chufangao/CTO huggingface dataset:
Clinical trial NCT04315311: Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer
Official title: A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Business Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-06
Primary completion date: 2021-09-22
Completion date: 2021-09-22
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03196921: Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection
Official title: A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
Acronym: ORACLE
Sponsor: Matinas BioPharma Nanotechnologies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Protocol redundancy
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2019-10-01
Completion date: 2020-03-01
Plan to share individual participant data: NO
Clinical trial NCT03062449: Phase IIa L-serine Trial for eAD
Official title: A Phase IIa Proof of Concept, Randomized, Double-blind, Placebo-controlled Study of the Effects of L-serine on Early Stage Alzheimer's Disease Patients
Acronym: LSPI-2
Sponsor: Dartmouth-Hitchcock Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Stability of investigational product could not be established.
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-01
Primary completion date: 2021-07-20
Completion date: 2021-07-20
Baseline population: All study participants are grouped for the baseline measure and reported for all participants collectively. The study was closed by the PI and institution prior to study completion because the stability of the investigational product could not be verified.
Limitations and caveats: The Sponsor-Investigator (PI) and institutional officials determined that the available investigational agent stability data of provided by the product's manufacturer was unsatisfactory. The study was closed by the PI and institution prior to study completion. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time.
Plan to share individual participant data: NO
Clinical trial NCT04060342: GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma
Official title: A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination With an Anti-PD-1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 With Standard of Care or in Combination With an Anti-PD-1 Antibody in Patients With Specified Metastatic Solid Tumors
Sponsor: Gossamer Bio Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.
Enrollment: 61.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-08-13
Primary completion date: 2022-04-11
Completion date: 2022-04-11
Plan to share individual participant data: NO
Clinical trial NCT04605159: A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age
Acronym: GRACE
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.
Enrollment: 11194.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-11-20
Primary completion date: 2023-06-14
Completion date: 2023-06-14
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT04093362: Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Official title: A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3
Acronym: FOENIX-CCA3
Sponsor: Taiho Oncology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to Poor Recruitment
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-01
Primary completion date: 2024-04-22
Completion date: 2024-04-22
Plan to share individual participant data: NO
Clinical trial NCT04156620: Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 527.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-11
Primary completion date: 2022-02-17
Completion date: 2022-12-20
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04881760: A Study of LY3437943 in Participants Who Have Obesity or Are Overweight
Official title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 338.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-05-20
Primary completion date: 2022-05-16
Completion date: 2022-11-22
Baseline population: All randomized 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.
Clinical trial NCT02896192: Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity
Official title: An Open-Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation
Sponsor: Rhythm Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-14
Primary completion date: 2020-05-25
Completion date: 2020-05-25
Baseline population: The Safety Analysis Set (SAS) Population consisted of participants who received any of the study drug injections and had at least one post-dose safety assessment.
Limitations and caveats: There was no planned comparison to a randomized placebo group given the rarity of monogenic POMC deficiency obesity. To provide support in assessing setmelanotide treatment in this open-label single-arm trial design, individual participants were evaluated during a double-blind placebo-controlled withdrawal phase in which participants served as their own control to assess effects on weight and reported hunger scores.
Plan to share individual participant data: NO
Clinical trial NCT04925947: A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors
Official title: Phase II Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Data collected did not support the study endpoints
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-13
Primary completion date: 2023-05-05
Completion date: 2023-05-05
Limitations and caveats: This study was terminated early and participant enrollment was low, resulting in a small sample size (N=4). Having a small sample size may reduce statistical reliability and generalizability of results.
Plan to share individual participant data: NO
Clinical trial NCT04999605: A Study of AK112 Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer
Official title: Phase Ib/II Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody (AK112) Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer
Sponsor: Akeso (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Too low inclusion rate
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-24
Primary completion date: 2022-06-10
Completion date: 2022-06-10
Plan to share individual participant data: NO
Clinical trial NCT03954314: DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Official title: Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) Study
Acronym: DEPOSITION
Sponsor: Population Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Upon the Data Safety Monitoring Board review of the interim analysis (75% of participants have finished their follow-up) on November 17, 2023, they made a recommendation to stop recruitment into the trial.
