chufangao/CTO huggingface dataset:
Clinical trial NCT04768478: CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF
Official title: The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Ankle and Tibia Fracture Open Reduction and Internal Fixation. A Double-Blind, Randomized Control Study
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: there was no funding to begin the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-01
Primary completion date: 2023-10-01
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD access criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Philipp.Leucht@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Clinical trial NCT04156100: A Study in Subjects With Advanced Solid Tumors
Official title: A Phase 1 Study of AGEN1223, a Bispecific Fc-Engineered Antibody as a Single Agent and in Combination With Balstilimab, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Solid Tumors
Sponsor: Agenus Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic business decision.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-10
Primary completion date: 2021-04-08
Completion date: 2021-09-29
Plan to share individual participant data: NO
Clinical trial NCT05190419: Study to Assess the Efficacy and Safety of Orismilast in Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate-to-Severe Plaque-Type Psoriasis
Acronym: IASOS
Sponsor: UNION therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 202.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-12-30
Primary completion date: 2022-11-24
Completion date: 2022-12-20
Baseline population: The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT04985656: A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes
Official title: A Phase 2, Open-Label Study of Intravenous Pevonedistat in Combination With Oral Decitabine and Cedazuridine in Adult Patients With Higher-Risk Myelodysplastic Syndromes
Acronym: PEVOBINE
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor Decision to Terminate Trial
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-01
Primary completion date: 2024-01-08
Completion date: 2024-11-08
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 NCT03606213: Therapeutic Vaccination in Treated HIV Disease
Official title: Safety, Immunogenicty and Anti-Reservoir Activity of an Electroporation-Administered HIV DNA Vaccine Encoding GAG, POL and ENV Proteins With IL-12 Plasmid in HIV-Infected Adults on Antriretroviral Therapy.
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-01
Primary completion date: 2021-05-17
Completion date: 2021-05-17
Plan to share individual participant data: NO
Clinical trial NCT04999020: Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
Official title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-19
Primary completion date: 2023-10-26
Completion date: 2024-05-08
Plan to share individual participant data: YES
IPD sharing description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Clinical trial NCT04315961: Effects of Dietary Conditions on Drug Response
Official title: Effects of Dietary Conditions on Drug Response
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Unable to recruit participants.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-18
Primary completion date: 2023-02-02
Completion date: 2023-02-02
Baseline population: The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Limitations and caveats: Early termination - Study was terminated due to COVID 19 lockdown and subsequent research restrictions.
Plan to share individual participant data: NO
IPD sharing description: There is not currently a plan to make individual participant data available to other researchers.
Clinical trial NCT03954938: Behavioral Effects of Drugs (Inpatient): 38
Official title: Influence of Craving Manipulation on Cocaine Self-Administration
Sponsor: University of Kentucky (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: COVID-19
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-15
Primary completion date: 2021-12-03
Completion date: 2021-12-03
Baseline population: Completing subjects
Limitations and caveats: Early termination leading to small numbers of subjects analyzed; only completing subjects' data analyzed due to within subjects design.
Plan to share individual participant data: NO
Clinical trial NCT03238157: Steroids for Early Treatment of Radiation Retinopathy
Official title: Steroids for Early Treatment of Radiation Retinopathy
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-01
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03898973: Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
Official title: Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood
Acronym: FLU-LN
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Were not able to enroll participants
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-11
Primary completion date: 2023-11-17
Completion date: 2023-11-17
Plan to share individual participant data: NO
Clinical trial NCT03636269: CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension
Acronym: KALM-2
Sponsor: Cara Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 473.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-17
Primary completion date: 2020-03-30
Completion date: 2020-03-30
Plan to share individual participant data: NO
Clinical trial NCT03471286: A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
Official title: A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Deprioritization of drug in this patient population
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-06
Primary completion date: 2021-07-30
Completion date: 2021-07-30
Plan to share individual participant data: NO
Clinical trial NCT04829214: OTO-313 in Subjects With Unilateral Subjective Tinnitus
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
Sponsor: Otonomy, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-22
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT04250363: Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model
Official title: A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled PISPZ Challenge Model in Healthy Participants
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 10.0
Start date: 2020-02-17
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Baseline population: Safety analysis population (SAF) included all intent to treat (ITT) participants, who have been inoculated using a Direct Intravenous Inoculation (DVI) of PfSPZ and who were administered one dose of study intervention (M5717 or placebo). ITT population included all participants, who were randomized to study intervention.
Plan to share individual participant data: NO
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 the 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
Clinical trial NCT04898309: Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema
Official title: A Placebo-controlled Randomized Trial to Evaluate the Efficacy and Safety of GNR-038 in Comparison With Berinert® for Acute Attacks Relief in Patients With Hereditary Angioedema
Sponsor: AO GENERIUM (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Company pipeline revision
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-12-01
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT03387579: Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Official title: Comparison of Composite Lipid Emulsion Containing Fish Oil to Soy-based Lipid Reduction for Cholestasis Prevention in Neonates Requiring Abdominal Surgery
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-30
Primary completion date: 2021-03-28
Completion date: 2024-03-19
Plan to share individual participant data: NO
Clinical trial NCT04652765: Camostat With Bicalutamide for COVID-19
Official title: COMBO Trial: Camostat With Bicalutamide for COVID-19
Acronym: COMBO
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: PI Decision to close/stop the study due to no new accrual.
