chufangao/CTO huggingface dataset:
Clinical trial NCT03052517: Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
Official title: A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Company Decision
Enrollment: 2538.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-03-21
Primary completion date: 2020-02-19
Completion date: 2020-03-16
Baseline population: SAF: All patients who received at least one dose of study drug during this study.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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 NCT03888807: Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
Official title: The Effect of Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
Sponsor: Sport and Spine Rehab Clinical Research Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Decided not go move forward with this population as recruitment was difficult
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-01
Primary completion date: 2024-07-31
Completion date: 2024-07-31
Plan to share individual participant data: NO
Clinical trial NCT02022293: Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis
Official title: Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Enrollment target could not be achieved.
Enrollment: 324.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2017-01-31
Primary completion date: 2023-12-31
Completion date: 2024-01-31
Clinical trial NCT04309656: Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
Official title: An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid
Sponsor: Global Alliance for TB Drug Development (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-14
Primary completion date: 2020-02-28
Completion date: 2020-02-28
Clinical trial NCT03622580: A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
Official title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 940.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-05
Primary completion date: 2020-10-20
Completion date: 2021-09-03
Baseline population: The overall number of baseline participants (940) comprises the Intent-to-Treat (ITT) Population, which includes all global participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Limitations and caveats: All secondary outcome measures were unpowered for statistical analysis, and the results should be interpreted with caution.
Clinical trial NCT01363128: Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Official title: Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 1.0
Start date: 2011-07-12
Primary completion date: 2020-04-08
Completion date: 2020-04-08
Clinical trial NCT04588207: Urea for Chronic Hyponatremia
Official title: Urea for Chronic Hyponatremia: A Pilot Study
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unable to recruit participants
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-28
Primary completion date: 2022-09-29
Completion date: 2022-09-29
Limitations and caveats: Study was terminated because of inability to recruit. Only two participants were recruited of the estimated 30 participants.
Plan to share individual participant data: YES
IPD sharing description: The investigators will share all collected IPD
IPD time frame: 12 months after publication of primary manuscript
IPD access criteria: Request in writing addressed to the principal investigator
Clinical trial NCT05702788: Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia
Acronym: COVID-19
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor R\&D Strategy Adjustment
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-09-30
Primary completion date: 2024-04-23
Completion date: 2024-04-23
Plan to share individual participant data: NO
Clinical trial NCT04186377: Application of S26E for Diabetic Foot Ulcer Healing
Official title: A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing
Sponsor: National and Kapodistrian University of Athens (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inability to recruit subjects
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-15
Primary completion date: 2021-11-29
Completion date: 2021-11-29
Plan to share individual participant data: NO
Clinical trial NCT04363437: COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19
Official title: COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study)
Acronym: COMBATCOVID19
Sponsor: Maimonides Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Stopped due to widespread corticosteroid use in 2020 for COVID infection, which confounds and likely supercedes the effect of colchicine.
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-26
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Plan to share individual participant data: NO
Clinical trial NCT02432066: Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Official title: Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was not started and participants were not enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-29
Primary completion date: 2018-12-29
Completion date: 2020-12-29
Clinical trial NCT04789330: Norepinephrine vs Phenylephrine During General Anesthesia
Official title: The Choice of Vasopressor for Treating Hypotension During General Anesthesia: a Pilot Pragmatic Cluster Cross-over Randomized Trial (the VEGA-1 Trial)
Acronym: VEGA-1
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 2000.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-01
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Plan to share individual participant data: NO
Clinical trial NCT03566823: Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Acronym: CARMEN CD 306
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Enrollment: 34.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-17
Primary completion date: 2020-08-18
Completion date: 2020-08-18
Baseline population: The safety set consisted of all participants who had received at least 1 dose of investigational product (IP).
Limitations and caveats: The study was terminated as the sponsor discontinued the ontamalimab clinical trial program in ulcerative colitis and CD for reasons unrelated to safety.
Clinical trial NCT04571580: Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention
Official title: Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction
Acronym: RECOVERII
Sponsor: Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study enrollment is slow due to the pandemic.
Enrollment: 36.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-07-01
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Clinical trial NCT03724409: Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases
Official title: Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Pandemic
Enrollment: 3.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-10-11
Primary completion date: 2021-03-21
Completion date: 2023-05-23
Plan to share individual participant data: YES
IPD sharing description: Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.
IPD time frame: Considered upon request.
IPD access criteria: Contact study PI regarding data sharing. A non-disclosure agreement may be required between institutions dependent upon the data requested.
