chufangao/CTO huggingface dataset:
Clinical trial NCT03318939: Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Official title: A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)
Sponsor: Spectrum Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic business decision (unrelated to safety)
Enrollment: 648.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-13
Primary completion date: 2023-04-03
Completion date: 2023-04-03
Plan to share individual participant data: NO
Clinical trial NCT06297642: TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors.
Official title: A Phase Ib Clinical Trial of TQB2928 Injection Combined With Penpulimab in the Treatment of Patients With Advanced Malignant Tumors.
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on the current status of the same target research and the company's overall layout in the field of tumors, the early termination was determined after full communication with the principal investigator of the group leader unit.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-05-24
Primary completion date: 2024-07-31
Completion date: 2024-07-31
Clinical trial NCT05115019: A Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection (COVID-19)
Official title: A Phase II/III, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection
Sponsor: PT. Innovative Pharma Solutions (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Decrease of incidence and severity of COVID and availability of therapeutic alternatives
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-31
Primary completion date: 2022-02-28
Completion date: 2022-04-30
Clinical trial NCT04766476: A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 9.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-02-24
Primary completion date: 2021-08-12
Completion date: 2021-08-12
Clinical trial NCT03066466: Randomized Study: Standard of Care With or Without Atorvastatin for Prevention of GVHD for Matched Unrelated Donor BMT
Official title: Randomized Study of Atorvastatin Prophylaxis as a Supplement to Standard of Care Prophylaxis to Prevent Chronic Graft Versus Host Disease Allogeneic Stem Cell Transplantation From Matched Unrelated Donors
Sponsor: Loyola University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No participants were enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-10
Primary completion date: 2020-02-28
Completion date: 2021-02-28
Plan to share individual participant data: NO
Clinical trial NCT03387111: QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed
Official title: QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-09
Primary completion date: 2019-04-17
Completion date: 2021-01-11
Clinical trial NCT03751436: Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer
Official title: Phase Ib/II Study of Enzalutamide With Venetoclax (ABT-199) in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Sponsor: Roswell Park Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-02
Primary completion date: 2022-07-18
Completion date: 2023-08-11
Clinical trial NCT04415658: Intravenous Thyroxine for Heart-Eligible Organ Donors
Official title: A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 838.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-01
Primary completion date: 2022-11-06
Completion date: 2022-12-06
Limitations and caveats: Not blinded, open-label use of levothyroxine permitted in control group after 12 hours (only 50 donors in that group received open-label, plus three who crossed-over to levothyroxine immediately after randomization)
Plan to share individual participant data: NO
IPD sharing description: Researchers within the study consortium only
Clinical trial NCT05384379: Efficacy and Safety Evaluation of BZ371B in ARDS Patients
Official title: Clinical Study to Evaluate the Efficacy and Safety od BZ371B in Patients With Acute Respiratory Distress System (ARDS) in Mechanical Ventilation, Due to Respiratory Infections
Sponsor: Biozeus Biopharmaceutical S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Suboptimal enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-23
Primary completion date: 2023-03-03
Completion date: 2023-03-03
Plan to share individual participant data: NO
Clinical trial NCT04144140: Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
Official title: An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas - INSTAL-101
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated earlier due to a business decision; which was unrelated to safety. In addition, there was no clinical activity data that informed the decision.
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-24
Primary completion date: 2022-07-26
Completion date: 2022-07-26
Baseline population: The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Limitations and caveats: The study was terminated earlier due to corporate strategic decision, which is unrelated to safety. In addition, there is no clinical activity data that informed the decision. Therefore, no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Plan to share individual participant data: YES
IPD sharing description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Clinical trial NCT02860117: Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients
Official title: The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study
Acronym: ccimb
Sponsor: University of Sao Paulo General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: change in hospital policy
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-31
Primary completion date: 2019-01-01
Completion date: 2020-05-01
Plan to share individual participant data: NO
Clinical trial NCT04599933: An Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (NEAR-1)
Official title: A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-1 Study: Near Eye-vision Acuity Restoration)
Acronym: NEAR-1
Sponsor: Orasis Pharmaceuticals Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 309.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-18
Primary completion date: 2022-02-11
Completion date: 2022-02-19
Baseline population: The subject demographics and characteristics presented are for the Full Analysis Set (FAS).
Clinical trial NCT04250350: Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Official title: An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Acronym: ADore
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 206.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-11
Primary completion date: 2022-04-20
Completion date: 2022-06-22
Baseline population: All enrolled or randomized 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 European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04752020: Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty
Official title: Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty
Sponsor: Massachusetts Eye and Ear Infirmary (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-28
Primary completion date: 2023-06-28
Completion date: 2023-12-30
Plan to share individual participant data: NO
Clinical trial NCT03531281: Human Lysozyme Goat Milk in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
Official title: A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Administratively withdrawn
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-30
Primary completion date: 2022-12-30
Completion date: 2022-12-30
Clinical trial NCT04186871: Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 119.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-01-07
Primary completion date: 2022-12-05
Completion date: 2022-12-05
Clinical trial NCT02087865: Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Official title: Effects of Donepezil HCL on Task-Activated fMRI Brain Activation in Healthy Older Adults at Genetic Risk for Alzheimer's Disease
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 89.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-05-31
Primary completion date: 2021-12-20
Completion date: 2021-12-20
Baseline population: The number reflects the participants who completed the study in the respective study groups.
