chufangao/CTO huggingface dataset:
Clinical trial NCT03566303: Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis
Official title: Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis
Acronym: RIWA
Sponsor: Hospital Geral Roberto Santos (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Coronavirus Pandemic
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-10
Primary completion date: 2020-04-26
Completion date: 2020-04-26
Plan to share individual participant data: NO
Clinical trial NCT04002115: Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML
Official title: Clofarabine Pre-conditioning Followed by Hematopoietic Stem Cell Transplant With Post-Transplant Cyclophosphamide for Non-remission Acute Myeloid Leukemia
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: terminated due to low accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-03
Primary completion date: 2022-08-30
Completion date: 2022-11-07
Limitations and caveats: Due to slow accrual, the study was terminated.
Plan to share individual participant data: NO
IPD sharing description: At this time there is no plan to share IPD with other researchers outside of Penn State University
Clinical trial NCT04479436: A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer
Official title: A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated early given the Interim Analysis for Part 1 (signal finding) did not meet pre-specified criteria and will not proceed to Part 2. Sponsor will proceed closing the study.
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-14
Primary completion date: 2022-02-03
Completion date: 2022-02-03
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT01490502: Vitamin D Supplementation in Multiple Sclerosis
Official title: A Randomized Controlled Trial of Vitamin D Supplementation in Multiple Sclerosis
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 172.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-03-31
Primary completion date: 2021-05-15
Completion date: 2021-05-15
Clinical trial NCT03304054: Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG
Official title: A Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients
Sponsor: Catalyst Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-18
Primary completion date: 2020-01-31
Completion date: 2020-03-15
Baseline population: The analysis of baseline characteristics included all patients in the Safety population, who are those patients who enrolled and received at least one dose of amifampridine. Patients who began the run-in period belong to the Safety population whether they were randomized to treatment or not.
Plan to share individual participant data: NO
Clinical trial NCT02075047: Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
Official title: A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on recent input from FDA, the pre-specified final analysis will be performed at the current enrollment using a re-estimation of the sample size.
Enrollment: 171.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-05-23
Primary completion date: 2020-04-11
Completion date: 2020-05-18
Baseline population: The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo).
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 NCT02596555: Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.
Official title: Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism
Acronym: PEITHO-2
Sponsor: Johannes Gutenberg University Mainz (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: 1. Interim results suggested a reduction of sample size.~2. Anticipated length of enrolment period with resulting funding issues to pose a threat to the study.
Enrollment: 400.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-01-31
Primary completion date: 2020-02-29
Completion date: 2020-02-29
Clinical trial NCT03690739: Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer
Official title: Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer
Sponsor: AGO Research GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient Recruitment
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-09
Primary completion date: 2021-03-03
Completion date: 2021-03-03
Clinical trial NCT05388279: A Clinical Study to Evaluate the Safety and Tolerability of JS012 in Advanced or Metastatic Solid Tumors
Official title: A Phase I Clinical Study Evaluating the Safety ,Tolerability, Pharmacokinetics of JS012 in Patients With Advanced or Metastatic Solid Tumors
Sponsor: Shanghai Junshi Bioscience Co., Ltd. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the adjustment and change of the sponsor's R\&D strategy, we now plan to voluntarily terminate this clinical trial.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-28
Primary completion date: 2022-09-19
Completion date: 2022-09-19
Clinical trial NCT05864391: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH.
Official title: A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Ascending Dose Administration to Patients With Suspected Non-cirrhotic Non-alcoholic Steatohepatitis (NASH)
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: AstraZeneca have decided to not move forward with the development of the compound.
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-31
Primary completion date: 2024-03-20
Completion date: 2024-03-20
Clinical trial NCT00515554: HD18 for Advanced Stages in Hodgkins Lymphoma
Sponsor: University of Cologne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1500.0 (ACTUAL)
Number of arms: 4.0
Start date: 2008-05-31
Primary completion date: 2019-07-31
Completion date: 2020-07-31
Clinical trial NCT04096820: Uromune in Treating Recurrent Urinary Tract Infections in Women
Official title: Protocol 19-01: Canadian, Single Centre, Pilot, Open Label Study to Evaluate the Efficacy and Safety of the Bacterial Vaccine Uromune in Treating Recurrent Urinary Tract Infections in Women.
Sponsor: Queen's University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Convenience sample based on available funding. Increased Covid-related costs of clinical research resulted in early termination
Enrollment: 67.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-06
Primary completion date: 2022-10-31
Completion date: 2023-01-01
Baseline population: The study was terminated because of Covid related delay and problems with enrollment as well as cost considerations (funds ran out).
Clinical trial NCT01602861: The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity
Official title: The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity
Acronym: SPIREN
Sponsor: Odense University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 188.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-02-28
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Clinical trial NCT02947165: Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.
