chufangao/CTO huggingface dataset:
Clinical trial NCT04094662: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 393.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-18
Primary completion date: 2022-01-17
Completion date: 2022-01-24
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT05222516: Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD
Official title: A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa Trial to Investigate the Efficacy of OM-85 Versus Matched Placebo in Reducing Disease Severity Children Aged 3 to 24 Months With Early Clinical Diagnosis of Moderate Atopic Dermatitis
Sponsor: OM Pharma SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recommendation of DSMB (futility of Endpoints)
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-20
Primary completion date: 2023-07-13
Completion date: 2023-07-13
Plan to share individual participant data: NO
Clinical trial NCT03532087: Study to Identify the Impact of Denosumab on the Immune System in Patients With HER2 Negative Breast Cancer
Official title: Explorative Trial to Identify the Impact of Denosumab on the Systemic Immunity and Local Immunologic Microenvironment in Postmenopausal Patients With HER2 Negative Breast Cancer
Acronym: PERIDENO
Sponsor: Borstkanker Onderzoek Groep (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to new insights
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-02-28
Primary completion date: 2021-02-28
Completion date: 2023-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04419558: Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official title: Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: FibroGen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 372.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2023-09-04
Completion date: 2023-09-04
Baseline population: The intent-to-treat (ITT) population included all randomized participants.
Clinical trial NCT04920331: Study of Intravenous Erenumab in Patients With Status Migrainosus
Official title: STATUS STUDY: Pilot Open-Label Trial of Intravenous Erenumab in Patients With Status Migrainosus
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No Participants Enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-07
Primary completion date: 2022-02-04
Completion date: 2022-02-04
Clinical trial NCT04212221: MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients
Official title: A Multicenter, Open-label, Phase I/II Dose Escalation and Expansion Clinical Study to Assess the Safety and Efficacy of MGD013 Monotherapy and in Combination With Brivanib Alaninate (ZL-2301) in Patients With Advanced Liver Cancer
Sponsor: Zai Lab (Hong Kong), Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to the rapid shifting of liver cancer disease landscape and the company's adjustment of development strategy.
Enrollment: 89.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-20
Primary completion date: 2022-04-27
Completion date: 2022-04-27
Baseline population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).
Plan to share individual participant data: NO
Clinical trial NCT04299048: Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Official title: A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-17
Primary completion date: 2022-03-30
Completion date: 2022-03-30
Baseline population: The baseline analysis was performed on treated participants.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03922945: A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Official title: A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents
Sponsor: VIVUS LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 223.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-02
Primary completion date: 2021-04-16
Completion date: 2021-04-16
Plan to share individual participant data: NO
Clinical trial NCT05172141: A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
Official title: A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to the company's development strategy adjustment, Innovant Biologics decided not to continue this study after consultation with investigators.
Enrollment: 222.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2022-08-31
Completion date: 2023-01-31
Plan to share individual participant data: NO
Clinical trial NCT02978404: Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases
Official title: A Phase II, Multi-centre Study, of Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases From Non-small Cell Lung Cancer and Renal Cell Cancer
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-02
Primary completion date: 2021-01-31
Completion date: 2023-12-31
Clinical trial NCT02936206: Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
Official title: Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: low accrual rate
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2020-05-01
Completion date: 2020-05-01
Baseline population: There were 2 participants in the study, both randomized to Tamoxifen arm.
Plan to share individual participant data: NO
Clinical trial NCT03525613: A 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: 637.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-31
Primary completion date: 2021-06-28
Completion date: 2022-06-28
Baseline population: The intent-to-treat (ITT) analysis set included all subjects assigned to treatment.
Clinical trial NCT04088591: High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda
Official title: High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda: a Feasibility Trial
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Recent studies suggest an increase in mortality due to high-does Vitamin C
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-31
Primary completion date: 2023-11-30
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: All of the individual participant data will be shared, after de-identification, to researchers who present to the authors a methodologically sound proposal for meta-analysis. Proposals should be directed to dahopk@gmail.com.
IPD time frame: Beginning 6 months and ending 5 years after study publication.
IPD access criteria: This data will be made available to researchers who present to the authors a methodologically sound proposal for meta-analysis.
