chufangao/CTO huggingface dataset:
Clinical trial NCT01660451: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Official title: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 227.0 (ACTUAL)
Number of arms: 3.0
Start date: 2012-11-19
Primary completion date: 2016-06-22
Completion date: 2023-05-18
Baseline population: Full Analysis Set (FAS) included all participants assigned to study treatment.
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT03457701: Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
Official title: A Repeat Dose, Open Label, Two Period, Randomized, Cross Over Study to Compare the Effect of Daprodustat to Recombinant, Human Erythropoietin (rhEPO) on Oral Iron Absorption in Adult Participants With Anemia Associated With Chronic Kidney Disease Who Are Not on Dialysis
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-30
Primary completion date: 2022-07-05
Completion date: 2022-07-05
Baseline population: Safety population comprised of participants who received at least 1 dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months .
Clinical trial NCT05319028: Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Official title: A Phase 2 Study of Mivavotinib in Biomarker-Defined Subgroups of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor: Calithera Biosciences, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-23
Primary completion date: 2023-02-24
Completion date: 2023-02-24
Clinical trial NCT04943627: Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)
Official title: A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA)
Sponsor: Agenus Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Strategic Business Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-02
Primary completion date: 2021-10-22
Completion date: 2021-10-22
Clinical trial NCT04308668: Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
Official title: Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial
Acronym: COVID-19 PEP
Sponsor: University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1312.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-17
Primary completion date: 2020-05-20
Completion date: 2020-05-20
Plan to share individual participant data: YES
IPD sharing description: De-identified dataset will be available within 1 month of publication.
IPD time frame: at time of publication
IPD access criteria: To be publicly provided. Please register at the website to receive the dataset.
Clinical trial NCT02819856: SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity
Sponsor: Sound Pharmaceuticals, Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-07-21
Primary completion date: 2023-04-07
Completion date: 2023-04-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05788497: Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids
Official title: Multicentre, Double-blind, Randomised Clinical Trial to Evaluate and Compare the Efficacy and Safety of Hemorrane Plus (Hemorrane® + Benzocaine) With Hemorrane® and With Placebo in Patients With Uncomplicated Haemorrhoids
Sponsor: Faes Farma, S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recruitment failure
Enrollment: 21.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-30
Primary completion date: 2024-01-04
Completion date: 2024-01-04
Clinical trial NCT04341727: Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection
Official title: Open-label, Randomized Controlled Trial of Hydroxychloroquine, Hydroxychloroquine Plus Azithromycin, Chloroquine Alone, Chloroquine Plus Azithromycin in the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) Infection
Acronym: WU352
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: DSMB recommended study suspension slow accrual
Enrollment: 30.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-04-04
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Limitations and caveats: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Plan to share individual participant data: NO
Clinical trial NCT02409342: A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
Official title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 572.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-07-20
Primary completion date: 2020-02-04
Completion date: 2022-03-08
Clinical trial NCT02059265: Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer
Official title: A Phase II Trial of DCTD-Sponsored Dasatinib in Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Interim monitoring
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-02-14
Primary completion date: 2017-02-06
Completion date: 2023-06-26
Clinical trial NCT02478255: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Official title: Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-21
Primary completion date: 2022-01-13
Completion date: 2022-01-13
Clinical trial NCT03195270: Use of PET/MR Imaging in Chronic Pain
Official title: Use of [18F]FDG PET/MRI in the Diagnosis of Pain Generators and/or Sites of Inflammation and to Monitor Treatment Effects in Patients With Chronic Pain
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-11-24
Primary completion date: 2022-01-20
Completion date: 2022-01-20
Plan to share individual participant data: NO
IPD sharing description: There is currently no plan to share the individual participant data with other researchers outside our group of researchers or referring physicians.
Clinical trial NCT02163759: A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
Official title: Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors
Acronym: HIBISCUS I
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 358.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-11-04
Primary completion date: 2020-02-19
Completion date: 2020-03-19
Baseline population: The overall number of baseline participants (716) represents the total number enrolled (358) in this study, GA28948 (NCT02163759), plus the total number enrolled (358) in a second study of identical design, GA28949 (NCT02171429). Some of the pre-specified secondary outcome measure comparisons were planned to be evaluated by pooling data from both studies; all etrolizumab versus adalimumab comparisons and one family of etrolizumab versus placebo comparisons were evaluated on pooled data.
Clinical trial NCT04488003: Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Official title: A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Sponsor: BioMed Valley Discoveries, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment challenges
Enrollment: 104.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-07
Primary completion date: 2023-02-15
Completion date: 2023-05-23
Limitations and caveats: Early termination leading to small numbers of patients analyzed.
