chufangao/CTO huggingface dataset:
Clinical trial NCT03347110: A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Official title: A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
Acronym: BE ACTIVE 2
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 184.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-22
Primary completion date: 2020-10-29
Completion date: 2020-10-29
Baseline population: Baseline Characteristics refer to SS which consisted of all study participants who had given informed consent for PA0009 and had received at least one dose of study medication in PA0009.
Plan to share individual participant data: NO
Clinical trial NCT03047395: A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
Official title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)
Acronym: LIMMITLESS
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2172.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-27
Primary completion date: 2023-11-29
Completion date: 2023-11-29
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, analyses plans, 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: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT04982289: Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia Gravis
Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia Gravis
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decision to terminate program
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-01
Primary completion date: 2023-01-31
Completion date: 2024-01-31
Clinical trial NCT04838795: Sisonke (Together): OPEN LABEL TRIAL COVID-19
Official title: Open-label, Single-arm Phase 3B Implementation Study to Monitor the Effectiveness of the Single-dose Ad26.COV2.S COVID-19 Vaccine Among Health Care Workers in South Africa (VAC31518COV3012)
Acronym: Sisonke
Sponsor: Wits Health Consortium (Pty) Ltd (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 477102.0 (ACTUAL)
Start date: 2021-02-17
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05024825: Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Official title: Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Sponsor: Albany Medical College (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruitment target not met.
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-04
Primary completion date: 2021-05-19
Completion date: 2021-05-19
Clinical trial NCT04443868: Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection
Official title: Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19
Sponsor: Sanotize Research and Development corp. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No subjects enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-31
Primary completion date: 2021-04-30
Completion date: 2021-07-31
Plan to share individual participant data: NO
Clinical trial NCT05302804: The Influence of Menthol Gel During Exercise With Heat
Official title: The Influence of Topical Menthol Gel on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat
Sponsor: University of Nebraska (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-01
Primary completion date: 2022-10-01
Completion date: 2022-10-01
Plan to share individual participant data: NO
Clinical trial NCT03831191: A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study
Acronym: ADmIRe
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated for lack of efficacy after an interim analysis was performed
Enrollment: 136.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-02-12
Primary completion date: 2020-02-27
Completion date: 2020-02-27
Baseline population: All randomized participants.
Limitations and caveats: The study was terminated for lack of efficacy after an interim analysis was performed.
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 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 NCT03238651: A Study of TAK-659 as a Single Agent in Adult East Asian Participants With Non-Hodgkin Lymphoma (NHL)
Official title: A Phase 1, Open-label Study of TAK-659 as a Single Agent in Adult East Asian Patients With Non-Hodgkin Lymphoma
Sponsor: Calithera Biosciences, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Termination of the study by the sponsor due to business decision.
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-01
Primary completion date: 2020-08-17
Completion date: 2020-08-17
Baseline population: The safety analysis set included participants who received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04785144: Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
Official title: Phase 1, Open-Label, Randomized Study of the Safety and Immunogenicity of a SARS-CoV-2 Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 135.0 (ACTUAL)
Number of arms: 10.0
Start date: 2021-03-31
Primary completion date: 2022-07-05
Completion date: 2022-07-05
Clinical trial NCT01416636: Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
Official title: A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH)
Acronym: CTREPH
Sponsor: SciPharm SàRL (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 105.0 (ACTUAL)
Number of arms: 2.0
Start date: 2009-03-31
Primary completion date: 2016-11-30
Completion date: 2021-04-30
Clinical trial NCT04365582: OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome
Official title: A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization
Acronym: OUTCOV
Sponsor: Fondation Hôpital Saint-Joseph (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The PI decided.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-05-07
Primary completion date: 2020-12-31
Completion date: 2021-04-19
Plan to share individual participant data: NO
Clinical trial NCT05327816: A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of Various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Based on recent study data from VAC18193, it was decided to terminate the study. There are no underlying safety concerns to terminate VAC18195RSV1001
Enrollment: 132.0 (ACTUAL)
Number of arms: 19.0
Start date: 2022-04-13
Primary completion date: 2023-01-16
Completion date: 2023-02-14
Baseline population: The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
Limitations and caveats: Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT05400577: Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC
Official title: Neoadjuvant Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Fox Chase Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Grantor withdrew support due to slow accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-13
Primary completion date: 2024-01-01
Completion date: 2024-02-01
Plan to share individual participant data: NO
Clinical trial NCT03255083: DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
Official title: A Multicenter, Open-Label Phase 1 Study of DS-1205c in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant Non-Small Cell Lung Cancer
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was terminated based on a business decision by the Sponsor.
