chufangao/CTO huggingface dataset:
Clinical trial NCT05718297: Brigatinib Post Definitive Chemo-radiotherapy in Patients with ALK-fusion Non-small Cell Lung Cancer
Official title: A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients with Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy
Acronym: BOUNCE
Sponsor: ETOP IBCSG Partners Foundation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Despite our efforts, the trial faced challenges like a longer activation period and slower accrual. We proposed a redesign, but TAKEDA withdrew. As a non-profit organisation, we can't continue without TAKEDA's support and must discontinue the trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-06-07
Primary completion date: 2024-09-30
Completion date: 2024-09-30
Plan to share individual participant data: YES
Clinical trial NCT03639714: A Study of a Personalized Neoantigen Cancer Vaccine
Official title: An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors
Sponsor: Gritstone bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-13
Primary completion date: 2022-11-10
Completion date: 2022-11-10
Clinical trial NCT03551626: Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
Official title: COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)
Acronym: COMBI-APlus
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 552.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-29
Primary completion date: 2020-10-05
Completion date: 2021-09-16
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 NCT03359174: An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis
Official title: An Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing Cholangitis
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-29
Primary completion date: 2020-12-01
Completion date: 2021-01-01
Clinical trial NCT05935332: Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy
Sponsor: RAPT Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study on clinical hold by FDA
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-07-05
Primary completion date: 2024-06-21
Completion date: 2024-06-21
Plan to share individual participant data: NO
Clinical trial NCT02430558: Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft
Official title: Second Line Treatment of Knee Osteochondral Lesion With Decellularized Treated Osteochondral Allograft. Phase IIa Trial
Acronym: ODPHOENIX2
Sponsor: TBF Genie Tissulaire (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low accrual rate
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-05
Primary completion date: 2021-06-15
Completion date: 2021-06-15
Clinical trial NCT04996667: Effect of iNO in Patients With Submassive and Massive PE
Official title: Study to Evaluate the Role of Inhaled Nitric Oxide (iNO) on Pulmonary Hemodynamics in Patients With Intermediate/Submassive and Massive Pulmonary Embolism (PE)
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: no sponsor support
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2022-12-31
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT02977195: First in Human Evaluation of Safety, Pharmacokinetics, and Clinical Activity of a Monoclonal Antibody Targeting Netrin 1 in Patients With Advanced/Metastatic Solid Tumors
Official title: NP137 - An Open-label, First in Human, Phase I Trial Aiming to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of a Humanized Monoclonal Antibody Targeting Netrin 1 (NP137) in Patients With Advanced/Metastatic Solid Tumors.
Acronym: NP137
Sponsor: Centre Leon Berard (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-09
Primary completion date: 2021-12-31
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT02500121: Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer
Official title: A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-11
Primary completion date: 2019-07-01
Completion date: 2021-01-01
Baseline population: One patient randomly assigned to placebo was excluded from the analysis because of inconsistent receipt of pembrolizumab rather than placebo during the initial several cycles of study treatment.
Plan to share individual participant data: NO
Clinical trial NCT02127658: MRSA Eradication and Decolonization in Children
Official title: MRSA Eradication and Decolonization in Children
Acronym: MEDiC
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to recruit all planned participants prior to end of funding
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-18
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Limitations and caveats: We enrolled 14 subjects with only 9 completing at least one outcome assessment. This was far below the 118 (total) or 59/arm needed for appropriate statistical analysis.
Plan to share individual participant data: NO
Clinical trial NCT04078386: A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
Official title: A Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's Syndrome
Sponsor: RemeGen Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-21
Primary completion date: 2021-06-23
Completion date: 2021-10-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05305040: Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Official title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Acronym: Prevent
Sponsor: AlloVir (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Study discontinued as DSMB determined it was futile. No safety concerns were noted.
Enrollment: 451.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-24
Primary completion date: 2024-01-30
Completion date: 2024-01-30
Baseline population: Safety Population: included all participants who received at least one dose of posoleucel or placebo.
Limitations and caveats: The Sponsor decided to discontinue the Phase 3 part of the trial on 22 Dec 2023 following a pre-planned DSMB futility analysis concluding the study was unlikely to meet its primary endpoint; no safety concerns were identified. Data was not collected for efficacy analyses at Week 26 as planned. Participants were monitored through Week 26 for safety analyses.
Plan to share individual participant data: NO
Clinical trial NCT03817528: ITI-007 (Lumateperone Tosylate) for Schizophrenia
Official title: ITI-007 (Lumateperone Tosylate) for Schizophrenia
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: ITI-007 approved by FDA
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-01
Primary completion date: 2020-09-23
Completion date: 2020-09-23
Baseline population: Baseline population is participants who received at least one dose of study drug
Clinical trial NCT03829332: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)
Official title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 623.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-13
Primary completion date: 2021-05-19
Completion date: 2024-04-24
Baseline population: All participants randomized by intention to treat (ITT).
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT00529035: Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
Official title: A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2007-08-31
Primary completion date: 2011-06-30
Completion date: 2020-05-27
Clinical trial NCT04914676: Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission
Official title: Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) in Complete Remission
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI decision to close study early due to limited data due to accrual goal not being met
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-08
Primary completion date: 2024-01-12
Completion date: 2024-08-26
Clinical trial NCT04797767: Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Official title: A Phase 1 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Phase transition/study design changes - additional phase/cohort/arms pending. Start-up activity temporarily suspended
Enrollment: 20.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2022-02-04
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT02202304: The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient
Official title: The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.