Enrollment: 6.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-02-03
Primary completion date: 2021-09-15
Completion date: 2021-09-15
Plan to share individual participant data: NO
Clinical trial NCT03630224: Plasmalyte Versus Saline in Trauma Patients
Official title: Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study)
Acronym: ASTRAU
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Premature termination due to futility following interim analysis
Enrollment: 365.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-24
Primary completion date: 2023-08-18
Completion date: 2023-08-18
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04987281: Robotic Bronchoscopy With Cone CT and Indocyanine Green to Aid Removal of Lung Lesions in Patients With Stage I Non-small Cell Lung Cancer or Lung Metastases, REPLACING Study
Official title: Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: 0 ACTUAL Enrollment must have Overall Recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-26
Primary completion date: 2023-12-27
Completion date: 2023-12-27
Clinical trial NCT03303066: Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
Official title: A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome
Sponsor: FibroGen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-06
Primary completion date: 2023-01-11
Completion date: 2023-02-08
Clinical trial NCT04128319: T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)
Official title: An Open-Label, Single-Arm, Multicenter Study, of Combination Anti-CD3/CD7 Immunotoxin (T-Guard) for Steroid-Refractory Acute Graft-versus-Host Disease)
Acronym: 1802
Sponsor: Xenikos (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Initiated a new randomized trial per discussion with FDA
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-21
Primary completion date: 2020-02-17
Completion date: 2020-02-17
Limitations and caveats: Due to the early trial closure and limited study population, only a subset of the protocol-specified planned analyses were performed.
Plan to share individual participant data: NO
Clinical trial NCT02901431: A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)
Official title: A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The 24-week analysis indicated no clinical or statistical benefit for the primary endpoint for the overall study population. No new safety concerns identified.
Enrollment: 339.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-11-21
Primary completion date: 2020-04-15
Completion date: 2020-06-30
Baseline population: PK Part \& Main Part reported separately. 7 patients (re-starters) are counted twice. PK review revealed age-adjusted doses of 4 \& 10 mg in 5-17 year olds weren't equivalent to target exposure. For Main Study Part, data was summarised by exposure ranges (tertiles) based on individual patients PK exposure at Week 12, estimated as average plasma concentration since treatment start. To allow clear analysis by exposure tertiles, patients with dose adjustment were excluded from analysis by tertiles.
Limitations and caveats: Study was terminated early, therefore, there was limited data collected in Open Label Extension part of the study.
Clinical trial NCT03829514: Fenofibrate in Type 2 Diabetes
Official title: Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-04
Primary completion date: 2020-03-04
Completion date: 2020-03-04
Clinical trial NCT03236805: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia
Official title: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial
Acronym: KETAMORPH
Sponsor: Nantes University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: 285 patients have recruited instead on 496 but we don't want to continue to prolonge the study. Analysis will be performed on the data we have.
Enrollment: 285.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-23
Primary completion date: 2022-11-26
Completion date: 2022-11-26
Plan to share individual participant data: NO
Clinical trial NCT05169710: A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
Official title: A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Sponsor: Sumitomo Pharma America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Company decided not to move forward with further accrual.
Enrollment: 83.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-21
Primary completion date: 2023-10-18
Completion date: 2023-10-18
Plan to share individual participant data: YES
IPD sharing description: IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data Site
IPD time frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.
Clinical trial NCT04353661: A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications
Official title: ¹²⁹XE MRI Assessment Of Disease Progression In Patients With Chronic Obstructive Pulmonary Disease Treated With Standard-of-Care Medications With Or Without Daily Open-Label Azithromycin Treatment To Prevent Acute Exacerbation
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated by Sponsor due to patient recruitment challenges.
Enrollment: 12.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-16
Primary completion date: 2023-06-29
Completion date: 2023-06-29
Clinical trial NCT03715829: A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Official title: A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 366.0 (ACTUAL)
Number of arms: 12.0
Start date: 2018-11-26
Primary completion date: 2021-02-05
Completion date: 2021-02-05
Baseline population: Baseline analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication).
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 NCT04757857: COVID-19 Antithrombotic Rivaroxaban Evaluation
Official title: Randomized, Pragmatic, Open Controlled Multicentre Study, Evaluating the Use of Rivaroxaban in Mild or Moderate COVID-19 Patients
Acronym: CARE
Sponsor: Hospital Alemão Oswaldo Cruz (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sustained reduction in the number of new COVID-19 cases as well as lower than expected event rates
Enrollment: 660.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-29
Primary completion date: 2022-08-08
Completion date: 2022-08-30
Plan to share individual participant data: NO
Clinical trial NCT03605342: Optimal Treatment of Veterans With PTSD and Comorbid OUD
Official title: Optimal Treatment of Veterans With PTSD and Comorbid Opiate Use Disorder (OUD)
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early termination
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2023-04-14
Completion date: 2023-04-14
Plan to share individual participant data: NO
Clinical trial NCT03301415: Asymptomatic Congenital CMV Treatment
Official title: A Phase II, Single Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants With Asymptomatic Congenital Cytomegalovirus Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Safety signal
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-21
Primary completion date: 2020-11-05
Completion date: 2020-11-05
Limitations and caveats: The trial was stopped early due to low accrual with only 7 participants enrolled.
Clinical trial NCT02052219: BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Sponsor: Anthera Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-31
Primary completion date: 2016-10-31
Completion date: 2021-10-31