chufangao/CTO huggingface dataset:
Clinical trial NCT04311112: Safety and Efficacy of Zuretinol Acetate in Subjects With Inherited Retinal Disease
Official title: Safety and Efficacy of Zuretinol Acetate Oral Solution in Subjects With Inherited Retinal Disease Caused by Mutations in Retinal Pigment Epithelium Protein 65 or Lecithin:Retinol Acyltransferase
Sponsor: Retinagenix Holdings (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: The asset was transferred to another company
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-31
Primary completion date: 2023-02-28
Completion date: 2023-09-30
Plan to share individual participant data: NO
Clinical trial NCT05895123: Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
Official title: Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction
Sponsor: Damanhour University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-01
Primary completion date: 2023-03-01
Completion date: 2023-04-01
Plan to share individual participant data: NO
Clinical trial NCT04869397: Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells
Official title: Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase II Controlled Clinical Trial
Acronym: ProTrans19+
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: DSMB recommended to end the study prematurely as recruitment goals were not being met and benefit was not influencial enough.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-14
Primary completion date: 2023-05-26
Completion date: 2023-05-26
Clinical trial NCT02005471: A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Official title: A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab
Acronym: MURANO
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 389.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-03-17
Primary completion date: 2017-05-08
Completion date: 2022-08-03
Baseline population: Intent-to-treat (ITT) population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04063150: Immunogenicity of Intramuscular and Intradermal IPV
Official title: Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization
Acronym: IM and ID IPV
Sponsor: Centers for Disease Control and Prevention (FED)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: COVID-19 pandemic
Enrollment: 958.0 (ACTUAL)
Number of arms: 7.0
Start date: 2019-10-06
Primary completion date: 2020-03-25
Completion date: 2020-03-25
Plan to share individual participant data: NO
Clinical trial NCT04089852: Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women
Official title: Nitrous Oxide for Pain Management During Intrauterine Device Insertion in Nulliparous Adolescent Women
Sponsor: Boston Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Not able to perform intervention in current physical clinic location
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Plan to share individual participant data: NO
Clinical trial NCT02063685: Study to Evaluate the Efficacy of Response-adapted Strategy in Follicular Lymphoma
Official title: A Multicenter, Phase III, Randomized Study to Evaluate the Efficacy of Response-adapted Strategy to Define Maintenance After Standard Chemoimmunotherapy in Patients With Advanced-stage Follicular Lymphoma.
Sponsor: Fondazione Italiana Linfomi - ETS (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 807.0 (ACTUAL)
Number of arms: 4.0
Start date: 2012-07-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT04118075: PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT
Official title: Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
Sponsor: Shanghai Jiao Tong University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-01
Primary completion date: 2021-05-01
Completion date: 2021-05-01
Clinical trial NCT05173831: Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans
Official title: An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans
Acronym: MPG1
Sponsor: Lykos Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Transfer of Sponsorship
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-09-30
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Clinical trial NCT04458948: Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
Official title: Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection
Sponsor: University of New Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The World Health Organization (WHO) paused Hydrochloroquinone from its Solidarity Trial in order to conduct a safety data review by the Data Safety Monitoring Board of the WHO to evaluate HCQ in its clinical trials.
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-24
Primary completion date: 2020-08-28
Completion date: 2020-08-28
Baseline population: Our baseline population is from the state of New Mexico, Navajo nation and other surrounding Pueblo nations. We enrolled 28 patients, about equal males and females, ages from 32 to 85.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03521635: The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa
Official title: A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-03
Primary completion date: 2020-01-07
Completion date: 2020-01-07
Baseline population: Treated set (TS) was defined as all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
Limitations and caveats: According to the study results, the decision was made to stop transitioning to Stage II. Therefore, only results of Stage I were reported.
Clinical trial NCT03606655: Exploring the Impact of Two-week Kava on the Metabolism of Nicotine and NNK
Official title: A Single-Arm Pre- and Post-Pilot Trial Exploring the Impact of Two-week Kava on the Metabolism of Two Tobacco Chemicals, Nicotine and NNK, in Head and Neck Cancer Survivors Who Are Active Smokers
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Terms could not be met with the FDA.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2020-10-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
Clinical trial NCT04730297: Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery
Official title: Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery
Sponsor: University of Roma La Sapienza (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-01
Primary completion date: 2020-09-04
Completion date: 2020-10-14
Plan to share individual participant data: NO
Clinical trial NCT03782259: Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2
Official title: Effects of SGLT-2 Inhibition With Dapagliflozin on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI With T1- and T2-mapping in Patients With Type-2 Diabetes
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-26
Primary completion date: 2022-11-16
Completion date: 2022-11-16
Limitations and caveats: * Relatively small trial was not powered to detect small effect sizes.~* Animal studies of SGLT2 inhibition used direct pathologic examination of inflammation and fibrosis; Cardiac MRI is known to be less sensitive.~* 12-month treatment may not have been sufficient to detect meaningful changes in inflammation, fibrosis, and strain.~* No matched, non-diabetic control group.~* Higher ECV values (\>32) are associated with worse outcomes with known myocarditis.