Sponsor: University of Aberdeen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Researcher changed jobs. Unable to carry out the project
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-10
Primary completion date: 2019-09-10
Completion date: 2020-12-10
Plan to share individual participant data: YES
IPD sharing description: within 6 months
Clinical trial NCT04066751: The Multicenter Topic Trial
Official title: A Multicenter Randomized, Double-blind, Phase 2, Placebo Controlled Study to Determine the Safety and Efficacy of Ivacaftor (VX-770) for the Treatment of Chronic Obstructive Pulmonary Disease (The Multicenter Topic Trial)
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study never started due to change in availability of study drug
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2024-10-31
Completion date: 2024-10-31
Plan to share individual participant data: NO
Clinical trial NCT03912350: The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan
Official title: The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan: A Phase I, Multiple-Center, Open-Label Study Following Multiple Daily Oral Doses of Balovaptan in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The study is on hold due to stopping of the Autism Spectrum Disorder program with balovatpan, the study drug.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-26
Primary completion date: 2022-09-24
Completion date: 2022-10-13
Plan to share individual participant data: NO
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT05074498: Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
Official title: A Seamless Phase 1b/2a Double-blind, Randomized, Multiple Dose, Multi-center, Sequential Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of TB006 in Patients With Mild to Severe Alzheimer's Disease
Sponsor: TrueBinding, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 154.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-08
Primary completion date: 2022-10-13
Completion date: 2022-10-13
Baseline population: Safety Analysis Set comprised of all participants randomly assigned to study drug and who took at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT03503773: The TARGET BP OFF-MED Trial
Official title: A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications
Sponsor: Ablative Solutions, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 350.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-24
Primary completion date: 2022-01-31
Completion date: 2024-01-10
Clinical trial NCT03980730: Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Acronym: Elevage
Sponsor: vTv Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: for business reasons
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-27
Primary completion date: 2020-12-01
Completion date: 2021-01-29
Plan to share individual participant data: NO
Clinical trial NCT03437668: Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Official title: Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Unable to reach enrollment target due to COVID
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-01
Primary completion date: 2023-06-12
Completion date: 2023-06-12
Plan to share individual participant data: UNDECIDED
IPD sharing description: Deidentified will be submitted an NIH repository
Clinical trial NCT04536077: Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients
Official title: Testing the Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Celldex decision
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-13
Primary completion date: 2023-11-21
Completion date: 2023-11-21
Plan to share individual participant data: NO
Clinical trial NCT04408183: GLS-1200 Topical Nasal Spray to Prevent SARS-CoV-2 Infection (COVID-19)
Official title: Efficacy, Safety, and Tolerability of GLS-1200 Topical Nasal Spray in the Prevention of Incident Confirmed, Symptomatic SARS-CoV-2 Infection
Sponsor: GeneOne Life Science, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No longer enrolling
Enrollment: 184.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-10
Primary completion date: 2023-01-10
Completion date: 2023-01-10
Clinical trial NCT05167253: A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines.
Official title: A Phase I, Open-label Study to Evaluate the Ability of UB-612 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines
Sponsor: United Biomedical Inc., Asia (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Regulatory issues raised by the regulatory authority in Taiwan.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-15
Primary completion date: 2022-04-15
Completion date: 2022-10-31
Clinical trial NCT04444752: A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Sponsor: Suzhou Connect Biopharmaceuticals, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 226.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-07-17
Primary completion date: 2021-07-28
Completion date: 2021-09-22
Plan to share individual participant data: NO
Clinical trial NCT03724968: Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression
Official title: A Phase II Two-Arm Open-Label Study of Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Loss of funding
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-17
Primary completion date: 2020-05-28
Completion date: 2020-05-28
Baseline population: Study stopped early due to low accrual and no participants were enrolled to Arm A
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02711826: Treg Therapy in Subclinical Inflammation in Kidney Transplantation
Official title: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21)
Acronym: TASK
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-20
Primary completion date: 2023-08-04
Completion date: 2023-08-04
Baseline population: Intent-to-treat population who initiated study treatment, reflecting reassignment of participants from either the polyTregs or darTregs group to the Maintenance group.
Plan to share individual participant data: YES
IPD sharing description: The plan is to share data in ImmPort \[https://immport.niaid.nih.gov/ \], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the study.
Clinical trial NCT04311489: Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.
Official title: Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Safety, Tolerability and Efficacy of Ularitide in Cirrhosis Patients With Refractory Ascites.
Acronym: ULA04
Sponsor: University of Aarhus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Interim analysis showing safety concerns
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-01
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Clinical trial NCT04102618: A Window-of-opportunity Study of Pelareorep in Early Breast Cancer
Official title: A Window-of-opportunity Study of Pelareorep in Early Breast Cancer (AWARE-1)
Acronym: AWARE-1
Sponsor: Oncolytics Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Enrollment into AWARE cohorts1-4 have concluded and the primary objective and core goals for the study were met.
Enrollment: 26.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-03-29
Primary completion date: 2022-04-20
Completion date: 2022-04-20
Clinical trial NCT04469465: Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)
Official title: A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-16
Primary completion date: 2022-06-29
Completion date: 2024-01-16
Baseline population: The safety set included all participants that received at least 1 dose of study drug (danicopan or placebo).