Official title: A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-25
Primary completion date: 2021-06-18
Completion date: 2021-06-18
Plan to share individual participant data: NO
Clinical trial NCT02721654: Plasma-Lyte 148® versUs Saline Study
Official title: Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults
Acronym: PLUS
Sponsor: The George Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 5037.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-01
Primary completion date: 2021-03-30
Completion date: 2021-06-30
Plan to share individual participant data: YES
Clinical trial NCT05466240: Study of AT-752 in Patients With Dengue Infection
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of AT-752 in Patients With Dengue Infection
Sponsor: Atea Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision to deprioritize the dengue program
Enrollment: 21.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-04-29
Primary completion date: 2023-01-19
Completion date: 2023-01-19
Limitations and caveats: Early discontinuation leading to small numbers of subjects analyzed.
Clinical trial NCT02054806: Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
Official title: Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 477.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-02-17
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Baseline population: The analysis population consisted of all allocated participants who received at least one dose of study drug. Per protocol, Baseline Characteristics were summarized by treatment dose.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02569801: A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Official title: A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy
Acronym: HydranGea
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.
Enrollment: 71.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-04
Primary completion date: 2020-02-28
Completion date: 2020-02-28
Clinical trial NCT05180500: Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
Official title: Phase 1 Clinical Trial of a Q GRFT Nasal Spray
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-15
Primary completion date: 2022-12-07
Completion date: 2022-12-07
Baseline population: All randomized participants
Plan to share individual participant data: NO
Clinical trial NCT04939987: Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy
Official title: Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: PI left institution and study was not transferred to new PI
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-31
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT02773849: ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Official title: A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High-Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Sponsor: Ferring Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 157.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-09-19
Primary completion date: 2019-05-24
Completion date: 2023-05-24
Plan to share individual participant data: NO
Clinical trial NCT03777436: An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Acronym: DISCREET
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 289.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-11
Primary completion date: 2021-09-23
Completion date: 2022-02-09
Baseline population: The intent-to-treat (ITT) analysis set consisted of all participants who are randomized regardless of whether the participant received investigational product (IP).
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT03523715: Prunes for Gastrointestinal Function After Gynecologic Surgery
Official title: Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulty in recruiting participants
Enrollment: 77.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-30
Primary completion date: 2020-06-30
Completion date: 2020-07-31
Plan to share individual participant data: NO
Clinical trial NCT05454709: A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System
Official title: A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study
Acronym: STABLE-1
Sponsor: Inreda Diabetic B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study medication could not be delivered by manufacturer.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-12-29
Primary completion date: 2023-12-29
Completion date: 2023-12-29
Plan to share individual participant data: NO
Clinical trial NCT02907177: Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Official title: Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Acronym: POINT
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: sponsor decision due to low recruitment
Enrollment: 136.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-30
Primary completion date: 2020-03-26
Completion date: 2020-03-26
Baseline population: Randomized Analysis Set included all participants who were randomized in this study.
Limitations and caveats: Due to slow recruitment rate the study was considered futile by the Independent Data Monitoring Committee and the sponsor agreed to prematurely terminate the study. Due to this premature termination of study, the insufficient sample size did not allow to detect the differences for the main efficacy endpoints. The safety profile of ponesimod as add-on to DMF therapy could not be fully characterized due to limited data.
Clinical trial NCT02807636: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Acronym: IMvigor130
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1213.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-06-30
Primary completion date: 2022-08-31
Completion date: 2024-02-12
Clinical trial NCT04221256: Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity
Official title: Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity
Sponsor: Burke Medical Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Closure due to COVID-19 pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-11
Primary completion date: 2021-02-09
Completion date: 2021-02-09
Plan to share individual participant data: NO
Clinical trial NCT03496519: Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors
Official title: A Phase I Study Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Contract Issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Clinical trial NCT03285087: Risk Prediction of Dexmedetomidine-associated Hemodynamic Instability
Official title: Risk Prediction and Consequences of Dexmedetomidine-associated Hemodynamic Instability in Intubated Mechanically Ventilated Intensive Care Unit Patients
Acronym: DEXSEDATION
Sponsor: Assiut University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: dexmedetomidine is unavailable in this time
Enrollment: 250.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2021-06-30
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Plan to share individual participant data: NO
Clinical trial NCT04735432: Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Official title: A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis
Acronym: ADAPTsc
Sponsor: argenx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 110.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-05
Primary completion date: 2021-11-02
Completion date: 2021-12-13
Baseline population: ITT analysis set: All randomized participants who were exposed to the IMP. mITT analysis set: All randomized participants with a value for total IgG levels at baseline and at least 1 postbaseline time point. Safety analysis set: All randomized participants who were exposed to IMP. PK analysis set: A subset of the safety analysis set with at least 1 post dose PK measurement.
Limitations and caveats: None reported.
Plan to share individual participant data: NO