chufangao/CTO huggingface dataset:
Clinical trial NCT03620162: A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Official title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 900.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-10-18
Primary completion date: 2020-12-14
Completion date: 2020-12-14
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02658812: Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery
Official title: A Phase II Study Using Talimogene Laherparepvec for Inflammatory Breast Cancer (IBC) or Non-IBC Patients With Inoperable Local Recurrence
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Per PI
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-01
Primary completion date: 2021-12-01
Completion date: 2021-12-01
Clinical trial NCT02933697: Compare Apixaban and Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD)
Official title: A Safety Study Assessing Oral Anticoagulation With Apixaban Versus Vitamin-K Antagonists in Patients With Atrial Fibrillation (AF) and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment
Acronym: AXADIA
Sponsor: Atrial Fibrillation Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-20
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT04882176: A Clinical Study Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours
Official title: A Phase I/II, First-in-Human, Open-Label, Dose-Escalation and Dose-Extension Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours
Sponsor: LaNova Medicines Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Not meeting expected endpoints
Enrollment: 18.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-05-20
Primary completion date: 2023-02-07
Completion date: 2023-07-19
Plan to share individual participant data: NO
Clinical trial NCT03829449: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
Official title: CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
Acronym: CONSERVE
Sponsor: AKARI Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The early termination of this study is a business decision, Akari have made the decision to close their global Phase III PNH program. The decision was not related to any efficacy, safety or clinical concerns regarding Coversin/rVA576.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-13
Primary completion date: 2020-08-29
Completion date: 2020-08-29
Plan to share individual participant data: NO
Clinical trial NCT04526912: Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
Official title: A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection
Acronym: ALI
Sponsor: Viela Bio (acquired by Horizon Therapeutics) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study met predefined futility criteria for efficacy endpoints.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-28
Primary completion date: 2021-04-08
Completion date: 2021-05-19
Plan to share individual participant data: NO
Clinical trial NCT03980938: Within Subject Crossover Study of Cognitive Effects of Neflamapimod in Early-Stage Huntington Disease
Official title: A Double-Blind, Placebo-Controlled Two-Period 10-Week Treatment Within-Subject Crossover Study Of Cognitive Effects Of Neflamapimod in Early-Stage Huntington Disease (HD)
Sponsor: EIP Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the long delay because of COVID-19 and results from another study suggesting a higher dose may be more beneficial, EIP Pharma decided on October 15th, 2020, to end the trial prematurely.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-08
Primary completion date: 2020-10-15
Completion date: 2020-10-15
Limitations and caveats: Due COVID-19 pandemic all clinical research in the UK was halted in March 2020. Sponsor ultimately elected to terminate the study on 15 October 2020. As only one subject completed both periods of the crossover, the only efficacy analyses compared outcomes in subjects receiving neflamapimod (N=7) during Treatment period 1 to those receiving placebo during that period (N=8); i.e., an inter-subject group comparison, rather than the within-subject comparison for which the study was powered.
Plan to share individual participant data: NO
Clinical trial NCT03604445: This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)
Official title: An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 37.0 (ACTUAL)
Number of arms: 9.0
Start date: 2018-08-08
Primary completion date: 2022-07-27
Completion date: 2022-07-27
Baseline population: Treated Set (TS): includes all patients who received at least one infusion of BI 905677.
Limitations and caveats: Recruitment into Schedule B was planned start after the maximum tolerated dose of Schedule A was reached. Study was terminated prematurely due to sponsor decision before Schedule B starting. The planned Schedule B part was not held.
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/datasharing
Clinical trial NCT04889040: Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
Official title: A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19
Acronym: MORNINGSKY
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.
Enrollment: 216.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-28
Primary completion date: 2021-12-02
Completion date: 2021-12-02
Limitations and caveats: The study was terminated with only 16% of the planned sample size.
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)
Clinical trial NCT03439033: Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
Official title: A Phase 2 Comparison Study of 68Ga-PSMA-HBED-CC Positron Emission Tomography (PET)/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study Drug was FDA approved Summer 2021
Enrollment: 273.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-03
Primary completion date: 2021-05-05
Completion date: 2021-05-05
Limitations and caveats: One limitation is the small number of cases available for specificity analysis resulting in a negligible sample size of patients who had a true negative reference. Another limitation is multiple patients sought care at other institutions. As a result, information was not complete for several patients. Only a small number of the subjects had 2-year follow-up or underwent confirmatory biopsy, which introduces the possibility of selection bias.
Plan to share individual participant data: NO
Clinical trial NCT04280055: Prophylactic Effects of Psilocybin on Chronic Cluster Headache
Official title: Prophylactic Effects of Psilocybin on Chronic Cluster Headache: an Open-label Clinical Trial and Neuroimaging Study
Acronym: EPOCH
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Not possible to achieve the anticipated no. of patients due to Covid-19 pandemic
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-21
Primary completion date: 2020-11-01
Completion date: 2022-06-01
Plan to share individual participant data: YES
IPD sharing description: Via database of Center for integrated Molecular Brain Imaging (CIMBI) data will be available for neuroscience research community contingent on approval by scientific board.
Clinical trial NCT04909723: Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
Official title: Phase 1-2a Safety, Tolerability, and Pharmacodynamics Controlled Study of NOV-001 in Healthy Volunteers and Patients With Enteric Hyperoxaluria
Sponsor: Novome Biotechnologies Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision to discontinue study.
