chufangao/CTO huggingface dataset:
Clinical trial NCT04034225: Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN
Official title: An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck
Sponsor: Sensei Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated by the sponsor
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-11
Primary completion date: 2021-06-28
Completion date: 2021-06-28
Limitations and caveats: The study stopped prematurely for lack of efficacy 25 patients were enrolled. Lab analyzes were not performed.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.
IPD time frame: Beginning 9 months and ending 36 months following article publication.
IPD access criteria: Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.
Clinical trial NCT03202537: Effectiveness of Physiologic Testing in PPI Non-Responders
Official title: Effectiveness of Physiologic Testing in PPI Non-Responders
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 240.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-01
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT03290196: The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Official title: The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Sponsor: Andrews Research & Education Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Patients pain was not regulated well with this product.
Enrollment: 60.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2015-09-03
Primary completion date: 2022-01-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT04409262: A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia
Official title: A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
Acronym: REMDACTA
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 649.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-16
Primary completion date: 2021-02-01
Completion date: 2021-03-08
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). 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 NCT04201821: Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women
Official title: Fecal Microbial Transplantation (FMT) For the Treatment of Fecal Incontinence in Women
Acronym: FMT for FI
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Administrative reasons
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-14
Primary completion date: 2023-01-18
Completion date: 2023-01-18
Plan to share individual participant data: NO
Clinical trial NCT02901041: Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
Official title: Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
Sponsor: Boston University Charles River Campus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-21
Primary completion date: 2022-01-04
Completion date: 2022-01-04
Plan to share individual participant data: NO
Clinical trial NCT05283304: Monthly Injectable BUP for MA Use Disorder (MURB) Trial
Official title: Randomized, Double-blind, Placebo-controlled Trial of Monthly Injectable Buprenorphine (BUP) for Methamphetamine (MA) Use Disorder
Acronym: CTN-0110
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Side effects of medication
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-24
Primary completion date: 2023-10-20
Completion date: 2023-11-19
Plan to share individual participant data: YES
IPD sharing description: Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants. The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the National Institute on Drug Abuse (NIDA) Data Share Agreement.
IPD time frame: After the study is complete and the data is analyzed
IPD access criteria: Study-specific de-identification notes will be posted on the website (URL provided here)
Clinical trial NCT04212026: Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer.
Official title: Irreversible Electroporation (IRE) Followed by Nivolumab in Patients With Metastatic Pancreatic Cancer: a Multicenter Single-arm Phase II Trial
Sponsor: University Hospital, Basel, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: difficult recruitement
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-28
Primary completion date: 2023-07-12
Completion date: 2023-07-12
Clinical trial NCT04115488: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®
Official title: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
Acronym: Antelope
Sponsor: Polpharma Biologics S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 265.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2021-08-23
Completion date: 2022-02-07
Baseline population: The Full Analysis Set (FAS) Population includes all patients who were randomized and have received at least one infusion of the study drug.
Plan to share individual participant data: NO
Clinical trial NCT03725033: Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Official title: Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Sponsor: Materia Medica Holding (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 538.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-10
Primary completion date: 2020-03-23
Completion date: 2020-03-23
Clinical trial NCT01759212: Left Ventricular Assist Device Combined With Allogeneic Mesenchymal Stem Cells Implantation in Patients With End-stage Heart Failure.
Official title: Safety and Efficacy of Intramyocardial Implantation of Allogeneic Mesenchymal Stem Cells in Patients With End-stage Heart Failure Undergoing Left Ventricular Assist Device Implantation
Sponsor: AHEPA University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Lack of eligible patients
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-10-31
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Clinical trial NCT03245970: Impedance Cardiography to Decrease the Risk of Preeclampsia
Official title: Use of Impedance Cardiography to Decrease the Risk of Preeclampsia
Sponsor: University of Tennessee Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Investigator retired. Other investigators did not want to continue study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-24
Primary completion date: 2020-02-29
Completion date: 2020-02-29
Plan to share individual participant data: NO
Clinical trial NCT02683941: Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
Official title: A Phase 3, Prospective, Randomized, Double-blind, Multi-center Study of the Efficacy and Safety of Lanreotide Autogel®/Depot 120 mg Plus BSC vs. Placebo Plus BSC for Tumour Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumours
Acronym: SPINET
Sponsor: Ipsen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: National Comprehensive Cancer Network \& European Neuroendocrine Tumor Society guidelines (2015/2016) led to prescription of somatostatin analogues (SSAs) in this setting, thereby limiting recruitment.
Enrollment: 77.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-06
Primary completion date: 2020-02-28
Completion date: 2020-02-28
Baseline population: The intention to treat (ITT) population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received.
Limitations and caveats: The majority of subjects who entered the open-label treatment phase were withdrawn due to study termination by the sponsor.
Clinical trial NCT04630067: Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427
Official title: A Phase Ia/b Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of AZD3427 in Healthy Volunteers and Multiple Ascending Doses of AZD3427 in Patients With Heart Failure (HFrEF and HF With EF ≥ 41%)
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 105.0 (ACTUAL)
Number of arms: 15.0
Start date: 2020-11-17
Primary completion date: 2022-09-14
Completion date: 2022-09-14
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04759365: Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Oral ASN51 in Healthy Subjects and Subjects With Alzheimer's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Oral ASN51 in Healthy Young Adult and Elderly Subjects and Elderly Subjects With Alzheimer's Disease
Sponsor: Asceneuron S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Delays with sites, identifying/enrolling patients, impact of COVID, staffing, and duration
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-02
Primary completion date: 2022-08-01
Completion date: 2022-08-01
Plan to share individual participant data: NO
Clinical trial NCT04178642: The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol
Official title: Hepatocellular Carcinoma Under 3 cm Treated by Percutaneous Tumor Destruction: Multicentric Phase 2 Test Evaluating the Impact of Adjuvant Chemotherapy by Intra-arterial Infusion of Idarubicin-lipiodol on the Hepatic Recurrence
Acronym: LIDA-ADJ
Sponsor: University Hospital, Montpellier (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: no participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-22
Primary completion date: 2021-07-14
Completion date: 2021-07-14
Plan to share individual participant data: NO
Clinical trial NCT03311334: A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors
Sponsor: Sumitomo Pharma America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision to terminate development of the program.
