chufangao/CTO huggingface dataset:
Clinical trial NCT04326283: Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral Sclerosis
Sponsor: Genuv Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated as it is considered that necessary data have been collected
Enrollment: 23.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-02
Primary completion date: 2023-04-28
Completion date: 2023-04-28
Plan to share individual participant data: NO
Clinical trial NCT04621149: An Outpatient Study Investigating Non-prescription Treatments for COVID-19
Official title: A Phase 2 Screening Study of Candidate Non-prescription Treatments for COVID-19: A Patient-driven, Randomized, Factorial Study Evaluating Patient-reported Outcomes (PROFACT-01)
Acronym: PROFACT-01
Sponsor: Profact, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unable to recruit participants due to decline in COVID-19.
Enrollment: 10.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-11-15
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Plan to share individual participant data: NO
Clinical trial NCT05083117: Safety and Efficacy of Inhaled XW001 For Hospitalized COVID-19 Patients Requiring Oxygen Therapy
Official title: Safety and Efficacy of Inhaled XW001 (Interleukin 29 Analog for Nebulization) For Hospitalized COVID-19 Patients Requiring Oxygen Therapy: A Multiregional, Randomized, Double-blind, Placebo-controlled Study
Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Difficulty in COVID-19 subject enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-30
Primary completion date: 2022-03-10
Completion date: 2022-04-10
Plan to share individual participant data: NO
Clinical trial NCT04374942: Does Hydroxychloroquine Before & During Patient Exposure Protect Healthcare Workers From Coronavirus?
Official title: Protecting Frontline Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Multi-Site Trial in Toronto, Canada
Acronym: HEROs
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to unproven issues associated with hydroxychloroquine use and safety, further complicated by media and political misinformation which in effect rendered all global studies on HCQ to stop enrolling participants.
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Plan to share individual participant data: YES
IPD sharing description: At the time of completion of the analysis of primary and secondary outcomes, the HEROS Steering Committee will review all applications for use of participant level data and make recommendations.
Clinical trial NCT04155580: A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Official title: A Phase 1, Parallel, Open-Label Study of the Safety and Tolerability, Pharmacokinetics, and Antileukemic Activity of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Sponsor: Astex Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment: 68.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-12
Primary completion date: 2022-01-14
Completion date: 2022-01-14
Plan to share individual participant data: NO
Clinical trial NCT02100696: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
Official title: Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors
Acronym: HICKORY
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 609.0 (ACTUAL)
Number of arms: 6.0
Start date: 2014-05-21
Primary completion date: 2020-04-16
Completion date: 2020-04-16
Baseline population: A total of 609 participants were enrolled into the Induction phase of this study and the entire study. A subset (259) of these participants moved into the Maintenance phase of this study.
Clinical trial NCT05429385: Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
Sponsor: Shanghai Henlius Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor strategy.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-09
Primary completion date: 2021-09-06
Completion date: 2021-09-18
Plan to share individual participant data: NO
Clinical trial NCT01765218: Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
Official title: Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy
Sponsor: University of California, Davis (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was stopped early due to changes in the UC Davis guidelines on who qualified for therapeutic hypothermia and significant difficulty in recruitment of patients following the COVID19 pandemic.
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-02-28
Primary completion date: 2022-01-27
Completion date: 2022-01-27
Limitations and caveats: Study was stopped short of intended recruitment due to difficulty with recruitment during COVID pandemic and changes to the therapeutic hypothermia protocol at our institution.
Clinical trial NCT02282241: Melatonin for Delirium Prophylaxis
Official title: A Randomized Double-Blind Placebo-Controlled Study on the Use of Melatonin for the Prevention of Delirium
Sponsor: University of British Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Project never began
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Clinical trial NCT03550352: Cannabinoids in PLWHIV on Effective ART
Official title: Cannabinoids in People Living With HIV on Effective Antiretroviral Therapy: A Pilot Study to Assess Safety, Tolerability and Effect on Immune Activation
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: expiration of study product; end of study product availability
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-20
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03374852: CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
Official title: A Phase II Open-Label Clinical Trial of CPI-613 in Combination With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer and Good Performance Status
Sponsor: Thomas Jefferson University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI Left institution on 8/6/2018 and study has been final reported with IRB. Never opened to accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-31
Primary completion date: 2019-10-05
Completion date: 2020-10-31
Clinical trial NCT04435717: Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)
Official title: Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19
Acronym: COVITOZ-01
Sponsor: Hospital Universitario Ramon y Cajal (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Futility
Enrollment: 26.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-04
Primary completion date: 2020-11-04
Completion date: 2021-02-10
Plan to share individual participant data: NO
Clinical trial NCT04530136: Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
Official title: Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial in the US
Sponsor: Pharming Technologies B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-30
Primary completion date: 2021-09-07
Completion date: 2021-12-01
Baseline population: Analyzed (FAS/ITT - Interim analysis/Overrunning analysis) in interim analysis phase: rhC1INH plus SOC \[n=23\]; SOC alone \[n=9\]. A subsequent (post hoc) analysis was conducted to include all 38 patients, overrunning analysis phase: rhC1INH plus SOC \[n=27\]; SOC alone \[n=11\].
