chufangao/CTO huggingface dataset:
Clinical trial NCT02514382: Wild-Type Reovirus, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1b Study of REOLYSIN® (Reovirus Serotype 3 - Dearing Strain) Combined With Standard Doses of Bortezomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-21
Primary completion date: 2022-04-19
Completion date: 2022-04-19
Clinical trial NCT03714880: Cervical Preparation With Mifepristone Prior to Osmotic Dilators
Official title: Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
Sponsor: University of California, Davis (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow recruitment compounded by COVID-19
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-26
Primary completion date: 2021-02-26
Completion date: 2021-02-26
Clinical trial NCT04834128: A Phase II Safety and Tolerability Study of TCB008 in Patients With COVID-19
Official title: A Phase II Safety and Tolerability, Inter-patient Pre-defined Dose Study of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (TCB008) in Patients Diagnosed With COVID-19
Sponsor: TC Biopharm (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was stopped because of the current status of the COVID-19 epidemic in the United Kingdom, and also because the trial involved parenterally administered IMP and a period of inpatient care and extensive outpatient visits and investigations.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-13
Primary completion date: 2022-04-13
Completion date: 2022-04-13
Clinical trial NCT04109885: Paracervical Injection for Headache in the Emergency Department
Official title: Intramuscular Paracervical Injection for Headache in the Emergency Department: A Randomized Controlled Trial
Sponsor: Albert Einstein Healthcare Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient recruitment.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2024-01-30
Completion date: 2024-01-30
Plan to share individual participant data: NO
Clinical trial NCT05241613: A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer
Official title: A Phase I Study to Evaluate Safety, Tolerability, PK, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC176 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Progressed on at Least Two Prior Systemic Therapies
Sponsor: Accutar Biotechnology Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-16
Primary completion date: 2024-03-05
Completion date: 2024-03-05
Plan to share individual participant data: NO
Clinical trial NCT03287908: A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination With Pomalidomide, With and Without Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: business decision, not safety reasons.
Enrollment: 174.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-11-13
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT02758665: Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
Official title: A Prospective, Open-label, Multicentre Phase-II Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Physically Fit or Unfit Patients With Previously Untreated Chronic Lymphocytic Leukemia (Cll) With tp53 Deletion (17p-) and/or Mutation
Acronym: CLL2-GiVe
Sponsor: University of Ulm (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-09-30
Primary completion date: 2022-01-31
Completion date: 2022-03-31
Plan to share individual participant data: YES
Clinical trial NCT03059615: A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS
Official title: A Phase 2a, Open-Label, Two Stage Study: Stage A: Dose-Range Finder Study to Assess the Safety and Efficacy of Two Doses of Nerofe and Two Doses of Nerofe in Combination With Doxorubicin in Subjects With Acute Myelogenous Leukemia or High Risk Myelodysplastic Syndrome (AML/High Risk MDS). Stage B: Dose Confirmation Study to Assess the Safety and Efficacy of Nerofe or Nerofe in Combination With Doxorubicin in Subjects With AML/ High Risk MDS
Sponsor: Immune System Key Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No recruitment since initiation
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-25
Primary completion date: 2020-07-26
Completion date: 2020-07-26
Plan to share individual participant data: NO
Clinical trial NCT04200352: A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy
Official title: An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint
Enrollment: 44.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-04
Primary completion date: 2023-02-14
Completion date: 2023-02-14
Baseline population: The intent-to-treat (ITT) analysis set included all enrolled participants, regardless of whether or not a participant took any TEV-50717.
Limitations and caveats: The study was terminated early due to failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)
Clinical trial NCT04107675: A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
Official title: A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation
Acronym: BOSTON-4
Sponsor: Zambon SpA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the low number of patients recruited and the slow enrollment pace of patients, on 18 March 2022, the sponsor decided to terminate the BOSTON-4 safety and tolerability trial ahead of time.
Enrollment: 6.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-11
Primary completion date: 2022-06-16
Completion date: 2022-12-15
Baseline population: The Safety Analysis Set (SAF) was defined as all randomized patients who had received a partial dose of IMP at least once.
Limitations and caveats: From the beginning of the trial, only 6 patients were enrolled. Due to the low number of patients recruited so far and the slow enrolment pace of patients, on 18 March 2022, the sponsor decided to terminate the BOSTON-4 safety and tolerability trial early. This decision was made after the Sponsor performed a careful and due diligent analysis of the current study status and considered the impact of the coronavirus disease 2019 (COVID-19) pandemic on-site activities.
Plan to share individual participant data: NO
Clinical trial NCT04739384: Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg in Elderly Patients With ACS
Official title: Platelet Inhibition With Ticagrelor 60 mg Versus Ticagrelor 90 mg Twice Daily in Elderly Patients With Acute Coronary Syndrome (ACS)
Acronym: PlinytheElder
Sponsor: Federico II University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-01
Primary completion date: 2022-06-20
Completion date: 2022-06-20
Plan to share individual participant data: NO
Clinical trial NCT04082858: Ketamine Interleaved With Electroconvulsive Therapy for Depression
Official title: Ketamine Interleaved With Electroconvulsive Therapy for Depression, A Pragmatic Randomised Controlled Pilot Trial
Sponsor: St Patrick's Hospital, Ireland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Inadequate recruitment due to COVID-19
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2020-06-03
Completion date: 2020-06-03
Plan to share individual participant data: NO
Clinical trial NCT02865850: Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Official title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)
Sponsor: Akebia Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 369.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-31
Primary completion date: 2020-01-31
Completion date: 2020-03-30
Plan to share individual participant data: NO
Clinical trial NCT01940341: Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 426.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-09-12
Primary completion date: 2015-09-30
Completion date: 2022-08-31
Baseline population: Safety Analysis Set: Participants who received at least 1 dose of study drugs.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT05633745: A Study to Assess NEU-723 in Healthy Participants
Official title: A Phase 1, Single and Multiple Ascending Dose Study of NEU-723 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects
Sponsor: Neuron23 Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-30
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Clinical trial NCT03682601: Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
Official title: Sinecatechins Ointment, a Botanical Drug Derived From Green Tea, for the Treatment of Significant to Severe Secondary Provoked Vestibulodynia in Sexually Active, Post-Menopausal Women With Vulvovaginal Atrophy
Sponsor: GTO Pharmaceutical, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: pandemic
Enrollment: 32.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-30
Primary completion date: 2021-02-12
Completion date: 2021-02-13
Limitations and caveats: Early termination due to Coronavirus disease (COVID-19) pandemic.
