chufangao/CTO huggingface dataset:
Clinical trial NCT04059094: A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1
Official title: A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Not due to safety reasons
Enrollment: 52.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-09-16
Primary completion date: 2020-04-16
Completion date: 2020-04-24
Baseline population: Treated set (TS): The TS included all patients who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received.
Limitations and caveats: This trial was prematurely discontinued with only adult patients being recruited.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT03113409: Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
Official title: Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: no funding available to continue
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-06-01
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Clinical trial NCT04243941: PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer
Official title: LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
Sponsor: UNC Lineberger Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding unavailable
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-29
Primary completion date: 2024-02-07
Completion date: 2024-02-07
Plan to share individual participant data: NO
Clinical trial NCT04307693: Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Official title: Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
Sponsor: Asan Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated early because no patients were further enrolled since mid-Apr 2020.
Enrollment: 65.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-03-11
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Plan to share individual participant data: NO
Clinical trial NCT02993094: Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer
Official title: Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Due to slow recruitment, the study had to be terminated prematurely.
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-11-21
Primary completion date: 2020-08-15
Completion date: 2020-08-15
Plan to share individual participant data: NO
Clinical trial NCT03757897: The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics.
Official title: The Influence of Dexmedetomidine Hypnosis on Cerebrospinal Fluid (CSF) Volume, Brain Diffusion and 'Stiffness' Characteristics
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The investigators were unable to implement a MRI compatible EEG for use in human subjects (equipment and technical issues).
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-31
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Clinical trial NCT04235049: Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)
Official title: Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations
Acronym: ECLIPSE
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Department of Corrections unable to support study at this time and find agreement on publication issue.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-01
Primary completion date: 2022-03-30
Completion date: 2024-10-30
Clinical trial NCT04797468: A Phase 1 Study of the CD73 Inhibitor(HLX23) Alone in Participants With Solid Tumor
Official title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of HLX23 (CD73 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors
Sponsor: Shanghai Henlius Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The Early Termination is the result of the sponsor's need to reevaluate the study design and to make needed vendor realignments.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-18
Primary completion date: 2023-01-13
Completion date: 2023-01-13
Clinical trial NCT05075304: A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients
Official title: A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
Enrollment: 18.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-21
Primary completion date: 2020-04-14
Completion date: 2020-04-14
Plan to share individual participant data: NO
Clinical trial NCT03724955: Pilot E2 for Hypogonadal Women With CFBD
Official title: Pilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and Osteopenia
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Issues with Recruitment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-30
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Clinical trial NCT03408873: CAE Plus LAI in Individuals With Bipolar Disorder at Risk for Treatment Non-adherence (BD-CAEL)
Official title: Enhancing Adherence and Outcomes in Bipolar Disorder With Abilify Maintena + a Targeted Behavioral Approach to Promote Sustained Adherence and Behavioral Change
Sponsor: University Hospitals Cleveland Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-01
Primary completion date: 2020-05-06
Completion date: 2020-05-06
Limitations and caveats: This study had a number of limitations including small sample, non-controlled design, and single-site setting. An additional limitation is that adherence was based upon self-report, which has potential to under-count missed medication. The improvement in adherence behaviors immediately after screen (and before CAE was administered) may possibly reflect a Hawthorne effect which could have obscured improvement in CAE-related change.
Clinical trial NCT04278755: Binge Eating & Birth Control
Official title: A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Halted prematurely due to COVID-19-related enrollment challenges.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-24
Primary completion date: 2022-05-17
Completion date: 2022-05-17
Limitations and caveats: The study was terminated early due to the inability to recruit eligible participants therefore only a very small number of participants have available data.
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
IPD time frame: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication upon reasonable request.
IPD access criteria: Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.
Clinical trial NCT05088421: A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers
Sponsor: Bugworks Research Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-05
Primary completion date: 2022-12-29
Completion date: 2023-05-28
Plan to share individual participant data: NO
Clinical trial NCT03480022: Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
Official title: A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)
Acronym: SAXAPCOS
Sponsor: Woman's (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-26
Primary completion date: 2021-02-22
Completion date: 2021-05-19
Plan to share individual participant data: NO
Clinical trial NCT02435433: A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib
Acronym: REACH-2
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 399.0 (ACTUAL)
Number of arms: 5.0
Start date: 2015-07-20
Primary completion date: 2018-03-15
Completion date: 2021-11-19
Baseline population: All participants who received at least one dose of study drug.