Clinical trial NCT04592419: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Acronym: BEACON
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 568.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-25
Primary completion date: 2022-06-10
Completion date: 2023-01-19
Baseline population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
Plan to share individual participant data: NO
Clinical trial NCT03031782: Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
Official title: A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-23
Primary completion date: 2020-10-07
Completion date: 2020-11-09
Baseline population: Safety Set included subjects who received any treatment. TP1 = 86, TP2 = 75
Plan to share individual participant data: UNDECIDED
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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 NCT04912856: An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
Official title: An Open-Label Extension of the Study XEN496 in Children With KCNQ2 Developmental and Epileptic Encephalopathy
Acronym: EPIK-OLE
Sponsor: Xenon Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision; not a safety decision
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-17
Primary completion date: 2023-11-17
Completion date: 2023-11-17
Clinical trial NCT03971734: Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas
Official title: Determining the Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]
Enrollment: 7.0 (ACTUAL)
Number of arms: 7.0
Start date: 2019-12-06
Primary completion date: 2022-04-30
Completion date: 2023-10-02
Plan to share individual participant data: NO
Clinical trial NCT05247307: Efficacy of the Infusion of Donor Plasma in COVID-19 Infection
Official title: Clinical Efficacy of the Infusion of Donor Plasma, Convalescent From SARS-CoV-2 Infection, to Patients With Recent Infection.
Sponsor: Hospital Galdakao-Usansolo (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of efficacy of treatment tested
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: YES
IPD sharing description: Upon request
IPD time frame: Around this year 2022
IPD access criteria: Contact with principal investigator
Clinical trial NCT03993639: KRN125 for Mobilization of Hematopoietic Stem Cells
Official title: A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-28
Primary completion date: 2020-07-21
Completion date: 2020-08-28
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04891250: The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19
Official title: The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19
Acronym: ZIT
Sponsor: Centre for Infectious Disease Research in Zambia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Insufficient funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-31
Primary completion date: 2021-12-31
Completion date: 2022-06-30
Clinical trial NCT03692871: A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2409.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-14
Primary completion date: 2021-03-26
Completion date: 2021-03-26
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03626376: Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
Official title: A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Unable to enroll participants
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-10
Primary completion date: 2021-03-02
Completion date: 2022-03-02
Plan to share individual participant data: NO
Clinical trial NCT04693637: Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Official title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Acronym: Prevent
Sponsor: AlloVir (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-15
Primary completion date: 2023-01-19
Completion date: 2023-01-19
Baseline population: Analysis Population will include all patients who received posoleucel.
Plan to share individual participant data: NO
Clinical trial NCT05383560: Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults
Official title: Phase 2, Randomized, Observer-Blind, Investigator-Initiated, Collaborative Study to Evaluate the Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults
Acronym: SH-MO-214
Sponsor: Sheba Medical Center (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 179.0 (ACTUAL)
Number of arms: 5.0
Start date: 2022-09-05
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: YES
IPD sharing description: Unidentified data will be available after publication of the results.
IPD time frame: will be available upon publication of results
IPD access criteria: Upon request. Requires collaborator's approval as well.
Clinical trial NCT04429503: Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Official title: A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
Acronym: PHOTON
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 660.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-29
Primary completion date: 2022-05-30
Completion date: 2024-06-18
Baseline population: Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized). Only one study eye per participant was analyzed within the study.
Plan to share individual participant data: YES
IPD sharing description: All IPD that underlie results in a publication.
IPD time frame: Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
IPD access criteria: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
Clinical trial NCT02864251: A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
Official title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy
Acronym: CheckMate722
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 367.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-03-17
Primary completion date: 2022-01-20
Completion date: 2022-10-17
Clinical trial NCT04446377: A Study of LAM-002A for the Prevention of Progression of COVID-19
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of LAM-002A for the Prevention of Progression of COVID-19
Sponsor: OrphAI Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 142.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-15
Primary completion date: 2021-03-24
Completion date: 2021-04-19
Baseline population: The intention-to-treat (ITT) population included all participants randomized according to their initial randomized assignment regardless of the treatment actually received.
Limitations and caveats: The study was potentially limited in its ability to discern a benefit of LAM-002A on viral and clinical endpoints due to the number of participants enrolled, the low baseline viral loads, and the short (4-day) duration of viral load evaluation.
Plan to share individual participant data: NO
Clinical trial NCT05298332: Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects
Official title: A Phase 1, Open-Label, 3-Cohort, Parallel, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose ATI-2173 50 mg in Healthy Japanese, Chinese, and Non-Asian Subjects
Sponsor: Antios Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated by the Sponsor
Enrollment: 37.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-29
Primary completion date: 2022-08-22
Completion date: 2022-08-22