Clinical trial NCT04538599: RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
Official title: RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
Sponsor: Zhejiang University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-10
Primary completion date: 2021-02-17
Completion date: 2021-11-30
Clinical trial NCT04509947: A Study of Ad26.COV2.S in Adults (COVID-19)
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults
Sponsor: Janssen Pharmaceutical K.K. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 250.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-11
Primary completion date: 2021-02-22
Completion date: 2021-11-16
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 NCT05451654: NanoMn®_COVID-19 A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
Official title: A Prospective, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blind Trial to Evaluate the Clinical Efficacy of NanoManganese® on Top of Standard of Care, in Adult Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
Sponsor: Medesis Pharma SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: the number of patients recruited was not reached because covid cases were low
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-04
Primary completion date: 2022-10-04
Completion date: 2022-12-01
Clinical trial NCT04992208: Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
Official title: Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study
Sponsor: Sinovac Biotech Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 31041.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-24
Primary completion date: 2023-03-24
Completion date: 2023-08-31
Clinical trial NCT03835481: A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
Official title: Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to company decision.
Enrollment: 165.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-03-18
Primary completion date: 2021-06-22
Completion date: 2021-07-27
Baseline population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial.
Limitations and caveats: The trial was ended prematurely by the sponsor. As a consequence, primary and secondary endpoints were limited to descriptive outcome measures. The recruitment was completed as planned.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT04233073: Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Official title: Prospective, Open-Label Clinical Study of Andexanet Alfa in Patients Receiving FXa (Activated Factor X) Inhibitor Who Require Urgent Surgery
Acronym: Annexa-S
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Limited value as a single-arm study
Enrollment: 10.0 (ACTUAL)
Start date: 2021-06-27
Primary completion date: 2021-11-23
Completion date: 2022-01-25
Baseline population: Safety Set: Participants who were enrolled into the study and treated with any amount of andexanet alfa. All data were prespecified to be collected as a single Arm/Group for any participant who received at least 1 dose of the study drug, regardless of their dose level.
Limitations and caveats: The study was terminated early due to the limited value as a single-arm study.
Plan to share individual participant data: YES
IPD sharing description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Clinical trial NCT04988308: A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
Official title: A Phase 2a/2b, Multicenter, Randomized, Placebo and Active Comparator-controlled, Double-Blind, Dose-ranging Study to Evaluate the Safety and Efficacy of Bermekimab (JNJ-77474462) for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa
Acronym: LYRA
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study has been prematurely terminated as the Interim Analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint.
Enrollment: 151.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-10-12
Primary completion date: 2022-10-14
Completion date: 2022-11-23
Limitations and caveats: As per change in planned analysis, Part 2 and some secondary efficacy analysis of Part 1 in this study was not conducted due to early termination because interim analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint. Hence, data for Part 2 and some secondary efficacy outcome measures (Parts 1 and 2) were not collected in this results summary.
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 NCT03915405: KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
Official title: An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Termination was based on the business decision
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-26
Primary completion date: 2022-11-15
Completion date: 2022-11-15
Clinical trial NCT04625543: Neoadjuvant Immunotherapy to ESCC
Official title: Neoadjuvant Immunotherapy Combined With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Cancer: an Open Label, Randomized Control, Phase II Trial
Sponsor: Qilu Hospital of Shandong University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: insufficient money
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2023-06-30
Completion date: 2023-09-30
Clinical trial NCT03522415: Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Sponsor: Shanghai Henlius Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 275.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-28
Primary completion date: 2020-04-05
Completion date: 2020-09-11
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03687476: Safety and Tolerability Study of VTS-270 in Pediatric Participants With Niemann-Pick Type C (NPC) Disease
Official title: An Open-label, Multicenter Safety and Tolerability Study of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Pediatric Subjects Aged < 4 Years With Neurologic Manifestations of Niemann-Pick Type C (NPC) Disease
Sponsor: Mallinckrodt (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Business decision to Cancel
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-31
Primary completion date: 2022-10-30
Completion date: 2022-10-30
Plan to share individual participant data: NO
Clinical trial NCT03525600: Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Sponsor: Apellis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 621.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-31
Primary completion date: 2021-06-21
Completion date: 2022-06-20
Baseline population: The Intent-to-treat (ITT) analysis set consisted of all subjects assigned to treatment.
Clinical trial NCT03930771: Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
Official title: Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
Acronym: TMZ-Cap
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: the study had a low accrual rate
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-21
Primary completion date: 2021-08-19
Completion date: 2021-10-01
Limitations and caveats: Due to lower accrual (N=1), there was insufficient data available in order to meet the primary and secondary outcome measures.
Plan to share individual participant data: NO
Clinical trial NCT03955458: EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture
Official title: A Phase-4, Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Fascia Iliaca Compartment Block Versus Fascia Iliaca Compartment Block With Continuous Infusion of Ropivacaine Per Standard of Care Through a Catheter in Intertrochanteric Hip Fracture Patients
Acronym: RESTORE
Sponsor: Pacira Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Recruitment difficulties
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-26
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Plan to share individual participant data: NO
Clinical trial NCT03809481: Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban
Official title: Open-Label, Randomised, Active Controlled, Multi-Centre Ph 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Acute HIT
Acronym: HITSOVA
Sponsor: Aspen Global Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Prolonged delay as a result of impact of Covid19 pandemic
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-16
Primary completion date: 2022-06-10
Completion date: 2022-06-10
Plan to share individual participant data: NO