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-14
Primary completion date: 2022-10-19
Completion date: 2022-11-29
Clinical trial NCT03558958: Safety and Efficacy of P-188 NF in DMD Patients
Official title: An Exploratory, Open-label Study to Assess the Effect of P-188 NF (Carmeseal-MD) on Safety, on Respiratory and Cardiac Dysfunction and on Upper Limb Strength in Non-ambulatory Patients With Duchenne Muscular Dystrophy (DMD)
Sponsor: Phrixus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to lack of funding.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-08
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Plan to share individual participant data: NO
Clinical trial NCT04409886: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients
Official title: The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial
Acronym: HBOT
Sponsor: Maimonides Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: This study is part of a larger national study. Only 1 patient was enrolled at Maimonides; Medical Center. The study was ended by the sponsor because the PI left; funding ended; , and no time, or personnel to do the study
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-01
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
IPD sharing description: Data will not be shared
Clinical trial NCT02702115: Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I
Official title: A Phase I / 2, Multicenter, Open-label, Single-dose, Dose-ranging Study to Assess the Safety and Tolerability of SB-318, a rAAV2/6-based Gene Transfer in Subjects With Mucopolysaccharidosis I (MPS I)
Sponsor: Sangamo Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: All three subjects dosed in the study have rolled over to the Long-Term Follow-up Study IVPRP-LT01 (NCT04628871)
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-05-24
Primary completion date: 2021-11-03
Completion date: 2021-11-03
Baseline population: The original protocol anticipated 9-12 subjects in 3 cohorts at ascending doses. However, enrollment ended after 3 subjects were enrolled in 2 cohorts. (No subjects were enrolled in cohort 3). After interim data analysis, the sponsor decided to stop enrollment in this study at 3 subjects enrolled, all adults, in 2 cohorts. (No subjects were enrolled in cohort 3) The sponsor continues to monitor the subjects in a 10-year,follow-up study ST-IVPRP-LT01 (NCT04628871).
Limitations and caveats: Continuous data will be summarized using the following descriptive statistics: the number of subjects (n), mean, standard deviation (SD), median, minimum and maximum, where appropriate. Categorial percentage (%) of subjects for each category, where appropriate.
Clinical trial NCT03343847: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.
Official title: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Lymphomas
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study was not feasible
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-27
Primary completion date: 2021-07-17
Completion date: 2021-07-17
Clinical trial NCT03774251: A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy
Official title: A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Funding not secured
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2020-01-01
Completion date: 2021-01-01
Plan to share individual participant data: NO
Clinical trial NCT03720418: Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease
Official title: A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)
Acronym: SUNRISE-PD
Sponsor: Sio Gene Therapies (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: As a result of termination of development of OXB-102-01, it is no longer possible for Sio to either commence or to continue any related clinical trials.
Enrollment: 6.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-10-17
Primary completion date: 2022-04-12
Completion date: 2022-04-12
Plan to share individual participant data: NO
Clinical trial NCT03859908: Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries
Official title: Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery
Sponsor: Universidad de El Salvador (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulties for recruitment due to COVID-19 pandemia and expiration of the material
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-05
Primary completion date: 2021-01-27
Completion date: 2021-01-27
Plan to share individual participant data: NO
IPD sharing description: If we decide to share IPD, it will be: study protocol, statistical analysis. Criteria to share: for systematic reviews we could share also individual data collected, after the study is published.~The study was stopped for recruitment due to COVID-19 emergency and elective surgeries diminished, and then the product used expired. Couldn't achieve not even 2% of Sample size
Clinical trial NCT05107791: Effects of Stulln and Accommodative Training
Official title: Effects of Stulln Eye Drops and Accommodative Training on Accommodative Responses and Visual Fatigue
Sponsor: Pacific University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: unable to attend the drug for study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-15
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Plan to share individual participant data: NO
IPD sharing description: IPD will not be shared.
Clinical trial NCT03382639: A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia
Official title: A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia
Sponsor: Neurocrine Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 256.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-04
Primary completion date: 2020-12-29
Completion date: 2021-01-12
Baseline population: The Full Analysis Set (FAS) will included all participants who were randomized and received at least 1 dose of the study drug during the Double-Blind Treatment Period.
Plan to share individual participant data: NO
Clinical trial NCT04561960: Efficacy of Miswak in Oral Hygiene Maintenance
Official title: Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults
Sponsor: Riyadh Elm University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-30
Primary completion date: 2020-12-10
Completion date: 2020-12-30
Plan to share individual participant data: NO
Clinical trial NCT02895945: BAX 802 in CHA With Inhibitors
Official title: A Phase 3, Multicenter, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects With Congenital Hemophilia A With Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
Acronym: CHAWI
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Takeda has determined that the benefit/risk profile does not support continuation of the surgery Study for this specific Congenital Hemophilia A with Inhibitors patient population.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-22
Primary completion date: 2021-01-22
Completion date: 2021-01-22
Baseline population: SAS comprised of all participants who received any amount of BAX 802.
Limitations and caveats: Study was discontinued as Takeda determined that the benefit/risk profile did not support continuation of the surgery study for this specific Congenital Hemophilia A with Inhibitors participant population.
Plan to share individual participant data: NO
IPD sharing description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).