Plan to share individual participant data: NO
Clinical trial NCT03092635: AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Official title: Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Original principal investigator departed institution and concluded the study upon departure.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-06
Primary completion date: 2021-11-10
Completion date: 2022-04-22
Plan to share individual participant data: NO
Clinical trial NCT04493151: Imipenem/Cilastatin/Relebactam PK in ECMO
Official title: Pharmacokinetics of Imipenem/Cilastatin/Relebactam in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)
Sponsor: Hartford Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-01
Primary completion date: 2023-05-31
Completion date: 2023-06-30
Limitations and caveats: A study limitation is the protocol defined exclusion of patients on concomitant continuous renal replacement therapy (CRRT), which is common in patients receiving ECMO (extracorporeal membrane oxygenation). Dosing modifications may be necessary in patients receiving both CRRT and ECMO.
Plan to share individual participant data: NO
Clinical trial NCT05788289: A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma
Official title: Phase 2 Study of Tafasitamab and Lenalidomide in Relapsed or Refractory Mantle Cell Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual rate
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-03-14
Primary completion date: 2024-08-01
Completion date: 2024-08-01
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT00914940: Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
Official title: A Multi-center Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Did not reach one of the primary endpoints of decreased total acute GVHD
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2009-12-17
Primary completion date: 2019-12-01
Completion date: 2020-05-26
Clinical trial NCT02012296: Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer
Official title: A Phase I/II Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Mifepristone for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC)
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-12-13
Primary completion date: 2019-06-10
Completion date: 2020-08-01
Clinical trial NCT02538432: Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors
Official title: 15xxGCC: PHASE II TRIAL OF THE EP4 RECEPTOR ANTAGONIST, AAT-007 (RQ-07; CJ-023,423) IN ADVANCED SOLID TUMORS
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI No Longer at University of Maryland. Now at Fox Chase
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-30
Primary completion date: 2019-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04321967: Nitropaste in Breast Reduction
Official title: Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Unable to recruit patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-20
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Plan to share individual participant data: NO
IPD sharing description: There is not a plan to make IPD and related data dictionaries available. The PI does not plan to share data at the conclusion of the study beyond what is published
Clinical trial NCT02921373: Tracking Peripheral Blood Mononuclear Cells With Fluorine MRI
Official title: A Phase I Study Evaluating the Feasibility of Using Fluorine-19 Cell Sense to Image Human Peripheral Blood Mononuclear Cells In Vivo
Acronym: TRACK
Sponsor: Western University, Canada (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-31
Primary completion date: 2022-06-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
IPD sharing description: Only group data will be presented
Clinical trial NCT02926235: Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty
Official title: Randomized Control Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty
Acronym: Amino Acid
Sponsor: Hospital for Special Surgery, New York (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-30
Primary completion date: 2022-05-14
Completion date: 2022-05-14
Clinical trial NCT03665311: Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis Feasibility Study
Official title: Saline Versus Albumin Fluid for Extracorporeal Removal With Slow Low Efficiency Dialysis (SAFER-SLED): A Feasibility Study
Acronym: SAFER-SLED
Sponsor: Ottawa Hospital Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-25
Primary completion date: 2020-01-15
Completion date: 2020-01-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05001282: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)
Official title: Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors
Sponsor: Elucida Oncology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of Funding - no safety issue with Drug; Company Permanently Closed
Enrollment: 79.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-13
Primary completion date: 2024-06-07
Completion date: 2024-06-07
Plan to share individual participant data: NO
Clinical trial NCT05473234: Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Official title: Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was halted due to low follow-up rates and issues with data collection
Enrollment: 307.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-06
Primary completion date: 2023-11-29
Completion date: 2023-11-29
Plan to share individual participant data: NO
Clinical trial NCT02591173: Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure
Official title: Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Difficulty recruiting
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Clinical trial NCT05125068: Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
Official title: A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy
Sponsor: Eledon Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: An administrative decision was made to terminate the AT-1501-N205 study. This voluntary business-related decision was not related to the safety of tegoprubart (AT-1501). Available safety data demonstrated tegoprubart to be safe and well tolerated.
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-21
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Clinical trial NCT03410693: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
Official title: A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy
Acronym: FORT-1
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 175.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-31
Primary completion date: 2020-10-27
Completion date: 2020-10-27
Clinical trial NCT03785678: Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
Official title: A Phase III, Prospective, Double-blind, Randomized, Placebo-controlled Trial of Thrombolysis in Imaging-eligible, Late-window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS)
Acronym: TIMELESS
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 458.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-02
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Clinical trial NCT02525861: GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
Official title: A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following Glassia Therapy in A1PI-Deficient Subjects
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-08
Primary completion date: 2020-07-29
Completion date: 2020-07-29
Baseline population: Safety analysis set consisted of all enrolled participants who received any amount of investigational product (IP), regardless of protocol deviations or non-adherence to study procedures.
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.