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 NCT05788991: Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
Official title: Comparative Study of the Efficacy and Safety of Vaginally Applied Dequalinium Chloride (10 mg) and Orally Applied Metronidazole (2 x 500 mg) in the Treatment of Bacterial Vaginosis
Sponsor: Medinova AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 151.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-26
Primary completion date: 2022-08-25
Completion date: 2022-08-25
Baseline population: Randomized= 151 patients but 4 did not receive study medication because of consent withdrawal (1 for dequalinium chloride, 3 for metronidazole) Received intervention= 147 (72 dequalinium chloride, 75 metronidazole) but 4 were missing the primary outcome assessment (3 for dequalinium chloride and 1 for metronidazole) Patients with data for primary endpoint analysis= 147 (69 dequalinium chloride, 74 metronidazole)
Clinical trial NCT05061992: A Trial to Improve Quality of Life in People With Cirrhosis
Official title: A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-10
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Plan to share individual participant data: NO
Clinical trial NCT05270863: Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
Official title: Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Sponsor: Visus Therapeutics (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 182.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-30
Primary completion date: 2023-03-17
Completion date: 2023-04-10
Plan to share individual participant data: NO
Clinical trial NCT02513667: Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma
Official title: Phase II Trial of Ceritinib in Combination With Stereotactic Ablative Radiation in ALK-rearranged Metastatic Lung Adenocarcinoma
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated after UTSW was informed by Novartis that further support for the study would not be provided
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-30
Primary completion date: 2020-05-29
Completion date: 2021-05-29
Baseline population: 1 patient withdrew consent before thier first scan.
Clinical trial NCT03425799: Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
Official title: Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
Sponsor: Exela Pharma Sciences, LLC. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low recruitment rate
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-17
Primary completion date: 2019-10-23
Completion date: 2020-01-21
Baseline population: Not Available. Study Terminated and data were not collected.
Plan to share individual participant data: NO
Clinical trial NCT05366751: A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor
Official title: An Open-label Study of the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor
Sponsor: Sage Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Internal company decision
Enrollment: 97.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-13
Primary completion date: 2024-09-10
Completion date: 2024-09-10
Plan to share individual participant data: NO
IPD sharing description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Clinical trial NCT04732468: COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
Official title: Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated early due to low enrollment.
Enrollment: 28.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-02-24
Primary completion date: 2022-07-11
Completion date: 2023-01-09
Limitations and caveats: The study was terminated early due to low enrollment.
Plan to share individual participant data: NO
Clinical trial NCT03234309: Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors
Official title: High Resolution Steady State Blood Volume Maps in Pediatric Brain Tumors Using MRI
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No enrollments
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-20
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Clinical trial NCT03802396: Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction
Official title: Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction (MARBLE): A Phase 2 Trial to Evaluate the Efficacy and Feasibility of CN-105 in Preventing Postoperative Cognitive Dysfunction and Delirium
Acronym: MARBLE
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 203.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-15
Primary completion date: 2022-12-28
Completion date: 2022-12-28
Baseline population: Participants who completed the study.
Plan to share individual participant data: NO
Clinical trial NCT02270632: A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.
Sponsor: Philogen S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.
Enrollment: 27.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-10-01
Primary completion date: 2019-04-30
Completion date: 2023-06-08
Clinical trial NCT01721772: Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma
Official title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Acronym: CheckMate 066
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 418.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-01-18
Primary completion date: 2014-06-24
Completion date: 2021-05-14
Baseline population: All participants randomized to receive treatment
Limitations and caveats: An independent data monitoring committee (DMC) found that data from a DMC-requested database lock showed clear survival benefit with nivolumab and thus recommended unblinding the study and switching patients randomized to dacarbazine to nivolumab.
Clinical trial NCT04235270: A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
Official title: Single-center, Open-label, Single-dose, 2-period, Randomized, Crossover Phase 1 Study to Demonstrate Bioequivalence of Tadalafil Administered as a Fixed Dose Combination Formulation of Macitentan/Tadalafil (10 mg/40 mg) and as the Free Combination of 10 mg Macitentan (Opsumit) and 40 mg Tadalafil (Adcirca), and to Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Formulation of Macitentan/Tadalafil (10 mg/40 mg) in Healthy Adult Participants
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-17
Primary completion date: 2020-07-17
Completion date: 2020-07-17
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 NCT05738161: Magrolimab in Combination With Cytotoxic Chemotherapy in Advanced Urothelial Carcinoma
Official title: A Phase 1, Single Arm Investigator-initiated Study to Investigate the Safety of Combining the Antibody Magrolimab With Standard First Line Platinum-based Chemotherapy (With Cisplatin / Gemcitabine) in Advanced Urothelial Carcinoma
Acronym: MACOCUC-01
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: IMP security Issues reported by Sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-06-21
Primary completion date: 2024-02-27
Completion date: 2024-02-27
Plan to share individual participant data: NO
Clinical trial NCT05652504: Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)
Official title: Phase 1 Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: The FDA has placed a clinical hold on the IND under which this research is to be conducted.
Enrollment: 400.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2024-10-21
Primary completion date: 2024-11-30
Completion date: 2024-11-30
Plan to share individual participant data: NO
Clinical trial NCT02568215: Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
Official title: A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1924.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-31
Primary completion date: 2021-03-03
Completion date: 2021-03-03
Baseline population: Safety Population