chufangao/CTO huggingface dataset:
Clinical trial NCT03810313: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
Official title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
Acronym: RAVEN
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated by sponsor due to increased incidences of adverse events of special interest (intraocular inflammation including retinal vasculitis, and retinal vascular occlusion), in patients dosed every 4 weeks beyond 3 initial doses.
Enrollment: 493.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-03
Primary completion date: 2021-07-26
Completion date: 2021-07-26
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 NCT05545683: Safety and Immunogenicity of Inactivated Heterologous Booster Vaccination
Official title: Open-Label Phase 3 Clinical Study to Investigate Safety and Immunogenicity of a Single VLA2001 Booster Vaccination in Volunteers Aged ≥18 Years, After Priming With Another Inactivated COVID-19 Vaccine
Sponsor: Centro de Estudios en Infectogía Pediatrica (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: funding was suspended
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-01
Primary completion date: 2023-03-30
Completion date: 2024-06-30
Plan to share individual participant data: NO
Clinical trial NCT03621982: Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
Official title: A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors
Sponsor: ADC Therapeutics S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Cami in combination with pembrolizumab in solid tumors showed signals of immunomodulatory activity. However, the signals were insufficiently compelling at the tested dose/schedule to justify continuation of the study.
Enrollment: 78.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-09
Primary completion date: 2022-12-14
Completion date: 2022-12-14
Plan to share individual participant data: NO
Clinical trial NCT04116359: Testing of the Addition of a New Anti-cancer Drug, Molibresib, to Chemotherapy Treatment (Etoposide and Cisplatin) for Patients With NUT Carcinoma
Official title: A Phase 1/2 Study of the Bromodomain Inhibitor Molibresib in Combination With Etoposide/Platinum in Patients With NUT Carcinoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Other - Protocol moved to Disapproved
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-18
Primary completion date: 2020-09-18
Completion date: 2020-09-18
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT03548064: A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
Official title: A Phase 1 Double-Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Double Mutant Heat-Labile Toxin LTR192G/L211A (dmLT) From Enterotoxigenic Escherichia Coli (ETEC) by Oral, Sublingual, or Intradermal Vaccination in Adults Residing in an Endemic Area
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: COVID 19 cases at the site
Enrollment: 75.0 (ACTUAL)
Number of arms: 9.0
Start date: 2019-03-10
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT02465437: Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis
Sponsor: Corbus Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor terminated open-label extension
Enrollment: 42.0 (ACTUAL)
Number of arms: 5.0
Start date: 2015-08-31
Primary completion date: 2016-10-31
Completion date: 2020-12-11
Clinical trial NCT04146935: Examining the Effect of Burosumab on Muscle Function
Official title: Examining the Effect of Burosumab on Muscle Function Using MR Spectroscopy
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-13
Primary completion date: 2022-08-25
Completion date: 2022-08-25
Plan to share individual participant data: NO
Clinical trial NCT04633187: Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Acronym: RSVTx
Sponsor: Enanta Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated due to a strategic business decision and not due to safety concerns.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-07
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Clinical trial NCT04235322: Study of 2LHERP® in Genital Herpes Infections
Official title: Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital Herpes Infections
Acronym: HEARTH-GEN
Sponsor: Labo'Life (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Labo'life decided to end prematurely HEARTH-GEN study from April 18th 2023 due to very low recruitment rates (6/100). Labo'life decided to focus all its efforts on another study using 2LHERP® in herpes treatment, called HEARTH-OF (NCT04065971)
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-25
Primary completion date: 2023-04-18
Completion date: 2023-04-18
Plan to share individual participant data: NO
Clinical trial NCT05005000: Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Official title: Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Difficulties getting subjects recruited and enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-12
Primary completion date: 2023-05-25
Completion date: 2023-05-25
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) upon reasonable request.
IPD time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD access criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Jacques.Hacquebord@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Clinical trial NCT02554903: Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Official title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Acronym: SOPRANO
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-28
Primary completion date: 2020-03-13
Completion date: 2020-03-13
Limitations and caveats: A limitation of this study was its slow enrollment and a final sample size that was less than the predefined target.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03558984: D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Official title: Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections
Sponsor: PolyPid Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: company prioritization reasons
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-17
Primary completion date: 2022-10-24
Completion date: 2022-10-24
Plan to share individual participant data: NO
Clinical trial NCT04315246: 177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)
Official title: A Phase I/II Trial of Intracerebroventricular 177Lu DTPA Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors
Sponsor: Y-mAbs Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Business priorities
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03553615: Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
Official title: Open-label Pilot Clinical Trial of Oral Ivermectin to Treat Atopic Dermatitis
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Limited clinical capacity
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-31
Primary completion date: 2019-12-31
Completion date: 2020-12-31
Clinical trial NCT03982134: PDR001 + Panobinostat for Melanoma and NSCLC
Official title: Phase Ib Study to Assess Safety and Tolerability of PDR001 in Combination With Panobinostat in Metastatic Melanoma and Non-small Cell Lung Cancer After Failure of Prior Anti PD1 or PD-L1 Therapy
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor decision to withdraw
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-30
Primary completion date: 2021-05-01
Completion date: 2022-05-01
Plan to share individual participant data: NO
Clinical trial NCT04629651: Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms
Official title: Phase I/II Prospective Trial Investigating the Safety and Efficacy of Captopril Use on the Degree of Marrow Fibrosis in Patients With Primary or Secondary Bone Marrow Fibrosis/Myeloproliferative Neoplasms
Sponsor: Case Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: PI discretion
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-04-30
Primary completion date: 2024-10-31
Completion date: 2024-10-31
Plan to share individual participant data: YES
IPD sharing description: There is a plan to make all individual participant data (IPD) and related data dictionaries available. We will also make the protocol available.
