chufangao/CTO huggingface dataset:
Clinical trial NCT03863080: A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis Patients
Sponsor: Immunovant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-21
Primary completion date: 2020-10-07
Completion date: 2020-12-21
Baseline population: Safety Analysis Set (SAF) comprised of all participants who received at least 1 dose of study medication.
Plan to share individual participant data: NO
Clinical trial NCT04171843: A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma
Official title: A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma
Sponsor: Precision BioSciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study was terminated due to lack of sufficient therapeutic effect
Enrollment: 48.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-04-30
Primary completion date: 2022-10-19
Completion date: 2022-10-19
Clinical trial NCT02976038: Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
Official title: A Multicenter, Open-Label Phase 2 Extension Trial to Characterize the Long-term Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
Sponsor: Stealth BioTherapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Registration trial did not meet the primary end points
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-31
Primary completion date: 2020-03-09
Completion date: 2020-04-09
Baseline population: All participants for whom Baseline measurements were taken.
Plan to share individual participant data: NO
Clinical trial NCT03029871: Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer
Official title: Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Combination With Stereotactic Body Radiation Therapy (SBRT) in Clinical Stage 1/11A (T1A-T2B) Non-Small Cell Lung Cancer
Acronym: NSCLC
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No participants were enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-13
Primary completion date: 2018-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04502082: Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
Official title: An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-1)
Sponsor: Eureka Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Directing efforts to the pediatric study (ARYA-2) for this product
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-14
Primary completion date: 2023-06-20
Completion date: 2023-06-20
Plan to share individual participant data: NO
Clinical trial NCT05177796: Panitumumab and Pembrolizumab in Combination With Neoadjuvant Chemotherapy for the Treatment of Stage III-IV Triple Negative Breast Cancer
Official title: Enhancing Immunotherapy by Targeting the EGFR Pathway in Inflammatory Breast Cancer: A Phase II Study of Panitumumab (PmAb) and Pembrolizumab (Pembro) in Combination With Neoadjuvant Chemotherapy (NAC) in Patients With Newly Diagnosed Triple Negative Inflammatory Breast Cancer (TN-IBC)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: 0 participants recruited
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-11
Primary completion date: 2023-07-26
Completion date: 2023-07-26
Clinical trial NCT01774721: ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
Official title: ARCHER 1050: A RANDOMIZED, OPEN-LABEL, PHASE 3, EFFICACY AND SAFETY STUDY OF DACOMITINIB (PF-00299804) VERSUS GEFITINIB FOR THE FIRST LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER IN SUBJECTS WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) ACTIVATING MUTATION(S)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 452.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-05-09
Primary completion date: 2016-07-29
Completion date: 2022-01-27
Baseline population: ITT Population included all participants who were randomized, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or received a different treatment from that to which they were randomized.
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 NCT05024032: A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Official title: Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)
Acronym: SURMOUNT-CN
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 210.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-01
Primary completion date: 2022-12-27
Completion date: 2022-12-27
Baseline population: All participants who received at least one dose of study drug.
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 NCT04348916: Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors
Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of ONCR-177, an Oncolytic Herpes Simplex Virus for Intratumoral Injection, Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors
Sponsor: Oncorus, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated due to Oncorus portfolio reprioritization
Enrollment: 66.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-05-20
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT02507232: Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas
Official title: A Multicenter, Open-Label, Randomized Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas
Sponsor: Saint John's Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: low enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-17
Primary completion date: 2020-07-27
Completion date: 2020-07-27
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03418714: Effects of Salvinorin A on Brain Function
Official title: Effects of Salvinorin A on Brain Function
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-14
Primary completion date: 2020-03-02
Completion date: 2020-03-02
Plan to share individual participant data: NO
Clinical trial NCT04960202: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 2246.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-16
Primary completion date: 2021-12-09
Completion date: 2022-04-25
Baseline population: Full analysis set included all participants randomly assigned to study intervention, whether or not administered the study intervention.
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 NCT03181932: AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients
Sponsor: Savara Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 188.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-09-20
Primary completion date: 2020-07-28
Completion date: 2021-01-15
Baseline population: The number of baseline participants include both age groups (participants 6-21 years and \>21 years).
Limitations and caveats: A total of 200 participants were to be randomized. Consequent to the outbreak of COVID-19, the recruitment was stopped prematurely when 188 participants had been randomized.~The CFQ-R and CFRSD-CRISS were administered every two weeks using a hand-held e-Diary. The e-Diary had not been activated at the baseline visit for 39 participants. For these participants, missing baseline measurements were imputed with the population median baseline value for inferential analyses.
