chufangao/CTO huggingface dataset:
Clinical trial NCT03117530: Measuring Brain Inflammation in Autism
Official title: Targeting Microglial Activation for Treatment of Autism Spectrum Disorder (ASD): A Proof-of-Concept, Target-Engagement Study
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: COVID
Enrollment: 30.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2017-04-11
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
IPD sharing description: IPD will not be shared
Clinical trial NCT03953456: Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
Official title: A Double-Blind, Placebo-Controlled, Cross-over Phase II Study to Evaluate the Effect of a 6-week Elafibranor (120mg) Treatment Administered Once Daily on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
Sponsor: Genfit (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Continuation of the trial cannot serve a scientific purpose
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-16
Primary completion date: 2020-03-11
Completion date: 2020-07-14
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03884972: Trabectedin and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor
Official title: A Phase I/Ib Pilot Study of Combined Trabectedin and Venetoclax in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Request by sponsor due to no enrollment of participants on study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-18
Primary completion date: 2020-03-04
Completion date: 2020-03-04
Clinical trial NCT04843631: Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults
Official title: Bioequivalence Randomised, Double-blind, 3-parallel -Group Phase I Study of BFI-751 Compared With EU-STELARA® and US-STELARA® in Healthy Adult Volunteers
Sponsor: BioFactura Australia Pty Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 216.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-01
Primary completion date: 2021-12-08
Completion date: 2021-12-08
Plan to share individual participant data: NO
Clinical trial NCT05258851: Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections
Official title: Ceftazidime-Avibactam Versus Colistin in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections (AVI-ICU): A Non-Inferiority Randomized Clinical Trial
Acronym: AVI-ICU
Sponsor: King Faisal Specialist Hospital & Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Difficulties encountered in the recruitment process and slow enrollment. The study was not terminated due to any safety issues or concerns.
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-01
Primary completion date: 2023-04-12
Completion date: 2024-01-28
Plan to share individual participant data: NO
Clinical trial NCT04039919: A Study to Test the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single-Center, Cross-Over Study to Investigate the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrollment: 40.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-07-17
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Baseline population: Baseline Characteristics refer to Safety Set (SS) which consisted of all study participants who were randomized and had received at least 1 dose (any amount) of study medication.
Limitations and caveats: The study was terminated because the decision was made to terminate the PSL development program in focal-onset seizures on 22 May 2020.
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT03739138: Intratumoral/Intralesional Administration of MK-4621/JetPEI™ With or Without Pembrolizumab in Participants With Advanced/Metastatic or Recurrent Solid Tumors (MK-4621-002)
Official title: A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of MK-4621/JetPEI as Monotherapy or in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Solid Tumors
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 30.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-18
Primary completion date: 2021-03-02
Completion date: 2021-03-02
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05622591: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML
Official title: Dose Escalation Study to Evaluate the Safety and Tolerability of ELU001 in Pediatric Patients Who Have Relapsed and/or Refractory CBFA2T3::GLIS2 Positive Acute Myeloid Leukemia
Acronym: Pediatric AML
Sponsor: Elucida Oncology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of Funding - no safety issue with Drug; Company Permanently Closed
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-06-07
Primary completion date: 2024-06-07
Completion date: 2024-06-07
Plan to share individual participant data: NO
Clinical trial NCT05035095: Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Official title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
Acronym: OASIS 1
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 667.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-13
Primary completion date: 2023-03-24
Completion date: 2023-05-12
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04270487: The DOMINO Trial: Diet Or Medication in Irritable Bowel syNdrOme
Official title: A Randomized Controlled Trial to Evaluate the Short-term Efficacy and Long-term Health Economic Impact of a Dietary Intervention Compared to Pharmacotherapy With a Musculotropic Spasmolytic Agent for Newly Diagnosed or Newly Treated Irritable Bowel Syndrome in Primary Care
Acronym: DOMINO
Sponsor: Universitaire Ziekenhuizen KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 472.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-26
Primary completion date: 2020-05-04
Completion date: 2020-07-06
Clinical trial NCT02716688: S-1 and Radiotherapy for Elderly Esophageal Cancer Patients
Official title: A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
Sponsor: Zhejiang Provincial People's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No patients enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-31
Primary completion date: 2019-12-31
Completion date: 2020-12-31
Clinical trial NCT05157360: HAT for the Treatment of Sepsis Associated With NASTI
Official title: Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis Associated With Acute Necrotizing Soft Tissue Infections, The NASTI HAT Trial
Sponsor: Ascension Via Christi Hospitals Wichita, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: slow recruitment and not anticipated to meet recruitment numbers
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-10
Primary completion date: 2023-05-16
Completion date: 2023-05-16
Limitations and caveats: Due to the small number of participants enrolled, the findings are observational only.
