Antithymocyte Globulin ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
60再生不良性貧血28
284ダイアモンド・ブラックファン貧血2

60. 再生不良性貧血


臨床試験数 : 245 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05323617
(ClinicalTrials.gov)
May 15, 20235/4/2022Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive TherapyTwo Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Adult Severe Aplastic Anemia Participants Who Are Either Previously Untreated With IST or Refractory to ISTSevere Aplastic Anemia (SAA)Drug: Romiplostim;Drug: Antithymocyte Globulin;Drug: Cyclosporine AAmgenNULLNot yet recruiting18 YearsN/AAll40Phase 2NULL
2NCT05049668
(ClinicalTrials.gov)
October 202113/9/2021RACE 2: a Long Term Follow-up of Patients Participating in the RACE TrialLong-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia PatientsSevere Aplastic AnemiaDrug: ATGAM plus CsA with or without EltrombopagEuropean Society for Blood and Marrow TransplantationNULLEnrolling by invitationN/AN/AAll197France
3NCT03531736
(ClinicalTrials.gov)
May 9, 20189/5/2018T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic AnemiaAllogeneic Hematopoietic Stem Cell Transplantation of a/ß T-Lymphocyte Depleted Graft Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic AnemiaMyeloid DiseasesDrug: Antithymocyte globulin (Rabbit);Drug: fludarabine;Radiation: total body irradiation;Drug: cyclophosphamide;Drug: Rituxan;Procedure: Allogeneic Hematopoietic Stem Cell TransplantationMemorial Sloan Kettering Cancer CenterNULLRecruiting18 YearsN/AAll15Phase 1United States
4NCT03318159
(ClinicalTrials.gov)
April 20, 201810/10/2017Posaconazole Prophylaxis During ATG Treatment for hMDS/AA PatientsOpen Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin TreatmentAplastic Anemia;Myelodysplastic Syndromes;Fungal InfectionDrug: PosaconazoleSeoul National University HospitalMerck Sharp & Dohme Corp.Unknown status18 Years75 YearsAll40Phase 2Korea, Republic of
5NCT02918292
(ClinicalTrials.gov)
July 3, 201727/9/2016Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)Severe Aplastic AnemiaDrug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSFMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor ProgramCompletedN/A75 YearsAll32Phase 2United States
6EUCTR2014-000363-40-NL
(EUCTR)
07/01/201601/09/2015A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function.A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia.
MedDRA version: 19.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
INN or Proposed INN: ELTROMBOPAG
European Society for Blood and Marrow TransplantationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Spain;Netherlands
7EUCTR2014-000363-40-ES
(EUCTR)
26/10/201507/09/2015A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function.A prospective Randomized multicenter study comparing horse Antithymocyte globuline (hATG) + Cyclosporine A (CsA) with or without Eltrombopag as front-line therapy for severe aplastic anemia patients. - RACE Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia.