Clinical trial NCT03627767: Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
Official title: A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1235.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-11
Primary completion date: 2020-09-02
Completion date: 2020-10-07
Baseline population: Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within Double-blind (DB) phase.
Limitations and caveats: For outcome measure, Time to loss of response, the data collection window was extended for 45 days beyond the scheduled visit due to COVID 19.
Plan to share individual participant data: YES
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 NCT05151471: Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
Official title: A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Mitsubishi Tanabe Pharma America Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Futility Analysis of parent study MT-1186-A02 was met.
Enrollment: 202.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-11
Primary completion date: 2023-09-29
Completion date: 2023-09-29
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03733067: Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency
Official title: Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-lymphocyte Antigen 4 (CTLA4) Haploinsufficiency
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-11-30
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: NO
Clinical trial NCT04035850: Vortioxetine for the Treatment of Hoarding Disorder
Official title: Vortioxetine for the Treatment of Hoarding Disorder- an Open Label Study
Sponsor: St. Joseph's Healthcare Hamilton (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: COVID-19 pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-01
Primary completion date: 2021-08-01
Completion date: 2021-08-01
Plan to share individual participant data: NO
Clinical trial NCT05448391: A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF)
Official title: An Open-label, Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of RIST4721 in Subjects With Familial Mediterranean Fever
Sponsor: Aristea Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to safety findings in other ongoing Phase 2 trials.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-13
Primary completion date: 2023-11-30
Completion date: 2024-12-30
Plan to share individual participant data: NO
Clinical trial NCT04379336: BCG Vaccination for Healthcare Workers in COVID-19 Pandemic
Official title: Reducing Morbidity and Mortality in Health Care Workers Exposed to SARS-CoV-2 by Enhancing Non-specific Immune Responses Through Bacillus Calmette-Guérin Vaccination, a Randomized Controlled Trial
Sponsor: TASK Applied Science (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1000.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-04
Primary completion date: 2022-01-02
Completion date: 2022-01-02
Plan to share individual participant data: NO
IPD sharing description: IPD will only be shared among researchers included in the protocol team at this stage.
Clinical trial NCT04841512: Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis
Official title: A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain
Sponsor: Xalud Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: COVID - Lack of recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-31
Primary completion date: 2022-03-01
Completion date: 2022-03-01
Plan to share individual participant data: NO
IPD sharing description: Not applicable. All patient records are de-identified
Clinical trial NCT04785924: Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections
Official title: A Study Comparing Prospective Use of Imipenem/Cilastatin/Relebactam (IMI/REL) to Retrospective Data Using Meropenem/ Vabobactam (MVB) and Ceftazidime/Avibactam (CZA) in Treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae Infections
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-07
Primary completion date: 2023-01-12
Completion date: 2023-01-12
Plan to share individual participant data: NO
Clinical trial NCT02876835: Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Official title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3872.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-27
Primary completion date: 2021-04-19
Completion date: 2021-04-19
Baseline population: All Randomized (Intent-to-treat \[ITT\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Clinical trial NCT01576172: Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Official title: A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone With or Without ABT-888 for Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-03-30
Primary completion date: 2019-10-23
Completion date: 2020-04-23
Clinical trial NCT02624388: Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
Official title: A Randomized, Placebo-Controlled Pilot Study of Genistein Supplementation in Pediatric Cancer Patients Receiving Myelosuppressive Chemotherapy
Acronym: UVA-Gen001
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor enrollment
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-08-31
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT04793620: Pertussis Acellular Vaccine Adjuvanted With TQL1055
Official title: A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)
Sponsor: Adjuvance Technologies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: financial constraints
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-06
Primary completion date: 2021-08-23
Completion date: 2022-02-14
Plan to share individual participant data: NO
Clinical trial NCT04498169: A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Official title: A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Acronym: Fuchs
Sponsor: Aerie Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-17
Primary completion date: 2021-08-11
Completion date: 2021-08-11
Baseline population: 40 participants were randomized; 20 each to the Netarsudil QD and the Netarsudil BID arms. 1 participant discontinued from each arm due to adverse events.~40 participants were included in both the mITT population for the primary endpoint analysis and the safety population for safety analysis.~6 participants were excluded from the per-protocol analysis due to protocol deviations (2 in the Netarsudil QD arm, 4 in the Netarsudil BID arm). There were no Covid-19 related protocol deviations.
Plan to share individual participant data: NO