Plan to share individual participant data: NO
Clinical trial NCT03600467: Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive Glioblastoma
Official title: A Single-arm, Open-label, Signal-seeking, Phase IIa Trial of the Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive GBM
Acronym: START
Sponsor: St Vincent's Hospital, Sydney (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-13
Primary completion date: 2021-02-28
Completion date: 2021-02-28
Plan to share individual participant data: NO
Clinical trial NCT03810105: A Study of Olaparib and Durvalumab in Prostate Cancer
Official title: A Phase II Study of Olaparib and Durvalumab in Men With Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to low accrual
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-07
Primary completion date: 2023-07-06
Completion date: 2023-07-06
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 NCT02849457: Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Official title: Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-12-31
Primary completion date: 2023-04-26
Completion date: 2023-05-05
Limitations and caveats: COVID-19 impacted one of the secondary endpoints (ADOS2) because of the requirement for facemasks during the assessment which would invalidate the ADOS2. Therefore this secondary outcome measure abandoned.
Plan to share individual participant data: YES
IPD sharing description: De-identified data will be shared with National Database for Autism Research (NDAR)
Clinical trial NCT03265574: PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?
Official title: Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma: a Phase 3 Randomised, Open Label, Blinded Endpoint, Superiority Trial of Enalapril to Prevent Anthracycline-induced CardioToxicity
Acronym: PROACT
Sponsor: South Tees Hospitals NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 111.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-04
Primary completion date: 2023-08-04
Completion date: 2023-08-04
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03851250: A Study of MRx-4DP0004 in Asthma
Official title: A First in Human, Double-blind, Placebo-controlled, Multicentre Phase I/II Study to Evaluate the Safety, Tolerability and Immune Modulatory Effects of MRx-4DP0004 in Participants Taking Long-term Control Medication for Their Asthma
Sponsor: 4D pharma plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor insolvency
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-04
Primary completion date: 2023-04-26
Completion date: 2023-04-26
Plan to share individual participant data: NO
Clinical trial NCT02322593: Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Official title: An Open-label Randomized Multi-center Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
Acronym: SOLAR
Sponsor: Taiho Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 711.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-12-31
Primary completion date: 2019-02-28
Completion date: 2020-05-31
Baseline population: Full Analysis Set (FAS)：Patients in AT population who have advanced gastric cancer at randomization.
Clinical trial NCT05619172: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
Official title: A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer
Sponsor: Sotio Biotech Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to lack of efficacy shown at the time of the interim analysis.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-22
Primary completion date: 2024-03-06
Completion date: 2024-06-05
Plan to share individual participant data: NO
Clinical trial NCT03058614: Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient Management
Official title: Contrast-enhanced Ultrasound Versus CT Scan for Kidney Stone Patient
Acronym: CEUS
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The research team submitted grants over the course of several years to gain funds to support this research but were unsuccessful in securing the funds. The research team will now focus on other funded studies.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-30
Primary completion date: 2022-05-02
Completion date: 2022-05-02
Plan to share individual participant data: NO
Clinical trial NCT04343001: Coronavirus Response - Active Support for Hospitalised Covid-19 Patients
Official title: Aspirin, Losartan and Simvastatin in Hospitalised COVID-19 Patients: a Multinational Randomised Open-label Factorial Trial
Acronym: CRASH-19
Sponsor: London School of Hygiene and Tropical Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Grant not obtained
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-10-31
Primary completion date: 2021-04-30
Completion date: 2021-08-31
Plan to share individual participant data: YES
IPD sharing description: As many sites will contribute to this trial, individual sites cannot restrict the publication of the manuscript relating to the outcomes of this trial. All anonymised data from this trial will be made freely available on our data sharing site: http://freebird.lshtm.ac.uk.
IPD time frame: Within 6 months or sooner of publication
IPD access criteria: Log-in required for the sole purpose to monitor data download.
Clinical trial NCT03644264: PA21 Safety and Efficacy in Adult Chinese Subjects
Official title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 and Sevelamer Carbonate (Renvela®) in Chinese CKD Patients With Hyperphosphataemia
Sponsor: Vifor Fresenius Medical Care Renal Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 286.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-31
Primary completion date: 2020-08-21
Completion date: 2020-08-21
Plan to share individual participant data: NO
Clinical trial NCT05349435: A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate
Official title: A Phase 1, Randomised, Open-Label, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of PBI-4050 Compared to Sodium Phenylbutyrate in Healthy Subjects
Sponsor: Liminal BioSciences Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor has decided to discontinue development of fezegepras based on initial pharmacokinetic results
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-13
Primary completion date: 2022-06-30
Completion date: 2022-06-30