chufangao/CTO huggingface dataset:
Clinical trial NCT02039674: A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
Official title: A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 267.0 (ACTUAL)
Number of arms: 14.0
Start date: 2014-02-21
Primary completion date: 2016-11-07
Completion date: 2021-10-18
Baseline population: For Cohorts A, B, C and G, the analysis population consisted of all randomized participants. For Cohorts D, E, F and H, the analysis population consisted of all treated participants.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
Clinical trial NCT06245291: Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection
Official title: A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection
Sponsor: Arbutus Biopharma Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2024-05-01
Primary completion date: 2024-08-01
Completion date: 2024-08-01
Clinical trial NCT02485366: Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Official title: Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Product unavailability
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-30
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Clinical trial NCT02519543: Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder
Official title: Treating Insulin Resistance to Improve Outcome in Refractory Bipolar Disorder: a Randomized, Double-blind, Placebo-control Study of the Efficacy of Metformin in Patients With Insulin Resistance and Non-remitting Bipolar Illness
Acronym: TRIO-BD
Sponsor: Nova Scotia Health Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
Clinical trial NCT02403193: Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: Phase I/Ib Trial of Single Agent PBF-509 and in Combination With PDR001 for Patients With Advanced NSCLC
Acronym: AdenONCO
Sponsor: Palobiofarma SL (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 92.0 (ACTUAL)
Number of arms: 9.0
Start date: 2015-10-31
Primary completion date: 2021-10-31
Completion date: 2021-11-24
Clinical trial NCT04542694: Study of Favipiravir Compared to Standard of Care in Hospitalized Patients With COVID-19
Official title: Open-label Randomized Multicenter Comparative Study on the Efficacy and Safety of Areplivir Film-coated Tablets (PROMOMED RUS LLC, Russia) in Patients Hospitalized With COVID-19
Sponsor: Promomed, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-21
Primary completion date: 2020-08-10
Completion date: 2020-08-20
Plan to share individual participant data: NO
Clinical trial NCT04866017: A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Official title: A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the ociperlimab program.
Enrollment: 63.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-17
Primary completion date: 2023-10-17
Completion date: 2023-10-17
Plan to share individual participant data: YES
Clinical trial NCT03193931: Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers
Official title: A Randomized Phase II Study Comparing Pembrolizumab With Methotrexate in Elderly, Frail or Cisplatin-ineligible Patients With Head and Neck Cancers
Acronym: ELDORANDO
Sponsor: AIO-Studien-gGmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A very low recruitment rate made it impossible to reach the recruitment goal wthin an acceptable timeframe.
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-02
Primary completion date: 2021-11-24
Completion date: 2022-03-23
Plan to share individual participant data: NO
Clinical trial NCT01991873: Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer
Official title: Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer
Acronym: PanaMa
Sponsor: AIO-Studien-gGmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 387.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-04-30
Primary completion date: 2023-02-18
Completion date: 2023-02-18
Clinical trial NCT04544709: Intradiscal Platelet Rich Plasma
Official title: Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-14
Primary completion date: 2022-07-29
Completion date: 2022-07-29
Baseline population: Baseline information was collected from 3 participants before the study was discontinued early.
Limitations and caveats: The single greatest limitation is that the study was ended early due to extremely low participant enrollment.
Plan to share individual participant data: NO
Clinical trial NCT01332968: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Official title: A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1401.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-07-06
Primary completion date: 2016-02-01
Completion date: 2021-07-30
Baseline population: The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.
Clinical trial NCT04062838: Prolotherapy for the Treatment of Partial Rotator Cuff Tears
Official title: Prospective Pilot Study: Prolotherapy For The Treatment Of Patients With Partial Rotator Cuff Tears
Sponsor: Hadassah Medical Organization (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: I did not receive funding to finance this study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-08-01
Primary completion date: 2021-12-01
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT02608268: Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
Official title: Phase I-Ib/II Open-label Multi-center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 252.0 (ACTUAL)
Number of arms: 10.0
Start date: 2015-11-23
Primary completion date: 2022-08-30
Completion date: 2022-08-30
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04670653: Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis
Official title: National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years.