MedDRA version: 18.0;Level: PT;Classification code 10002967;Term: Aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Revolade
INN or Proposed INN: ELTROMBOPAG
European Society for Blood and Marrow TransplantationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Spain
8NCT02099747
(ClinicalTrials.gov)
July 20156/3/2014hATG+CsA vs hATG+CsA+Eltrombopag for SAAA Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients.Severe Aplastic AnemiaDrug: hATG;Drug: CsA;Drug: EltrombopagEuropean Group for Blood and Marrow TransplantationNovartis;PfizerActive, not recruiting15 YearsN/AAll202Phase 3France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany
9NCT01844635
(ClinicalTrials.gov)
May 201229/4/2013Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAAA Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic AnemiaAcquired Aplastic Anemia.Drug: ThymoglobulinNagoya UniversityNULLRecruitingN/A69 YearsBoth320Phase 3Japan
10EUCTR2007-000902-55-DE
(EUCTR)
17/12/200929/09/2009Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working PartyProspective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 12.0;Level: LLT;Classification code 10002969;Term: Aplastic anemia
Trade Name: Thymoglobulin
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
EBMT (European Group for Blood and Marrow Transplantation)NULLNot RecruitingFemale: yes
Male: yes
35Phase 2France;Germany;United Kingdom
11NCT01105273
(ClinicalTrials.gov)
July 20098/4/2010Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic AnemiaHLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte GlobulinAplastic AnemiaBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: Fludarabine;Drug: Cyclophosphamide;Procedure: CD3±CD19 depleted hematopoietic stem cell transplantationAsan Medical CenterNULLCompletedN/A21 YearsBoth12Phase 1/Phase 2Korea, Republic of
12EUCTR2009-012746-23-IT
(EUCTR)
12/05/200924/06/2009pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - NDpilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND acquired aplastic anemia
MedDRA version: 9.1;Level: SOC;Classification code 10005329
Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML
INN or Proposed INN: Etanercept
ISTITUTO GIANNINA GASLININULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
13NCT00882323
(ClinicalTrials.gov)
November 200815/4/2009Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic AnemiaAplastic AnemiaDrug: Cyclophosphamide, Fludarabine, ThymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLRecruiting1 Year21 YearsBoth33Phase 2Korea, Republic of
14NCT00471848
(ClinicalTrials.gov)
August 20089/5/2007Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic AnaemiaProspective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia and Comparison With Matched Historical Patients Treated With Horse ATG and CiclosporinAplastic AnemiaDrug: rabbit antithymocyte globulinEuropean Group for Blood and Marrow TransplantationGenzyme, a Sanofi CompanyActive, not recruiting16 YearsN/ABoth35Phase 2France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom
15EUCTR2007-000902-55-FR
(EUCTR)
23/04/200804/10/2007Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and CiclosporinProspective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin Aquired aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 9.1;Level: LLT;Classification code 10002274;Term: Anemia aplastic
Trade Name: Thymoglobuline
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
Other descriptive name: GLYCINE
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: Mannitol
Trade Name: Neoral
Product Name: Ciclosporine
INN or Proposed INN: Cyclosporin A
Other descriptive name: Ciclosporine
EBMT (European group for Blood and Marrow Transplantation)NULLNot RecruitingFemale: yes
Male: yes
35Phase 2France;Germany;United Kingdom
16NCT01530555
(ClinicalTrials.gov)
April 200824/1/2012Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaProspective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaAcquired Aplastic AnaemiaDrug: Rabbit ATG, Thymoglobuline (Genzyme)King Faisal Specialist Hospital & Research CenterNULLCompleted16 Years80 YearsBoth35Phase 2NULL
17EUCTR2007-000902-55-GB
(EUCTR)
19/09/200726/06/2007Prospective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and CiclosporinProspective Phase II study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 14.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: Thymoglobuline
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
INN or Proposed INN: GLYCINE
INN or Proposed INN: Sodium chloride
INN or Proposed INN: Mannitol
EBMT (European group for Blood and Marrow Transplantation)NULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Germany;United Kingdom
18NCT00455312
(ClinicalTrials.gov)
August 200730/3/2007Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAAHematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: MethylprednisoloneMasonic Cancer Center, University of MinnesotaNULLCompletedN/A70 YearsAll36Phase 2/Phase 3United States
19NCT00474747
(ClinicalTrials.gov)