Plan to share individual participant data: NO
Clinical trial NCT03485092: Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects
Official title: Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus (or Pre-diabetes) and Heart Failure (SUGAR-DM-HF)
Acronym: SUGAR-DM-HF
Sponsor: NHS Greater Glasgow and Clyde (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 105.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-16
Primary completion date: 2020-03-28
Completion date: 2020-03-28
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04991740: A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors
Official title: A Phase 1 Study of JNJ-78306358, a T Cell Redirecting Bispecific Antibody Targeting HLA-G for Advanced Stage Solid Tumors
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-24
Primary completion date: 2023-02-09
Completion date: 2023-02-09
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 NCT03421756: Stem Cell Transplant in Patients With Severe Sickle Cell Disease
Official title: A Pilot Study Evaluating the Efficacy of Non-Myeloablative Matched Related Donor Peripheral Blood Stem Cell Transplant in Patients With Severe Sickle Cell Disease
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Trial terminated due to low rate of enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-29
Primary completion date: 2018-09-15
Completion date: 2022-05-15
Plan to share individual participant data: NO
Clinical trial NCT04740931: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Official title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Acronym: COMINO
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 729.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-02
Primary completion date: 2022-08-09
Completion date: 2023-07-12
Baseline population: ITT Population: All global participants who were randomized in the study, according to the assigned treatment.
Plan to share individual participant data: YES
IPD sharing description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Clinical trial NCT02677181: Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Official title: Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
Sponsor: Chinese PLA General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2020-01-31
Completion date: 2022-04-30
Plan to share individual participant data: NO
Clinical trial NCT04724837: Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
Official title: A Phase 2b Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients With Chronic Kidney Disease With Estimated Glomerular Filtration Rate (eGFR) ≥ 20 mL/Min/1.73 m^2
Acronym: ZENITH-CKD
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 542.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-28
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Baseline population: The full analysis set included all participants who were randomised and received any study intervention.
Limitations and caveats: No multiple testing correction was considered in this early phase study.
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 requests 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 de-identified 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 NCT04900038: A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
Official title: A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults
Acronym: DYNAMIC
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision to stop compound development. The decision was not based on any safety or efficacy concerns. It reflected the company strategy for portfolio progression.
Enrollment: 85.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-08-18
Primary completion date: 2022-11-22
Completion date: 2023-05-11
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, a 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 NCT04209530: Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women
Official title: A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology
Sponsor: Endo Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to COVID-19 impact
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-20
Primary completion date: 2020-07-23
Completion date: 2020-10-05
Plan to share individual participant data: YES
Clinical trial NCT05423106: A Single and Multiple Ascending Dose Study of JNJ-64457744
Official title: A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic business decision, not due to safety concerns
Enrollment: 60.0 (ACTUAL)
Number of arms: 7.0
Start date: 2022-07-04
Primary completion date: 2023-03-14
Completion date: 2023-03-20
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 NCT03081039: A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
Official title: A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma
Sponsor: University of Louisville (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Competing study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-21
Primary completion date: 2022-04-28
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04754334: A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
Official title: A Double-Blind, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy.
Sponsor: Oramed, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol.
Enrollment: 346.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-16
Primary completion date: 2023-01-13
Completion date: 2023-01-13
Plan to share individual participant data: NO
Clinical trial NCT04198649: Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
Official title: Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
Acronym: AZITHROPARO
Sponsor: University Hospital, Strasbourg, France (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: not enough patients
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-02
Primary completion date: 2023-11-02
Completion date: 2023-11-02
Clinical trial NCT04912115: Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia
Official title: A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo- Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa- Induced Dyskinesia in Subjects With Parkinson's Disease
Sponsor: PharmaTher Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Seeking Pivotal study initiation
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-05
Primary completion date: 2023-12-30
Completion date: 2024-03-30
Clinical trial NCT02356991: A Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
Official title: A Randomized,Double-Blind, Placebo-Controlled, Multicenter, Phase II Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: sponsor decides to suspend this trial
Enrollment: 137.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-12-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT04568031: Study of AZD1222 for the Prevention of COVID-19 in Japan
Official title: A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 256.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-23
Primary completion date: 2021-11-22
Completion date: 2021-11-22
Baseline population: The Total vaccinated analysis set (TVS) included all participants who received at least 1 dose of study vaccination.
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 de-identified 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 NCT05109702: A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Official title: A Phase 3, Multicenter, Randomized, Double Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% Compared to Placebo in Subjects With Dry Eye
Acronym: VELOS-3
Sponsor: HanAll BioPharma Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 260.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-18
Primary completion date: 2022-05-06
Completion date: 2022-05-06
Baseline population: Intent-to-Treat (ITT) Population included all randomized participants.
Plan to share individual participant data: NO