Enrollment: 3242.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-17
Primary completion date: 2023-11-28
Completion date: 2023-11-28
Plan to share individual participant data: NO
Clinical trial NCT05033912: A Study of CST-2032 in Subjects With Cognitive Impairment
Official title: An Open-Label Ascending Single-Dose, and Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CST-2032 in Healthy Volunteers and Subjects With Mild Cognitive Impairment or Parkinson's Disease
Sponsor: CuraSen Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-31
Primary completion date: 2022-03-31
Completion date: 2022-05-31
Plan to share individual participant data: NO
Clinical trial NCT03326583: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Official title: The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of End Stage Renal Disease Patients With Hyperkalemia
Sponsor: George Washington University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-01
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT01640301: Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant
Official title: Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Patients With Relapsed AML
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow accrual.
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-12-06
Primary completion date: 2020-03-20
Completion date: 2020-03-20
Clinical trial NCT04574362: Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
Official title: BHV3000-310: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1648.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-22
Primary completion date: 2021-11-24
Completion date: 2021-12-16
Baseline population: Baseline analysis population included all treated participants (all enrolled participants who took either of the study drug).
Clinical trial NCT05337774: Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
Official title: Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
Sponsor: Life Molecular Imaging SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: study funding period ended March 2022
Enrollment: 18.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-07
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Plan to share individual participant data: NO
Clinical trial NCT05360238: Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL
Official title: A Phase 1/2, Open Label, Multicenter Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory CD20+ B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Sponsor: Mustang Bio (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 20.0 (ACTUAL)
Number of arms: 7.0
Start date: 2022-05-24
Primary completion date: 2024-04-12
Completion date: 2024-04-12
Clinical trial NCT04233814: Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ph 1a, First-in-Man, Single Ascending Dose & Multiple Ascending Dose Safety, Tolerability and PK Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult Subjects
Sponsor: Lung Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 71.0 (ACTUAL)
Number of arms: 9.0
Start date: 2020-01-20
Primary completion date: 2021-12-23
Completion date: 2021-12-23
Clinical trial NCT03831854: Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Official title: The Role of Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine Use
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-24
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
IPD sharing description: There is no plan to make subjects data available to outside researchers
Clinical trial NCT05435339: A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
Official title: First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors
Sponsor: Genmab (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to strategic evaluation of GEN1053 within the context of Genmab's portfolio
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-10-04
Primary completion date: 2024-05-24
Completion date: 2024-05-24
Plan to share individual participant data: NO
Clinical trial NCT01573169: PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Official title: PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Acronym: PREVENTIHS
Sponsor: University Of Perugia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The trial has been terminated prematurely after the randomization of 73 patients due to a lack of funding.
Enrollment: 73.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-05-31
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Clinical trial NCT04016116: Dual PD-1 and JAK2 Inhibition in Hematological Malignancies
Official title: Study of PD-1 Inhibition With Pemrolizumab Alore or Combined With JAK 2 Inhibition in Myeloproliferative Neoplasm and Hodgkin's Lymphoma
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI left the institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-31
Primary completion date: 2020-12-31
Completion date: 2021-12-31
Clinical trial NCT03728933: A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
Official title: A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision; Not a safety decision
Enrollment: 23.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-20
Primary completion date: 2022-07-25
Completion date: 2022-07-25
Baseline population: The Randomized Set consisted of all participants from the Enrolled Set who have been randomized.
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT04577781: A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Acronym: LADYBUG
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-12
Primary completion date: 2021-03-26
Completion date: 2021-04-07
Baseline population: Safety analysis set (SAS) consisted of all participants who received at least 1 dose of investigational product.
Plan to share individual participant data: NO
Clinical trial NCT03387761: Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy
Official title: Phase 1B Study to Assess Safety and Efficacy of Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO)
Acronym: NABUCCO
Sponsor: The Netherlands Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 54.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-15
Primary completion date: 2021-07-19
Completion date: 2021-09-13
Plan to share individual participant data: NO