February 7, 200616/5/2007Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation in Aplastic AnemiaFludarabine-Based Conditioning for Allogeneic Marrow Transplantation From HLA-Compatible Unrelated Donors in Severe Aplastic AnemiaAplastic AnemiaDrug: Antithymocyte Globulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body Irradiation (TBI);Procedure: Bone Marrow TransplantM.D. Anderson Cancer CenterNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI)CompletedN/A65 YearsAll5Phase 1/Phase 2United States
20NCT00354419
(ClinicalTrials.gov)
February 200619/7/2006Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood TransplantA Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord BloodAplastic AnemiaRadiation: total-body irradiation;Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: umbilical cord blood transplantation;Drug: mycophenolate mofetil;Procedure: bone marrow aspiration;Genetic: DNA analysis;Biological: filgrastimFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)TerminatedN/A40 YearsBoth30Phase 1United States
21NCT00343785
(ClinicalTrials.gov)
February 200622/6/2006Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow TransplantCyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center TrialAplastic AnemiaDrug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: allogeneic bone marrow transplantation;Drug: methotrexate;Genetic: DNA analysis;Other: flow cytometry;Genetic: polymorphism analysis;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedN/A65 YearsAll21Phase 2United States;Canada
22NCT01231841
(ClinicalTrials.gov)
March 200529/10/2010Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic AnemiaProtocol for Prospective Phase II Study of Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) as a First Line Immunosuppressive (IS) Therapy for Severe Aplastic Anemia (sAA)Aplastic AnemiaDrug: cyclosporine;Biological: anti-thymocyte globulinThe Cleveland ClinicNULLCompleted12 YearsN/AAll20Phase 2United States
23NCT00065260
(ClinicalTrials.gov)
July 200318/7/2003Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic AnemiaA Randomized Trial of Immunosuppression in Aplastic Anemia Patients With Refractory Pancytopenia or Suboptimal Hematologic Response After h-ATG/CsA TreatmentAplastic AnemiaDrug: Campath-1H;Drug: r-ATG;Drug: CsANational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll54Phase 2United States
24NCT01163942
(ClinicalTrials.gov)
March 200114/7/2010Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSFAplastic AnaemiaDrug: G-CSF;Drug: Early retreatment with ATGEuropean Group for Blood and Marrow TransplantationCHUGAI sanofi-aventisTerminatedN/AN/ABoth205Phase 3Czech Republic;France;Germany;Greece;Italy;Netherlands;Sweden;Switzerland;United Kingdom
25NCT00427336
(ClinicalTrials.gov)
December 200025/1/2007Purine Analog-Based Conditioning in Patients With Severe Aplastic AnemiaPurine Analog-Based Conditioning for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaAplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Antithymocyte GlobulinM.D. Anderson Cancer CenterNULLCompletedN/A70 YearsAll9N/AUnited States
26NCT00001964
(ClinicalTrials.gov)
March 17, 200018/1/2000Combination Therapy of Severe Aplastic AnemiaTreatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF)Severe Aplastic AnemiaDrug: Cyclosporine A;Drug: ATG;Drug: MMFNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted1 Year99 YearsAll104Phase 2United States
27NCT00004474
(ClinicalTrials.gov)
September 199818/10/1999Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic AnemiaPhase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic AnemiaAplastic AnemiaDrug: Anti-thymocyte globulin;Drug: Cyclophosphamide;Procedure: Bone marrow transplantationRoswell Park Cancer InstituteNULLCompletedN/A59 YearsAll224Phase 3United States
28NCT00001626
(ClinicalTrials.gov)
June 2, 19973/11/1999Comparing Therapies for the Treatment of Severe Aplastic AnemiaA Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: antithymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted15 Years110 YearsAll33Phase 2United States

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00305708
(ClinicalTrials.gov)
August 200021/3/2006Busulfan, Antithymocyte Globulin, and Fludarabine Followed By a Donor Stem Cell Transplant in Treating Young Patients With Blood Disorders, Bone Marrow Disorders, Chronic Myelogenous Leukemia in First Chronic Phase, or Acute Myeloid Leukemia in First RemissionBone Marrow Stem Cell Transplantation for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myeloid Leukemia in 1RemissionCongenital Amegakaryocytic Thrombocytopenia;Diamond-blackfan Anemia;Fanconi Anemia;Leukemia;Severe Congenital Neutropenia;ThrombocytopeniaBiological: anti-thymocyte globulin;Drug: busulfan;Drug: fludarabine phosphate;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantation;Radiation: radiation therapyUniversity of California, San FranciscoNational Cancer Institute (NCI)CompletedN/A17 YearsBoth40Phase 1/Phase 2United States
2NCT00001749
(ClinicalTrials.gov)
July 19983/11/1999Medical Treatment for Diamond Blackfan AnemiaTreatment of Diamond Blackfan Anemia With Antithymocyte Globulin and Cyclosporine AFanconi's Anemia;Hematologic DiseaseDrug: Antithymocyte globulin;Drug: CyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth25Phase 2United States