therapy for infants | hypoplastic left heart syndrome, coarctation of aorta, interruption of aorta, truncus arteriosus, double outlet of right ventricle (Taussig-Bing anomaly), single ventricles | Hypoxia inhalation nitrogen inhalation | Institutional Review Board of Kagoshima University | NULL | Pending | 1days-old | 365days-old | Male and Female | 30 | Not selected | Japan |
| 13 | NCT02398604 (ClinicalTrials.gov) | April 2015 | 24/12/2014 | Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome | Allogeneic Human MEsenchymal Stem Cell (hMSC) Injection in Patients With Hypoplastic Left Heart Syndrome: An Open Label Pilot Study. | Hypoplastic Left Heart Syndrome | Drug: Allo-hMSCs;Drug: Placebo | Longeveron Inc. | NULL | Terminated | N/A | 30 Days | All | 5 | Phase 1 | United States |
| 14 | NCT01883076 (ClinicalTrials.gov) | May 15, 2013 | 11/6/2013 | Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome | Phase I Safety Study of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Stage II Palliation of Hypoplastic Left Heart Syndrome | Hypoplastic Left Heart Syndrome | Biological: autologous cell-based delivery | Timothy J Nelson, MD, PhD | University of Oklahoma;Children's Hospital of Philadelphia;Children's Hospitals and Clinics of Minnesota;Children's Hospital Los Angeles;Children's Hospital Colorado;Mayo Clinic | Completed | N/A | 18 Months | All | 30 | Phase 1 | United States |
| 15 | NCT01829750 (ClinicalTrials.gov) | April 2013 | 9/4/2013 | Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS) | Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease | Hypoplastic Left Heart Syndrome;Single Right Ventricle;Single Left Ventricle | Genetic: Cardiac progenitor cell infusion | Okayama University | Translational Research Informatics Center, Kobe, Hyogo, Japan | Completed | N/A | 20 Years | All | 34 | Phase 2 | Japan |
| 16 | NCT01445041 (ClinicalTrials.gov) | September 1, 2011 | 15/9/2011 | Safety and Feasibility Study of Umbilical Cord Blood Cells for Infants With Hypoplastic Left Heart Syndrome | Autologous Cord Blood Cells for Patients With HLHS: Phase I Study of Feasibility and Safety | Hypoplastic Left Heart Syndrome | Biological: Autologous Umbilical Cord Blood | Michael Cotten | NULL | Terminated | N/A | 2 Days | All | 7 | Phase 1 | United States |
| 17 | NCT01292551 (ClinicalTrials.gov) | February 2011 | 8/2/2011 | Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. | Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test | Hypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of Heart | Drug: Bosentan;Drug: Placebo | Rigshospitalet, Denmark | Aarhus University Hospital;Bispebjerg Hospital;Actelion | Completed | 15 Years | N/A | Both | 75 | Phase 2 | Denmark;Sweden |
| 18 | EUCTR2010-022389-28-DK (EUCTR) | 12/11/2010 | 26/10/2010 | Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test.[TEMPO-study]. | Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test.[TEMPO-study]. | Patients with a univentricular heart, who have recieved paliating surgery in the form of TCPC operation MedDRA version: 14.1;Level: PT;Classification code 10021076;Term: Hypoplastic left heart syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Tracleer | Lars Søndergaard | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 19 | NCT00974025 (ClinicalTrials.gov) | June 2009 | 9/9/2009 | Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients | Vitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan Palliation | Fontan Procedure;Hypoplastic Left Heart Syndrome;Tricuspid Atresia | Dietary Supplement: Vitamin C;Dietary Supplement: Placebo | University of Michigan | Griese-Hutchinson Champions for Children's Hearts Investigator Award | Completed | 8 Years | 25 Years | All | 53 | N/A | United States |
| 20 | EUCTR2008-007413-76-FI (EUCTR) | 27/02/2009 | 23/12/2008 | Metyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessä | Metyyliprednisolonin farmakokinetiikka ja -dynamiikka lasten avosydänleikkausten yhteydessä | Lasten ja nuorten sairaalassa (HUS) hoidettavat 1-12 kk ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikanan TOF, AVSD tai VSD.Lasten ja nuorten sairaalassa (HUS) hoidettavat korkeintaan 28 päivän ikäiset avosydänleikkaukseen tulevat potilaat, joilla on sydänvikana TGA, HLHS tai IAA. MedDRA version: 9.1;Level: LLT;Classification code 10010495;Term: Congenital heart disease NOS | Trade Name: Solu-Medrol INN or Proposed INN: metyyliprednisoloninatriumsuksinaatti Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Pertti Suominen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Finland | |||
| 21 | NCT00507819 (ClinicalTrials.gov) | December 2007 | 25/7/2007 | Sildenafil After the Fontan Operation | The Sildenafil After Fontan Operation Study | Hypoplastic Left Heart Syndrome;Tricuspid Atresia | Drug: Sildenafil;Drug: Placebo | Children's Hospital of Philadelphia | The Mark H. and Blanche M. Harrington Foundation | Completed | 8 Years | 40 Years | All | 28 | Phase 2 | United States |
| 22 | NCT00513240 (ClinicalTrials.gov) | September 2006 | 7/8/2007 | Erythropoetin Neuroprotection for Neonatal Cardiac Surgery | Erythropoetin Neuroprotection for Neonatal Cardiac Surgery | Congenital Heart Disease;Hypoplastic Left Heart Syndrome;Transposition of the Great Arteries;Aortic Arch Hypoplasia or Interruption | Drug: Erythropoetin;Drug: Normal saline | Baylor College of Medicine | The Dana Foundation;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | N/A | 30 Days | All | 62 | Phase 1/Phase 2 | United States |