Clinical trial NCT04521621: A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)
Official title: A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 76.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-10-28
Primary completion date: 2023-07-25
Completion date: 2023-07-25
Baseline population: No participants were enrolled in Part 2 Cohort D or Part 2 Cohort E arms due to early study termination.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02628574: Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab
Official title: A Phase 1 Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab in Adults With Advanced Solid Tumors
Sponsor: Leap Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 109.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-01-31
Primary completion date: 2020-07-14
Completion date: 2020-07-14
Clinical trial NCT04958226: A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours
Official title: An Open-label, Fixed-sequence Study to Assess the Effect of Repeated Doses of Capivasertib on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Patients With Advanced Solid Tumours
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-15
Primary completion date: 2023-02-06
Completion date: 2023-02-15
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT05620160: Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of RAY1216 Tablets in Patients With Mild to Moderate SARS-CoV-2 Infection
Sponsor: Guangdong Raynovent Biotech Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1359.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-12
Primary completion date: 2023-01-19
Completion date: 2023-03-28
Clinical trial NCT05262842: JS001+IMP4297 in Patients With Advanced Cancer
Official title: A Phase Ⅰ/Ⅰb Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of Toripalimab (Anti-PD-1 Antibody) in Combination With Senaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors
Sponsor: Shanghai Junshi Bioscience Co., Ltd. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The sponsor voluntarily terminated the study before it was initiated
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-29
Primary completion date: 2024-04-06
Completion date: 2024-06-06
Plan to share individual participant data: NO
Clinical trial NCT02899026: Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in Subjects With Polymyalgia Rheumatica
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: GSK decision to return rights to sirukumab to Janssen and discontinue sirukumab development in polymyalgia rheumatica.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-03-15
Primary completion date: 2020-08-26
Completion date: 2021-08-26
Plan to share individual participant data: NO
Clinical trial NCT04508023: A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection
Official title: A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19 Infection
Acronym: PREVENT-HD
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated prematurely due to enrollment challenges.
Enrollment: 1284.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-13
Primary completion date: 2022-06-01
Completion date: 2022-06-01
Limitations and caveats: The study was terminated prematurely due to enrollment challenges.
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 NCT03417999: Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Official title: Dose Escalation Pharmacokinetic Study of Intranasal Atomized Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: All subjects who were enrolled completed the study. However, the PI left the institution and the study was terminated before all cohorts were enrolled.
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-14
Primary completion date: 2021-10-12
Completion date: 2021-10-12
Limitations and caveats: 1. Unable to enroll subjects in Cohort 1B to determine if DEX PK is different in patients spontaneously ventilating with a natural airway versus mechanically ventilated via oral endotracheal tube.~2. Unable to sample long enough to determine elimination phase of IN DEX.~3. Small sample size and heterogenous population limit interpretation of results.~4. COVID delayed enrollment and loss of research personnel.~5. PI left institution prior to completion of study and so study was terminated.
Plan to share individual participant data: NO
Clinical trial NCT05266586: Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study
Acronym: ROSE2
Sponsor: NewAmsterdam Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 119.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-09
Primary completion date: 2022-08-12
Completion date: 2022-09-08
Baseline population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Plan to share individual participant data: NO
Clinical trial NCT03417102: A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
Official title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX
Acronym: ATLAS-INH
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-14
Primary completion date: 2020-11-25
Completion date: 2021-06-23
Baseline population: Analysis was performed on Intent-to-Treat (ITT) population which included all randomized participants who were analyzed according to the randomized treatment arm.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04455958: Lopinavir/Ritonavir for the Treatment of COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year
Official title: A Double-Blind, Randomized, Placebo-Controlled Phase II Study of Lopinavir/Ritonavir Versus Placebo in COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: limited resources
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-01
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Clinical trial NCT04249076: Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)
Official title: A Phase 3, Multicenter, Randomized, Double-Masked Clinical Trial to Assess the Efficacy and Safety of Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% Compared to Placebo in the Treatment of Inflammation and Pain Associated With Cataract Surgery
Acronym: CLOSE-2
Sponsor: Salvat (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 215.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-04
Primary completion date: 2021-04-14
Completion date: 2021-04-14
Baseline population: Safety population
Plan to share individual participant data: NO
Clinical trial NCT03795233: Fecal Microbiota Transplant for Primary CDI
Official title: Fecal Microbiota Transplant (FMT) After Treatment for a First Episode of Clostridium Difficile Infection (CDI)
Sponsor: Boston Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated after a covid-related suspension and the unavailability of drug.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-23
Primary completion date: 2021-01-15
Completion date: 2021-01-15
Limitations and caveats: The study was terminated after a covid-related suspension and the unavailability of drug. Data were not collected for 5 of the 6 outcomes measures and no data were collected for the primary outcome measure as no participant was in the study at the timeframe of 11 months.
Plan to share individual participant data: NO
Clinical trial NCT04411316: Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
Official title: Pharmacomechanical Catheter-directed Thrombolysis (PCDT) Plus Anticoagulation Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis:
Sponsor: University of Toledo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Zero Patients met criteria
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-19
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Plan to share individual participant data: NO