chufangao/CTO huggingface dataset:
Clinical trial NCT05794672: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects
Official title: A Phase 1, Randomised, Single-blind, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Elarekibep Given Twice Daily as Inhaled or a Single IV Formulation in Healthy Japanese Subjects
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-11
Primary completion date: 2023-07-08
Completion date: 2023-07-08
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 NCT03139604: GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Official title: GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 439.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-19
Primary completion date: 2019-05-02
Completion date: 2020-07-13
Plan to share individual participant data: NO
Clinical trial NCT03525392: Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.
Official title: An International Multicentre, Open-Label First in Human Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Antitumour Activity of 177Lu-3BP-227 for the Treatment of Subjects With Solid Tumours Expressing Neurotensin Receptor 1
Sponsor: Ipsen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to agreement to transfer rights for IPN01087 to an external partner, not due to safety concerns
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-03
Primary completion date: 2020-04-03
Completion date: 2021-04-28
Baseline population: Included population contained all screened participants who were included in the study and received the therapeutic dose.
Limitations and caveats: The sponsor terminated the study early and phase 1 dose expansion and phase 2 were not started. The decision to terminate the study was not due to any safety or tolerability concern, or any event associated with the use of 177Lu-3BP-227.
Clinical trial NCT04655027: A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
Official title: ALTAI: An Open-Label, Randomized, Active-Controlled, Parallel Design, Multicenter Phase IV Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-22
Primary completion date: 2021-10-12
Completion date: 2021-10-12
Baseline population: The Full analysis Set (FAS) was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis.
Limitations and caveats: * NDD randomization strata were merged because recruitment was insufficient.~* The log-transform of AUC was removed from the primary assessment post-database-lock when negative AUC were discovered (which invalidated log-transformation).
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 deidentified 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 NCT03689829: A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis
Official title: A Parallel-design Phase 1 Study to Assess Safety, Tolerability and Pharmacokinetics/Exposure Following Different Single Dose Levels of MOR106 (Administered Subcutaneously or Intravenously) in Healthy Male Subjects (Randomized, Open-label), and in Subjects With Moderate to Severe Atopic Dermatitis (Randomized, Placebo-controlled, Double-blind, Repeated Subcutaneous Dosing Over 12 Weeks)
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: MOR106 clinical development in atopic dermatitis was stopped for futility
Enrollment: 44.0 (ACTUAL)
Number of arms: 8.0
Start date: 2018-08-13
Primary completion date: 2020-03-02
Completion date: 2020-03-02
Clinical trial NCT04145700: CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
Official title: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated for meeting protocol specified futility criteria.
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-04
Primary completion date: 2023-02-23
Completion date: 2023-02-23
Baseline population: All randomized participants.
Limitations and caveats: The limitation to this study was the highly varied estimates of the PFS HR and the probability of PFS HR \< 1 due to influence from the matched historical controls whose PFS substantially outperformed PFS from the prospectively randomized control.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04187508: A Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen
Official title: A Phase IIa, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Multi-Centre Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily on Allergen-Induced Inflammation in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The reason is: emerging pre-clinical toxicology findings.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-06
Primary completion date: 2021-11-10
Completion date: 2021-11-10
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 request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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 deidentified 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 NCT02519140: Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Official title: Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Sponsor: Maimonides Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-08-01
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Clinical trial NCT03845140: L-PZQ ODT in Schistosoma Infected Children
Official title: An Open Label, Phase III Efficacy and Safety Study of L-PZQ ODT in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide®)
Sponsor: Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 288.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-09-02
Primary completion date: 2021-10-11
Completion date: 2021-10-11
Baseline population: Safety analysis population (SAF) included all participants who received 1 dose of study treatment.
Plan to share individual participant data: YES
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 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
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT04049266: A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Official title: A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.
Acronym: DAZZLE
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Primary Endpoint Not Met
Enrollment: 559.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-08
Primary completion date: 2021-11-17
Completion date: 2022-04-26
Baseline population: All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept)
Limitations and caveats: This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment.
Plan to share individual participant data: NO
Clinical trial NCT04687137: Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema
Official title: Open-arm, Japan Expanded Access Program With Lanadelumab (TAK-743) for Japanese Patients With Hereditary Angioedema
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-10
Primary completion date: 2022-06-18
Completion date: 2022-06-18
Baseline population: Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug.