Plan to share individual participant data: NO
Clinical trial NCT04994002: A Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults With Complex Lymphatic Malformations
Official title: A Phase 1b, Open-Label, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults (Aged 18-31 Years) With Complex Lymphatic Malformations
Sponsor: Avalo Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-03
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT02152956: Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Official title: A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)
Acronym: VOYAGE
Sponsor: MacroGenics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 244.0 (ACTUAL)
Number of arms: 13.0
Start date: 2014-06-09
Primary completion date: 2022-07-05
Completion date: 2022-07-05
Clinical trial NCT04338061: Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
Official title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.
Enrollment: 1124.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-02
Primary completion date: 2023-10-02
Completion date: 2024-03-19
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT03803241: Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases.
Official title: Cd133+ Cell Infusion in Patients With Colorectal Liver Metastases That Are Going to be Submitted to a Major Liver Resection
Acronym: cellcol
Sponsor: Hospital San Carlos, Madrid (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-31
Primary completion date: 2020-12-31
Completion date: 2021-06-30
Clinical trial NCT04335136: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Official title: Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Acronym: APN01-COVID-19
Sponsor: Apeiron Biologics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 185.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2020-12-26
Completion date: 2020-12-26
Baseline population: All randomized patients who received at least 1 dose of investigational medicinal product (IMP).
Clinical trial NCT04525885: A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Month Study to Evaluate the Efficacy and Safety of MK-7264 in Adult Participants With Chronic Cough (PN030)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 161.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-17
Primary completion date: 2022-09-15
Completion date: 2022-09-15
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04927169: InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection (Brazil Cohort)
Official title: Recombinant Human InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic PAtients With COVID-19 Infection - ILIAD 7 Trial Brazil Cohort
Acronym: ILIAD-7-BRA
Sponsor: Revimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: POOR ACCRUAL
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-01
Primary completion date: 2021-12-31
Completion date: 2022-03-30
Plan to share individual participant data: NO
IPD sharing description: Publication
Clinical trial NCT03976648: A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Official title: A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The benefit-risk profile no longer supports continuing the studies
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-18
Primary completion date: 2021-04-13
Completion date: 2021-04-13
Baseline population: The open-label extension (OLE) full analysis set (FAS) was defined as all participants who had at least one intake of investigational product in the OLE study.
Limitations and caveats: The benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.
Plan to share individual participant data: NO
Clinical trial NCT03672097: Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
Official title: Phase IV, Non-comparative, Open Label, Multicenter, 28-Week Switching Study of Prasugrel Maintenance Dose From Clopidogrel in Patients With Acute Coronary Syndrome (ACS) Who Underwent a Percutaneous Coronary Intervention (PCI) in Taiwan
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 204.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-16
Primary completion date: 2020-08-19
Completion date: 2020-08-19
Baseline population: The baseline demographics were reported from the Safety Population.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT03800420: Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis
Sponsor: Bridge Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-22
Primary completion date: 2020-05-18
Completion date: 2020-07-31
Baseline population: subjects who were randomized
Clinical trial NCT04801056: Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19
Official title: A Phase I, First-In-Human, Randomized, Single Ascending Dose Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19
Sponsor: TrueBinding, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Difficulty in patient recruitment and will start again if study population increases to allow study feasibility
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Plan to share individual participant data: NO
Clinical trial NCT04119830: Rintatolimod and Pembrolizumab for the Treatment of Refractory Metastatic or Unresectable Colorectal Cancer
Official title: A Phase IIa Study of Rintatolimod Plus Pembrolizumab in Refractory Metastatic Colorectal Cancer
Sponsor: Roswell Park Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: implementation issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-01
Primary completion date: 2024-02-01
Completion date: 2024-02-01
Clinical trial NCT04630353: A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer
Official title: A Phase 0 Trial of HB-201 for Subjects With Transoral Resectable Human Papillomavirus 16 Positive (HPV 16+) Oropharynx Cancer or With Locally Advanced Cervical Cancer Treated With Chemotherapy and Radiation
Sponsor: Hookipa Biotech GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-28
Primary completion date: 2023-11-28
Completion date: 2023-11-28
Plan to share individual participant data: NO
Clinical trial NCT03566485: Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer
Official title: BRE 17107: A Phase Ib/II Trial of Atezolizumab (an Anti-PD-L1 Monoclonal Antibody) With Cobimetinib (a MEK1/2 Inhibitor) or Idasanutlin (an MDM2 Antagonist) in Metastatic ER+ Breast Cancer
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low accrual/Loss of funding
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-10
Primary completion date: 2020-12-10
Completion date: 2020-12-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04344444: Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease
Official title: Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial
Acronym: RCT
Sponsor: LCMC Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of efficacy data from other studies
Enrollment: 22.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-04-13
Primary completion date: 2021-04-10
Completion date: 2022-01-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04301284: Study of CAD-1883 for Spinocerebellar Ataxia
Official title: Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of CAD-1883 in Adults With Spinocerebellar Ataxia (Synchrony-1)
Acronym: Synchrony-1
Sponsor: Cadent Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: In January 2021 Novartis acquired Cadent Therapeutics. As part of a pipeline reassessment, the Synchrony-1 trial will not proceed as initially scheduled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-30
Primary completion date: 2022-11-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04605991: A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Official title: A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 187.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-04
Primary completion date: 2022-02-04
Completion date: 2022-02-04
Baseline population: All enrolled participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.