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-10
Primary completion date: 2020-09-04
Completion date: 2020-09-04
Baseline population: Demographic and baseline characteristics were assessed in the Full Analysis Set.
Limitations and caveats: This study was terminated based on a business decision by the Sponsor.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT05386550: Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)
Official title: A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: No major safety concerns were identified in XRAY VISION study, but Lack of evidence of efficacy of meaningful clinical benefit.
Enrollment: 166.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-06
Primary completion date: 2024-08-27
Completion date: 2024-08-27
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT03872336: Acute Labetalol Use in Preeclampsia
Official title: Acute Labetalol Use in Preeclampsia Randomized Trial
Acronym: ALERT
Sponsor: Albany Medical College (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow enrollment
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-18
Primary completion date: 2020-07-20
Completion date: 2020-07-20
Plan to share individual participant data: NO
Clinical trial NCT03699904: Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO).
Acronym: EViSCO
Sponsor: Belfast Health and Social Care Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: In light of the evolving Covid19 pandemic ongoing study recruitment was felt to pose an unacceptable risk to patient safety.
Enrollment: 85.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-11
Primary completion date: 2020-05-07
Completion date: 2020-07-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04480138: Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
Official title: A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)
Sponsor: Zydus Lifesciences Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to non availability of eligible subjects and slow recruitment
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-11
Primary completion date: 2021-06-21
Completion date: 2021-06-21
Plan to share individual participant data: NO
Clinical trial NCT03073200: Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Official title: Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
Acronym: Ixora-peds
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 201.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-03-28
Primary completion date: 2019-02-07
Completion date: 2021-03-23
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 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 NCT04684121: Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing
Official title: A Phase 2, Prospective, Randomized, Double-Blind, Parallel-Group, Within-Subject Vehicle Controlled Multicenter Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing
Sponsor: Xequel Bio, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No longer aligned with company strategy
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-01
Primary completion date: 2024-08-01
Completion date: 2024-08-01
Plan to share individual participant data: NO
Clinical trial NCT05538312: A Study to Understand the Effect of Itraconazole on the Levels of a Study Medicine Called ARV-471 in Healthy Adults
Official title: AN INTERVENTIONAL, PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF SINGLE DOSE ARV-471 IN THE FED CONDITION IN HEALTHY ADULT MALES, AND FEMALES OF NONCHILDBEARING POTENTIAL
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-02-23
Primary completion date: 2023-04-24
Completion date: 2023-05-22
Baseline population: Baseline participants included all participants enrolled and who took at least 1 dose of study intervention.
Limitations and caveats: AUCinf for ARV-473 could only be reported for 2 of 12 participants in Period 1 (ARV-471 alone) and 6 of 12 participants in Period 2 (ARV-471 + itraconazole) based on protocol prespecified criteria, therefore was not used as the primary endpoint for ARV-473. Furthermore, AUC120, was selected as the primary endpoint for ARV-473 in lieu of AUClast to account for the difference in sampling intervals between Test Treatment (0-168 hours) and Reference Treatment (0-120 hours).
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT03100006: Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
Official title: A Phase Ib/IIa Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Nivolumab as a Combinatorial Immunotherapy Strategy in Patients With Recurrent Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
Acronym: ORION-01
Sponsor: National Cancer Centre, Singapore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study had poor efficacy.
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-22
Primary completion date: 2019-06-07
Completion date: 2020-04-17
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05917470: A Clinical Study of ONCT-534 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Official title: A Phase 1/2 Study of ONCT-534 in Subjects with Metastatic Castration-Resistant Prostate Cancer
Sponsor: Oncternal Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Interim Phase 1 results of ONCT-534 did not show clinically meaningful improvements of disease, including prostate-specific antigen (PSA) levels, in the 20 patients treated in eight dosing cohorts with various doses and schedules of administration.
Enrollment: 21.0 (ACTUAL)
Number of arms: 8.0
Start date: 2023-09-20
Primary completion date: 2024-09-12
Completion date: 2024-09-12
Plan to share individual participant data: UNDECIDED