chufangao/CTO huggingface dataset:
Clinical trial NCT04525352: A Trial to Evaluate Safety and Efficacy of RP-L401-0120 in Subjects With Infantile Malignant Osteopetrosis
Official title: A Phase I Clinical Trial for Gene Therapy in Infantile Malignant Osteopetrosis (IMO) to Evaluate the Safety and Preliminary Efficacy of Autologous CD34+ Enriched Cells Transduced With a LV Vector Encoding the TCIRG1 Gene
Sponsor: Rocket Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study discontinued due to feasibility.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-19
Primary completion date: 2021-05-21
Completion date: 2021-05-21
Clinical trial NCT02549170: A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Official title: A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 138.0 (ACTUAL)
Number of arms: 5.0
Start date: 2015-12-15
Primary completion date: 2022-02-23
Completion date: 2022-02-23
Baseline population: Epoch 1 safety analysis set included all participants who received any study treatment.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03116113: A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112
Official title: A Dose Escalation (Phase 1), and Dose Expansion (Phase 2/3) Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using an Adeno-Associated Viral Vector (AAV8) Encoding Retinitis Pigmentosa GTPase Regulator (RPGR)
Acronym: XIRIUS
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 9.0
Start date: 2017-03-08
Primary completion date: 2020-11-18
Completion date: 2020-11-18
Baseline population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT06197217: Phase III Clinical Study Evaluating the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of WPV01 in Patients With Mild to Moderate COVID-19
Sponsor: Westlake Pharmaceuticals (Hangzhou) Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1350.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-06-14
Primary completion date: 2023-08-21
Completion date: 2023-09-20
Clinical trial NCT04237649: KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors
Official title: A Phase I/Ib, Open-label, Multi-center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients With Advanced Solid Tumors
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 77.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-20
Primary completion date: 2023-09-15
Completion date: 2023-09-15
Plan to share individual participant data: NO
Clinical trial NCT05076422: A Study to Test How Well Men Tolerate Different Doses of BI 3006337
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-18
Primary completion date: 2023-03-03
Completion date: 2023-03-03
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Clinical trial NCT03816488: Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control
Official title: Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control - A Placebo-Controlled Internal Feasibility Trial
Acronym: OPTIM(i)SING
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Unable to source salsalate.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-12-01
Primary completion date: 2024-06-01
Completion date: 2024-12-01
Plan to share individual participant data: NO
Clinical trial NCT05094050: Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease
Official title: Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-01-18
Primary completion date: 2023-03-17
Completion date: 2023-03-17
Plan to share individual participant data: NO
Clinical trial NCT04910165: Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
Official title: Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty
Sponsor: St. Luke's Hospital, Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-01
Primary completion date: 2021-09-15
Completion date: 2021-10-15
Limitations and caveats: Block efficacy is dependent on the performing anesthesiologist, with multiple performing anesthesiologists introducing variability that was not accounted for. The use of drains was surgeon specific rather than part of our study protocol. The state's online drug monitoring program reports narcotic prescriptions filled but not necessarily taken possibly pointing to a discrepancy. Finally, all patients were obtained from one demographic area, and all surgeries were only performed by two surgeons
Plan to share individual participant data: NO
Clinical trial NCT03683667: Protein Plus: Improving Infant Growth Through Diet and Enteric Health
Official title: Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants
Acronym: JiVitA-6
Sponsor: Johns Hopkins Bloomberg School of Public Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 5283.0 (ACTUAL)
Number of arms: 8.0
Start date: 2018-09-23
Primary completion date: 2020-03-19
Completion date: 2020-03-24
Plan to share individual participant data: NO
Clinical trial NCT03853694: Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
Official title: A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)
Acronym: CHOICE
Sponsor: Pacira Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 167.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-04
Primary completion date: 2020-01-09
Completion date: 2020-01-16
Plan to share individual participant data: NO
Clinical trial NCT04512261: TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
Official title: TOPAZ: Single Arm, Open Label Phase 1b/2 Study of Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases
Acronym: TOPAZ
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Study withdrawn due to change in treatment landscape for HER2+ metastatic breast cancer.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-01
Primary completion date: 2024-06-01
Completion date: 2024-06-01
Clinical trial NCT03460704: Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium.
Official title: Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa
Acronym: PROMIS-II
Sponsor: Zambon SpA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was brought to an early close in March 2022 due to major ongoing recruitment issues primarily related to the COVID-19 pandemic and concerns regarding the continued randomization and exposure of subjects to placebo in the study.