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/study sites).
Clinical trial NCT04933383: Crossover Trial to Assess Efficacy and Safety of Inhaled AQ001S Compared to a Budesonide Suspension in Mild Asthmatics
Official title: A Prospective, Active-controlled, Randomized, Open Label, Single-center, Multiple Dose, Crossover Clinical Trial to Assess the Efficacy, Safety and PK of AQ001S Compared to a Budesonide Inhalation Suspension in Adults With Mild Asthma
Acronym: BOREAS
Sponsor: Aquilon Pharmaceuticals S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-23
Primary completion date: 2022-12-31
Completion date: 2023-01-31
Baseline population: The efficacy population encompasses all subjects that completed both treatment periods and for which the primary efficacy parameters PC20 is available at baseline (visit 1) and after both treatment periods (visit 2 and visit 4).~The safety population includes all randomized subjects who received at least one dose of the study medication (AQ001S or comparator).
Limitations and caveats: No limitations or caveat are reported for this trial.
Plan to share individual participant data: NO
Clinical trial NCT03318523: Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
Acronym: SPARK
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: SPARK did not meet it's primary outcome measure for year 1 and failed to meet secondary outcome measures resulting in the development of BIIB054 (cinpanemab) for Parkinson's disease to be discontinued and SPARK study was closed.
Enrollment: 357.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-10
Primary completion date: 2020-10-26
Completion date: 2021-04-29
Baseline population: Intent-to-treat (ITT) population was defined as all randomized participants who received at least one dose of study treatment (BIIB054 or placebo).
Limitations and caveats: The study did not meet its primary outcome measure for year 1 and did not demonstrate efficacy on key secondary outcome measures; additional pre-specified analyses at week 72 confirmed the study did not provide evidence of efficacy; resulting in the development of BIIB054 for Parkinson's disease to be discontinued and SPARK study was closed.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Clinical trial NCT04921969: A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)
Official title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 330.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-07-19
Primary completion date: 2023-05-10
Completion date: 2024-04-08
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT05359874: Improvement of the Operative Outcome in Patients With Primary VEGF + Unifocal Breast Cancer or DCIS Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Bevacizumab-IRDye-800CW
Official title: Improvement of the Operative Outcome in Patients With Primary VEGF Positive Unifocal Breast Cancer or Ductal Carcinoma in Situ (DCIS) Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Fluorescent Markers Bevacizumab-IRDye-800CW
Acronym: DoT-FMI
Sponsor: Technical University of Munich (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: application has been withdrawn
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-30
Primary completion date: 2023-03-31
Completion date: 2023-03-31
Plan to share individual participant data: UNDECIDED
IPD sharing description: no patient specific data will be shared
Clinical trial NCT03359785: A Study to Evaluate Multiple Oral Doses of Luvadaxistat in Adults With Schizophrenia
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of TAK-831 in Adult Subjects With Schizophrenia
Sponsor: Neurocrine Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-10
Primary completion date: 2020-12-21
Completion date: 2020-12-21
Baseline population: The safety analysis set included all participants who were randomized and received at least 1 dose of double-blind study drug.
Plan to share individual participant data: NO
Clinical trial NCT03377699: Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
Official title: A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes
Acronym: EXPECT
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 225.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-22
Primary completion date: 2020-12-17
Completion date: 2020-12-17
Baseline population: FASall: included all randomised women contributed to the evaluation.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04452435: Safety and Efficacy of C21 in Subjects With COVID-19
Official title: A Randomised, Double-blind, Placebo-controlled, Phase 2 Trial Investigating the Safety and Efficacy of C21 in Hospitalised Subjects With COVID-19 Infection Not Requiring Mechanical Ventilation
Sponsor: Vicore Pharma AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 206.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-21
Primary completion date: 2020-10-13
Completion date: 2020-10-13
Clinical trial NCT04162769: A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (With a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Acronym: ADVISE
Sponsor: Arena Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 140.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-04
Primary completion date: 2020-09-09
Completion date: 2021-10-11
Baseline population: Full Analysis Set (FAS) included all randomized participants, irrespective of whether they received any study intervention.
Plan to share individual participant data: NO
Clinical trial NCT01062425: Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma
Official title: Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 261.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-02-26
Primary completion date: 2015-12-06
Completion date: 2022-05-20
Baseline population: All randomized and eligible patients.