Clinical trial NCT03990363: A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia
Official title: A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia
Acronym: SAPPHIRE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 861.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-07-23
Primary completion date: 2021-11-22
Completion date: 2021-11-22
Limitations and caveats: The study was initially planned to be 108 weeks. However, following the implementation of the amendment in Protocol Version 5.0, all patients discontinued therapy after 60 weeks (Visit 10).~Subjects that were on Low dose at Visit 9 were switched to 24 mg dose.~The study was terminated in Mexico in March 2021.
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 de-identified 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 NCT02831179: Veliparib, Capecitabine, and Temozolomide in Patients With Advanced, Metastatic, and Recurrent Neuroendocrine Tumor
Official title: A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Loss of funding support
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-31
Primary completion date: 2019-02-28
Completion date: 2020-02-29
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04727528: Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
Official title: A Double-blind Randomized Placebo-controlled Parallel Design Multicenter Phase IIIb Study of the Effect of Sodium Zirconium Cyclosilicate (SZC) on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease (NEUTRALIZE)
Acronym: NEUTRALIZE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was stopped due to a higher than expected screen fail rate (83%) which lead to very low patient enrollment into the study. It should be noted that the decision to terminate the study is not related to safety concerns.
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-22
Primary completion date: 2022-09-14
Completion date: 2022-09-14
Baseline population: Full analysis set
Limitations and caveats: Due to a screening failure rate higher than expected which led to early termination of the study, only 39 (17.0%) patients entered the open-label phase. Due to the early termination of the study and small sample size, the study was underpowered for the secondary efficacy endpoints.
Clinical trial NCT03887533: Combined Intrathecal and Intravenous VTS-270 Therapy for Liver and Neurological Disease Associated With Niemann-Pick Disease, Type C1
Official title: Combined Intrathecal and Intravenous VTS-270 Therapy for Liver and Neurological Disease Associated With Niemann-Pick Disease, Type C1
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Enrollment was poor due to COVID-19 pandemic
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2021-10-25
Completion date: 2021-10-25
Limitations and caveats: Enrollment was poor due to COVID-19 pandemic
Clinical trial NCT04681677: Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab
Official title: Phase II Study of Patients With Recurrent Glioblastoma Multiforme Treated With Maximal Safe Neurosurgical Resection and Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab
Acronym: IORT
Sponsor: Xoft, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: unspecified business decision
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-02
Primary completion date: 2024-04-24
Completion date: 2024-04-24
Plan to share individual participant data: NO
IPD sharing description: No IPD will be shared
Clinical trial NCT04611139: Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers
Official title: Pilot Feasibility and Efficacy Trial of a Novel Reversible LSD1 Inhibitor SP-2577 (Seclidemstat) Plus Pembrolizumab in Select SWI/SNF-mutant Gynecologic Cancers
Sponsor: HonorHealth Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Salarius discontinued support
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-31
Primary completion date: 2023-12-31
Completion date: 2024-06-30
Plan to share individual participant data: NO
Clinical trial NCT03585712: Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill
Official title: A Prospective, Multi-center, Randomized, Cross-over Study to Assess the Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill
Sponsor: HRA Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-24
Primary completion date: 2020-04-07
Completion date: 2020-04-07
Baseline population: All subjects enrolled in the study
Plan to share individual participant data: NO
Clinical trial NCT03580356: A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Official title: A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1078.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-20
Primary completion date: 2021-06-22
Completion date: 2022-06-14
Baseline population: Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
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 NCT05481489: Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution
Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.
Acronym: PRO-230
Sponsor: Laboratorios Sophia S.A de C.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Due to sponsors convenience.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-02-01
Primary completion date: 2023-03-31
Completion date: 2023-04-24
Plan to share individual participant data: NO
Clinical trial NCT04583592: Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
Sponsor: Sagent Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 295.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-09
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Baseline population: The Intent-to-Treat population includes all subjects who were randomized. \[Note: Subjects may have more than one risk factor upon entry into study.\]
Plan to share individual participant data: NO
Clinical trial NCT05764239: Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
Official title: A Phase 3, Double-blind, Placebo-controlled, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
Acronym: SYNPHENY-3
Sponsor: Synlogic (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on a review of interim data from participants in the dose-escalation phase, it was determined that the study was unlikely to meet the primary endpoint.
Enrollment: 35.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-07-05
Primary completion date: 2024-03-15
Completion date: 2024-03-15
Baseline population: All participants who took at least 1 dose of SYNB1934v1 in the indicated study period (DEP or OLE) or who were randomized into the RWP.
Limitations and caveats: Early termination leading to small numbers of participants analyzed
Plan to share individual participant data: NO