Enrollment: 287.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-29
Primary completion date: 2022-03-15
Completion date: 2022-03-15
Baseline population: The modified Intention-To-Treat (mITT) Population is the Full Analysis Set and comprised all subjects who provided informed consent, were randomised and received at least 1 dose or partial dose of the IMP.
Clinical trial NCT02571530: Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
Official title: Phase 1 Trial of Super-selective Intra-arterial Cerebral Infusion of Trastuzumab After Blood-Brain Barrier Disruption for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
Sponsor: Northwell Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-31
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Clinical trial NCT04849273: A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
Official title: A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
Sponsor: Turning Point Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Adverse change in the risk/benefit.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-28
Primary completion date: 2023-04-18
Completion date: 2023-04-18
Clinical trial NCT01120028: Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
Official title: Open-label, Randomised Multicentre Study of CAMPATH-1H Versus Basiliximab Induction Treatment and Sirolimus Versus Tacrolimus Maintenance Treatment for the Preservation of Renal Function in Patients Receiving Kidney Transplants
Acronym: 3C
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 852.0 (ACTUAL)
Number of arms: 4.0
Start date: 2010-09-30
Primary completion date: 2014-02-28
Completion date: 2020-03-31
Baseline population: Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab).~Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Plan to share individual participant data: YES
IPD sharing description: Proposals for substudies must be approved by the Steering Committee. Procedure for accessing the data for this study are available on https://www.ndph.ox.ac.uk/data-access
IPD access criteria: See URL
Clinical trial NCT03181035: Correlation of FAZA PET Hypoxia Imaging To 3D Histology in Oral Tongue Cancer
Official title: Defining a Personalized Hypoxic Radiation Target Through Correlation of Functional F18-FAZA PET Imaging to Pimonidazole-stained 3D Whole-mounted Histological Specimen
Acronym: FAITH
Sponsor: Sunnybrook Health Sciences Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Pause to enrolment due to COVID-19 pandemic and protocol amendment (change to equipment used)
Enrollment: 10.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2018-01-25
Primary completion date: 2024-09-30
Completion date: 2024-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02580058: A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
Official title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 566.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-12-21
Primary completion date: 2018-09-19
Completion date: 2022-07-12
Plan to share individual participant data: YES
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 NCT02739035: MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Official title: Manipulation Under Anesthesia (MUA) to Treat Postoperative Stiffness After Total Knee Arthroplasty: A Multicenter Randomized Clinical Trial
Acronym: MUA
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 130.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-30
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Limitations and caveats: Participant dropout rates were higher than anticipated for in the initial enrollment calculations, and patient reported outcome surveys had low completion rates. As a result, the target of 90 power for results was not achieved for all study outcome metrics. Additional study is warranted regarding NSAID administration strategy for MUA patients in order to determine if NSAIDs can be useful in combatting the inflammatory cascade which is associated with arthrofibrosis and post TKA stiffness.
Plan to share individual participant data: NO
Clinical trial NCT02607930: Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 631.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-11-13
Primary completion date: 2017-05-09
Completion date: 2021-07-02
Baseline population: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT03884959: A Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients
Official title: A Prospective, Open Label, Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients
Sponsor: HLB Cell Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decided to stop enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-12
Primary completion date: 2020-11-04
Completion date: 2020-11-04
Clinical trial NCT05461794: Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Official title: A Phase 2, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Patients With Locally Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma That Progressed on or After Anti-PD-(L)1 Antibody Therapy
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to modification of company strategy.
Enrollment: 96.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-10-03
Primary completion date: 2024-02-26
Completion date: 2024-02-26
Plan to share individual participant data: YES
Clinical trial NCT04655586: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19
Official title: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19)
Acronym: ASPEN
Sponsor: ARCA Biopharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 160.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-10
Primary completion date: 2021-12-06
Completion date: 2022-03-07
Baseline population: The study was designed as a sequential Phase 2B/3 trial whereby both trial phases were nested in a common protocol. When the 2B top line results dictated substantial design changes for progression to Phase 3 the study was concluded as a Phase 2 trial.
Plan to share individual participant data: NO
Clinical trial NCT05095246: A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis
Official title: A Phase I Study of Inhaled KB407, a Replication-Incompetent, Non-Integrating Vector Expressing Human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), for the Treatment of Cystic Fibrosis
Sponsor: Krystal Biotech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Pandemic, logistical, and recruitment challenges
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-08
Primary completion date: 2024-07-01
Completion date: 2024-10-30
Plan to share individual participant data: NO
Clinical trial NCT05671653: A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range
Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-19
Primary completion date: 2023-11-03
Completion date: 2023-11-03
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 NCT03684044: Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
Official title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 363.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-08
Primary completion date: 2020-03-16
Completion date: 2020-03-16
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).