Plan to share individual participant data: NO
Clinical trial NCT02658396: GO-203-2C + Bortezomib For Relapsed Or Refractory MM
Official title: A Phase I Trial of the MUC1 Inhibitor, GO-203-2c, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study was never open due to lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Primary completion date: 2019-05-31
Completion date: 2022-01-31
Clinical trial NCT02917096: Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis
Official title: Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-11-13
Primary completion date: 2020-04-16
Completion date: 2023-08-31
Clinical trial NCT02864784: Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC
Official title: A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis
Sponsor: Amorphical Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Budget
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT03847896: A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma
Acronym: DENALI
Sponsor: Bond Avillion 2 Development LP (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1001.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-03-20
Primary completion date: 2021-07-20
Completion date: 2021-07-20
Baseline population: Of the 1,001 participants randomized, the full analysis set across all ages comprises 1,000 participants as one participant was randomized in error and did not receive study treatment. This participant has therefore been excluded from the summaries of baseline characteristics and efficacy.
Plan to share individual participant data: NO
Clinical trial NCT03763877: A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Sponsor: Poxel SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 121.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-03-29
Primary completion date: 2020-08-03
Completion date: 2020-08-10
Baseline population: Intent to treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.
Clinical trial NCT02640534: Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone
Official title: Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone (IMPROVE TRIAL): A Randomized, Open Label, Phase II Trial
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The decision is based on the fact that with the current follow up of around 10 years, the relevant secondary endpoints can adequately be addressed according to protocol. The addition of follow up data will not significantly impact these results.
Enrollment: 169.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-10
Primary completion date: 2022-07-01
Completion date: 2023-03-16
Plan to share individual participant data: NO
Clinical trial NCT04342325: The Clinical Trial of ADR-001 for IgA Nephropathy
Official title: Open-label, Multiple-center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 for the Treatment for Immunoglobulin A (IgA) Nephropathy
Sponsor: Nagoya University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-15
Primary completion date: 2022-11-01
Completion date: 2023-03-31
Plan to share individual participant data: NO
Clinical trial NCT03486834: V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)
Official title: Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 2200.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-30
Primary completion date: 2020-10-30
Completion date: 2021-06-30
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05486377: Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia
Official title: Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
Sponsor: Seoul National University Bundang Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 96.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-02
Primary completion date: 2023-05-19
Completion date: 2023-05-19
Clinical trial NCT04410042: Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure
Official title: Tranexamic Acid (TXA) to Reduce Volume Of Blood Transfused In Pediatric And Young Adult Cancer Patients Undergoing Limb Salvage Procedure Of A Lower Extremity
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Per sponsor
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-29
Primary completion date: 2024-01-16
Completion date: 2024-01-16
Plan to share individual participant data: YES
IPD sharing description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
IPD time frame: Data will be made available at the time of article publication.
IPD access criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Clinical trial NCT03294252: Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers
Official title: Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal)
Acronym: PIPOX
Sponsor: Institut Cancerologie de l'Ouest (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The 34 patients included had all completed their treatment period under the protocol and the data could be collected to assess the main objective and the secondary objectives before the last theoretical follow-up.
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-24
Primary completion date: 2019-02-05
Completion date: 2021-10-01
Clinical trial NCT02929394: Trabectedin Maintenance Post 1st-line in STS
Official title: Maintenance Therapy With Trabectedin Versus Observation After First Line Treatment With Doxorubicin of Patients With Advanced or Metastatic Soft Tissue Sarcoma.
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-07
Primary completion date: 2020-06-05
Completion date: 2020-06-05
Plan to share individual participant data: YES
IPD sharing description: All publications must comply with the terms specified in the EORTC Policy 009 Release of Results and Publication Policy.
Clinical trial NCT02012153: Mesenchymal Stromal Cells in Kidney Transplant Recipients
Official title: Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients
Sponsor: Mario Negri Institute for Pharmacological Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-12-04
Primary completion date: 2023-05-29
Completion date: 2023-05-29
Clinical trial NCT03739203: The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 752.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-10
Primary completion date: 2021-09-06
Completion date: 2021-09-06
Baseline population: Safety Population included all participants in the randomized population who took ≥1 dose of double-blind investigational product.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.