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-01
Primary completion date: 2023-07-31
Completion date: 2023-10-31
Clinical trial NCT03483688: A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects
Official title: A Phase Ⅰb Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Sponsor: Peking Union Medical College Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-06
Primary completion date: 2019-12-10
Completion date: 2020-01-10
Clinical trial NCT01665274: Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer
Official title: A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection
Acronym: repeat
Sponsor: Harbin Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: we are working on a larger similar multicenter cinical trials as a participant.so in order to avoid conflicts of interest, we have to suspended this project.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-09-30
Primary completion date: 2020-08-31
Completion date: 2022-09-30
Clinical trial NCT01218555: Study of Everolimus (RAD001) in Combination With Lenalidomide
Official title: Phase I Study of Everolimus (RAD001) in Combination With Lenalidomide in Patients With Advanced Solid Malignancies Enriched for Renal Cell Carcinoma
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-09-09
Primary completion date: 2020-11-05
Completion date: 2020-11-05
Clinical trial NCT04775797: Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AB-836, an HBV Capsid Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection
Sponsor: Arbutus Biopharma Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Safety
Enrollment: 110.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-06-25
Primary completion date: 2022-11-17
Completion date: 2022-11-17
Plan to share individual participant data: NO
Clinical trial NCT03722108: Regorafenib Combined With Irinotecan as Second-line in Patients With Metastatic Gastro-oesophageal Adenocarcinomas
Official title: A Randomised Phase 2 Trial Assessing REGorafenib Combined With IRInotecan as Second-line Treatment in Patients With Metastatic Gastro-oesophageal Adenocarcinomas
Acronym: REGIRI
Sponsor: UNICANCER (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Unfavorable benefit-risk balance in the experimental arm following the IDMC for intermediate efficacy and safety analysis
Enrollment: 89.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-07
Primary completion date: 2022-05-19
Completion date: 2022-05-19
Plan to share individual participant data: NO
IPD sharing description: Individual Participant Data will not be shared at an individual level, they will be part of the study database including all enrolled patients
Clinical trial NCT04479371: Liposomal Bupivacaine vs Standard Penile Block for Hypospadias Repair
Official title: Prospective Randomized Trial of Penile Nerve Block With Liposomal Bupivacaine for Hypospadias Repair vs Standard Penile Block With Bupivacaine
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Limited funding and resources to complete FDA requirements for enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-31
Primary completion date: 2022-07-30
Completion date: 2023-07-30
Plan to share individual participant data: YES
IPD sharing description: An adequate plan is in place to protect the patient identifiers. The plan includes that the electronic datasheet will reside in the researchers UTSW secure O:drive and will not be transmitted outside the institution as this is a PI-initiated trial. The UTSW HRPP/IRB offices, Children's and UTSW offices of research administration, and any state or federal monitors may be given access to study records or data on site, as necessary. The data will be password protected, passwords will be changed on a regular basis, access to the data will be restricted to the research team only, and all paper records will be kept in locked file cabinets and access limited to authorized personnel only. The identifiers will be destroyed after the de-identified results have been submitted for publication.
IPD time frame: Until trial completion and data publication in 2023
IPD access criteria: Research team only
Clinical trial NCT04217148: The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
Official title: The Combination of Oral All-trans Retinoic Acid and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial
Sponsor: Peking University People's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 132.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-01
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to data, including deidentified individual participant data, and the study protocol from this clinical trial. These data will be available beginning 3 months and ending 36 months following publication. All requests must include a description of the research proposal and be sent to the corresponding author (zhangxh@bjmu.edu.cn). Data requestors will need to sign a data access agreement to obtain access.
IPD time frame: These data will be available beginning 3 months and ending 36 months following publication.
IPD access criteria: All requests must include a description of the research proposal and be sent to the corresponding author (zhangxh@bjmu.edu.cn). Data requestors will need to sign a data access agreement to obtain access.
Clinical trial NCT03176277: A Study of ONO-7475 in Patients With Acute Leukemias
Official title: A Phase I/II Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias or Myelodysplastic Syndromes
Sponsor: Ono Pharmaceutical Co. Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Protocol defined futility criteria
Enrollment: 42.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-06-26
Primary completion date: 2022-12-01
Completion date: 2023-01-20
Baseline population: Full analysis set, respective of Part A and Part D study.
Plan to share individual participant data: NO
Clinical trial NCT02647762: CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis
Official title: A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis
Sponsor: Can-Fite BioPharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Interim analysis results
Enrollment: 244.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-10-30
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Clinical trial NCT04885491: A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in COVID-19 Patients With Acute Pulmonary Hypertension
Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of PDNO (Nitrosooxypropanol) Infusion in COVID-19 Patients With Acute Pulmonary Hypertension
Sponsor: Attgeno AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Since the availability of vaccines, a drastic drop in number of patients with increased PAP was observed and when the WHO re-categorized the COVID-19 pandemic from PHEIC to an established and ongoing health issue the study was withdrawn.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-07
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT03744676: A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)
Official title: A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting
Sponsor: Juno Therapeutics, a Subsidiary of Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-29
Primary completion date: 2023-09-22
Completion date: 2023-09-22
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT03901612: Erector Spinae Catheter for Open Heart Surgery
Official title: Evaluation of a Peri-Operative Continuous Bilateral Erector Spinae Plane (ESP) Continuous Catheter After Open Cardiac Surgery in Adults
Acronym: ESPADULT2
Sponsor: Vinmec Healthcare System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: covid and surgeon left
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-05
Primary completion date: 2023-08-14
Completion date: 2023-08-14
Plan to share individual participant data: NO
Clinical trial NCT05024058: Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Official title: A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Acronym: PEARL-PROVOKE
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.
Enrollment: 39.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-11-16
Primary completion date: 2022-08-09
Completion date: 2022-08-09
Baseline population: The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of study drug. Participants were analyzed according to the treatment they were assigned. Data could not be analyzed because no subject completed Week 12 in the sympomatic dermographism cohort, 1 subject each completed the Week 12 in 72 mg ligelizumab and 120 mg ligelizumab groups in cold urticaria cohort, 1 subject completed Week 12 in cholinergic urticaria cohort.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT03054870: A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Official title: A Comparison of Technegas® and Xenon 133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy
Sponsor: Cyclomedica Australia PTY Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Trial met primary efficacy endpoint target. No additional subjects necessary.
Enrollment: 226.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-01
Primary completion date: 2020-09-18
Completion date: 2020-11-23
Baseline population: Safety cohort - subjects who received any dose of Technegas
Limitations and caveats: Unblinded analysis of imaging efficacy data was to be done at completion of study and all blinded readings. Due to the COVID-19 pandemic impact on enrollment, FDA recommended an unplanned interim analysis be performed using blind read data from 200 subjects. Interim analysis was done by independent 3rd party statistician and reviewed by a Data Efficacy Monitoring Committee (DEMC), which recommended termination of the study based on positive results. Sponsor agreed.
Plan to share individual participant data: NO