Enrollment: 153.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-06-02
Primary completion date: 2022-11-30
Completion date: 2023-04-06
Plan to share individual participant data: NO
Clinical trial NCT00789165: Empiric Quinidine for Asymptomatic Brugada Syndrome
Official title: A Prospective Trial Of Empiric Quinidine Therapy For Asymptomatic Brugada Syndrome.
Sponsor: International Registry of Asymptomatic Brugada Syndrome (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2009-12-31
Primary completion date: 2020-02-29
Completion date: 2020-12-31
Clinical trial NCT03857256: Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Compare The Efficacy And Safety Of High-Medium Molecular Weight Beta-Glucan As Add-On To Statin Therapy In Subjects With Hyperlipidemia.
Acronym: BetAvena
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 263.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-05-31
Primary completion date: 2021-08-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04581915: PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
Official title: A Pragmatic, Individually Randomised, Double-blind, Placebo-controlled Trial of Triazavirin (TZV) for the Treatment of Mild-moderate SARS-CoV-2 Infection A Phase II and III Clinical Trial
Acronym: PHRUCov01
Sponsor: Wits Health Consortium (Pty) Ltd (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: DSMB report
Enrollment: 74.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-08
Primary completion date: 2021-04-20
Completion date: 2021-04-20
Plan to share individual participant data: NO
Clinical trial NCT03854500: The Norwegian Tenecteplase Stroke Trial 2
Official title: A Randomised Trial of Tenecteplase vs. Alteplase in Acute Ischemic Stroke
Acronym: NOR-TEST 2
Sponsor: Haukeland University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Per protocol safety analysis 200 patients showed a significant difference in bleeding rates between the two drug groups.
Enrollment: 201.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-28
Primary completion date: 2021-09-30
Completion date: 2021-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04002310: A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Intravitreal Doses and Multiple Intravitreal Dosing of BI 754132 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized, Uncontrolled).
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The trial was discontinued in the interests of patients considering benefit/risk balance.
Enrollment: 18.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-07-26
Primary completion date: 2022-08-09
Completion date: 2022-08-09
Baseline population: Treated Set (TS): The TS consisted of all patients who were treated with at least 1 dose of BI 754132.
Limitations and caveats: The trial was terminated prematurely based on a negative benefit-risk assessment, which was based on the analysis of the safety data during the trial.
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/datasharing
Clinical trial NCT05315479: Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Official title: A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Sponsor: Baudax Bio (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Anjeso (N1539) NDA Withdrawn
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-24
Primary completion date: 2022-07-07
Completion date: 2022-07-07
Plan to share individual participant data: NO
Clinical trial NCT05321979: Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Official title: Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Sponsor: Medy-Tox (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 253.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-07
Primary completion date: 2023-05-30
Completion date: 2023-05-30
Clinical trial NCT05309902: A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval
Official title: A Phase 1, Double-Blinded, Placebo- and Active-Controlled, Randomized Study to Investigate the Potential of Soticlestat to Prolong the QTc Interval in Healthy Adult Participants
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study not needed
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-10-11
Primary completion date: 2022-12-06
Completion date: 2022-12-06
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 NCT04140396: Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Official title: A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of personnel and lack of funding for the study drug
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-10
Primary completion date: 2020-11-09
Completion date: 2020-11-09
Limitations and caveats: This study did not meet its planned enrollment size and did not achieve statistical significance as prespecified in the study protocol.
Clinical trial NCT05182047: A Study of Butamirate Citrate Syrup Versus (vs) Sinecod Syrup (Vanilla) in Adult Healthy Study Volunteers
Official title: A Randomized, Open, Crossover, Single Dose, Bioequivalence Study of a Novel Medication Butamirate Citrate Syrup 1.5 mg/mL (McNeil Iberica S.L.U., Spain) vs. Sinecod Syrup (Vanilla) 1.5 mg/mL (GSK Consumer Healthcare S.A., Switzerland), in Adult Healthy Study Volunteers
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-18
Primary completion date: 2022-05-05
Completion date: 2022-05-05
Plan to share individual participant data: YES
IPD sharing description: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Clinical trial NCT03170661: Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
Official title: Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery
Acronym: BLISS4
Sponsor: Leiden University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-14
Primary completion date: 2020-04-01
Completion date: 2020-06-01
Clinical trial NCT04995536: CpG-STAT3 siRNA CAS3/SS3 and Localized Radiation Therapy for the Treatment of Relapsed/Refractory B-Cell NHL
Official title: A Phase I Study of Intratumoral Injections of CpG-STAT3 siRNA (CAS3/SS3) in Combination With Local Radiation in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL)
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: no accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-27
Primary completion date: 2024-01-04
Completion date: 2024-01-04
Clinical trial NCT04556760: Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes
Official title: A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 46.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-11-26
Primary completion date: 2021-06-09
Completion date: 2021-06-09
Baseline population: Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.
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 deidentified 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 NCT03563222: Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Official title: Prospective, Randomized (1:1), Double-Blind, Parallel-Group, Active-Controlled, Multicenter Study to Compare Safety and Efficacy of Smoflipid to Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Requiring Parenteral Nutrition for at Least 90 Days and up to 1 Year
Sponsor: Fresenius Kabi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Prematurely stopped in agreement with authorities (FDA)
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-18
Primary completion date: 2020-11-12
Completion date: 2022-07-08
Baseline population: Study was prematurely terminated
Limitations and caveats: The study was released from postmarketing requirement and the product received marketing authorization approval from the U.S. Food \& Drug Administration. Therefore, the study was early terminated after treatment of a single patient.