chufangao/CTO huggingface dataset:
Clinical trial NCT04147416: A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation
Official title: A Multi-center, Open-label, Randomized, Propofol-controlled Study Evaluating the Efficacy and Safety of Intravenous Administration of HSK3486 Injectable Emulsion for Sedation in Intensive Care (ICU) Patients Undergoing Mechanical Ventilation
Sponsor: Haisco Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-22
Primary completion date: 2020-05-31
Completion date: 2020-07-03
Clinical trial NCT03425539: Efficacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With Fabry Disease
Official title: A Multicenter, dOuble-blind, ranDomized, Placebo-controlled, Parallel-group Study to Determine the effIcacy and Safety of Lucerastat Oral Monotherapy in Adult Subjects With FabrY Disease
Acronym: MODIFY
Sponsor: Idorsia Pharmaceuticals Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 118.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-21
Primary completion date: 2021-08-17
Completion date: 2021-09-02
Plan to share individual participant data: NO
Clinical trial NCT03302156: PSMA PET and MRI in Gynecological Cancers
Official title: PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual following suspension per COVID-19
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-11-15
Primary completion date: 2020-01-20
Completion date: 2020-01-20
Baseline population: study terminated early, no participants enrolled in dosimetry group
Limitations and caveats: Calculating accuracy, sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.
Clinical trial NCT04142788: RELieving Increasing oEdema Due to Heart Failure
Official title: A Phase IV, Registry-based, Randomised, Controlled, Open-label Trial Investigating the Potential for Patiromer-facilitated Use of Higher Doses of MRAs in Addition to Standard Care to Improve Congestion, Well-being, Morbidity and Mortality
Acronym: RELIEHF
Sponsor: NHS Greater Glasgow and Clyde (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was stopped due to low recruitment, which the Steering Committee and funder agreed could not be rectified.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-28
Primary completion date: 2022-12-20
Completion date: 2022-12-20
Clinical trial NCT02744742: G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Official title: Granulocyte Colony-stimulating Factor+Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor: Nanfang Hospital, Southern Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 202.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-18
Primary completion date: 2019-09-30
Completion date: 2021-09-30
Plan to share individual participant data: YES
Clinical trial NCT02374333: Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy
Official title: Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 Attached to TCRζ and 4-1BB Signaling Domains in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-03-25
Primary completion date: 2021-09-02
Completion date: 2021-09-02
Clinical trial NCT04950751: Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults
Official title: An Observer-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults
Sponsor: Clover Biopharmaceuticals AUS Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: sponsor decided to withdrawn the study as development strategy has changed
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-08-31
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Clinical trial NCT04866056: Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
Official title: A Multicentric Phase I/II Study of Jaktinib Hydrochloride Tablets in Combination With Azacitidine for Injection in Patients With Myelodysplastic Syndromes(MDS) With Myelofibrosis(MF) or MDS/Myeloproliferative Neoplasms With MF
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Corporate policy adjustments
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-30
Primary completion date: 2022-06-10
Completion date: 2022-06-10
Clinical trial NCT03636451: Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o
Official title: Assessing the Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage: a Randomized Controlled Trial
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 114.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-29
Primary completion date: 2020-12-14
Completion date: 2022-09-27
Limitations and caveats: Limitations of our study include a lack of variation in the clinical setting for which the dilation and aspiration procedures were performed (outpatient clinics at large academic centers) limiting the generalizability of the study to community care settings. The study was powered to evaluate only a 20-mm difference in pain control within each stratum of the cohort. Larger sample sizes in each stratum could potentially detect a more subtle effect on pain control.
Plan to share individual participant data: NO
Clinical trial NCT01107626: Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Official title: Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Sponsor: Eastern Cooperative Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1516.0 (ACTUAL)
Number of arms: 3.0
Start date: 2010-10-25
Primary completion date: 2019-01-31
Completion date: 2021-08-17
Baseline population: All registered patients
Plan to share individual participant data: YES
IPD sharing description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Clinical trial NCT02004613: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Official title: Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Acronym: Decade
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 798.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-06-30
Primary completion date: 2018-12-31
Completion date: 2020-12-18
Clinical trial NCT04044664: Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Official title: A Study to Evaluate the Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Sponsor: Aptinyx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 160.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-25
Primary completion date: 2020-08-05
Completion date: 2020-08-05
Clinical trial NCT03538054: Dextromethorphan in Fibromyalgia
Official title: Dextromethorphan in Fibromyalgia
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-26
Primary completion date: 2020-03-18
Completion date: 2020-03-18
Limitations and caveats: Medication was tested in a small number of fibromyalgia (FM) patients, limiting generalizability. Length of DXM treatment was only 10 weeks, so it is unclear if the results are durable. We used a single-blind design that could have led to experimenter bias. We relied only on self-reported pain rather than using objective pain assessments.
Plan to share individual participant data: NO
Clinical trial NCT03568162: Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
Sponsor: Ichnos Sciences SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 462.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-05-31
Primary completion date: 2020-08-11
Completion date: 2021-08-03
Baseline population: Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study medication. Participants were analyzed according to the treatment group assigned. Two participants randomized to ISB 830 300 mg q4w group discontinued study without receiving any study drug and were excluded from FAS.
Clinical trial NCT03982199: A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Acronym: CYPRESS
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated early by the sponsor due to strategic reprioritization reasons.
Enrollment: 5815.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-01
Primary completion date: 2022-06-06
Completion date: 2023-05-26
Baseline population: The Full Analysis Set (FAS) included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04570475: High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache
Official title: High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache: a Randomized, Double-blind, Placebo Controlled Trial.
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low number met criteria to randomize.
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-15
Primary completion date: 2024-05-13
Completion date: 2024-05-13
Plan to share individual participant data: NO
Clinical trial NCT03357224: PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL)
Official title: Phase II Trial of Atezolizumab (Anti-PD-L1) in the Treatment of Stage IIb-IV Mycosis Fungoides/Sezary Syndrome Patients Relapsed/Refractory After a Previous Systemic Treatment
Acronym: PARCT
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Following an urgent safety measure due to toxicity recruitment has been closed prematurely.
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-24
Primary completion date: 2021-03-11
Completion date: 2022-08-18
Clinical trial NCT03518203: Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients
Official title: Early Intervention With Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome (TMA/aHUS)-Associated Multiple Organ Dysfunction Syndrome (MODS) in Hematopoietic Stem Cell Transplant (HCT) Recipients
Sponsor: Children's Hospital Medical Center, Cincinnati (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-03
Primary completion date: 2022-04-04
Completion date: 2022-06-01
Clinical trial NCT02620865: BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
Official title: Phase Ib/II Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs) in Combination With Low Dose IL-2 and GM-CSF
Sponsor: Barbara Ann Karmanos Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-12-31
Primary completion date: 2021-06-21
Completion date: 2021-06-21
Clinical trial NCT04029038: Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma
Official title: Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: 0 participant accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-15
Primary completion date: 2022-11-16
Completion date: 2022-11-16
Clinical trial NCT03862170: Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer
Official title: Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer: a Phase III Randomized Trial
Acronym: BRP30
Sponsor: CR-CSSS Champlain-Charles-Le Moyne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Covid-19 pandemic
Enrollment: 255.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2015-02-10
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Plan to share individual participant data: NO
Clinical trial NCT02265731: Study Evaluating Venetoclax in Subjects With Hematological Malignancies
Official title: A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-09-22
Primary completion date: 2021-03-12
Completion date: 2021-03-12
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03755440: PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.
Official title: Phase II Study of PD-1 Antibody SHR-1210 in EBV Positive Metastatic Gastric Cancer Patients.
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-01
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04102449: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Official title: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Acronym: PSA-ULTRA
Sponsor: Medical University of Graz (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Funding stopped
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-01
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Clinical trial NCT04088188: Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma
Official title: A Phase I, Multi-Center, Open Label, Dose De-Escalation and Expansion Study of Gemcitabine and Cisplatin With AG120 or Pemigatinib for Advanced Cholangiocarcinoma
Sponsor: Academic and Community Cancer Research United (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-25
Primary completion date: 2023-12-01
Completion date: 2023-12-01
Baseline population: Arms A and B are reported together to maintain patient deidentification and privacy.
Clinical trial NCT05043987: Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers
Official title: A Phase 1, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate Safety of CPO102, an Anti-claudin 18.2 Antibody-MMAE Drug Conjugate Administered Intravenously in Patients With Advanced Pancreatic and Gastric Cancers
Sponsor: Conjupro Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: New IND sponsor to initiate a separate study
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-11-16
Primary completion date: 2022-11-16
Completion date: 2022-11-16
Plan to share individual participant data: NO
IPD sharing description: Undecided
Clinical trial NCT04258410: Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency
Official title: Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency (QUICKENED) Feasibility Study in Older Women
Acronym: QUICKENED
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Per PI: Never went to IRB Never recruited anyone Never resubmitted the score NIH application I am leaving the institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-30
Primary completion date: 2023-12-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT03686813: Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention
Official title: Sildenafil for Prevention of Swimming-Induced Pulmonary Edema (SIPE)
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-15
Primary completion date: 2021-10-29
Completion date: 2021-10-29
Plan to share individual participant data: UNDECIDED
IPD sharing description: Data will be published in the open literature
Clinical trial NCT04605588: A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
Official title: A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo
Acronym: TriACT
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of participants willing to enroll
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-02
Primary completion date: 2021-01-17
Completion date: 2021-02-04
Clinical trial NCT05076656: Epigenetic and Microbiota Modifications
Official title: Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
Acronym: EPI-MICROBIO
Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-10
Primary completion date: 2020-10-17
Completion date: 2022-06-30
Clinical trial NCT03386929: Survival Prolongation by Rationale Innovative Genomics
Official title: A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination
Acronym: SPRING
Sponsor: Worldwide Innovative Network Association (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-29
Primary completion date: 2022-12-29
Completion date: 2022-12-29
Limitations and caveats: The trial was early terminated after the end of its Phase 1 due to lack of funding. As a result it was not possible to analyse the objectives of the study.
Plan to share individual participant data: NO
Clinical trial NCT02013037: The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
Official title: The De-novo Use of Eculizumab Alongside Conventional Therapy in Presensitized Patients Receiving Cardiac Transplantation: An Open-Label, Investigator-Initiated Pilot Trial: [The DUET Cardiac Trial]
Acronym: DUET
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-11-30
Primary completion date: 2019-12-30
Completion date: 2020-04-30
Baseline population: The trial enrolled a total of 36 sensitized participants age ≥ 18 years with a panel reactive antibody (PRA) ≥70% at any time prior to study screening. Participants were included in the eculizumab treatment group if at least one DSA at MFI≥ 5000 was crossed but with negative prospective complement-dependent cytotoxicity (CDC) crossmatch. The eculizumab group consisted of 20 consecutive recipients transplanted between June 2, 2013 and July 31, 2018.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that supports the results of the study after deidentification and in accordance with Cedars Sinai data sharing agreements.
IPD time frame: Data will be available following publication and ending 3 years following article publication.
IPD access criteria: Data will be available to investigators whose proposed used of the data has been approved by Cedars Sinai IRB.