chufangao/CTO huggingface dataset:
Clinical trial NCT03770767: Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Official title: A Randomised Controlled Trial Comparing the Effect of the Faster-acting Insulin Analog - Insulin Fiasp® - Versus Insulin Novorapid® in the Treatment of Women With Type 1 or Type 2 Diabetes During Pregnancy and Lactation. The Copen-fast Trial
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 216.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-11
Primary completion date: 2023-03-23
Completion date: 2023-03-23
Plan to share individual participant data: NO
IPD sharing description: Baseline data can be shared upon request.
Clinical trial NCT02136069: A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
Official title: Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Acronym: GARDENIA
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 397.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-12-24
Primary completion date: 2020-06-23
Completion date: 2020-06-23
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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 NCT04371393: MSCs in COVID-19 ARDS
Official title: Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: At 3d interim analysis, randomization, but not follow-up, was halted by the DSMB due to low predictive probability of achieving postulated mortality benefit (pre-specified 42.5% relative mortality reduction) were the trial to complete randomization.
Enrollment: 223.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2021-01-14
Completion date: 2022-01-02
Plan to share individual participant data: YES
IPD sharing description: All of the individual participant data collected during the trial, after deidentification.
IPD time frame: De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
IPD access criteria: Anyone who wishes to access the data.
Clinical trial NCT04254380: Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro
Official title: An Open-label, Randomized, Multicenter, Phase 3 Study to Compare the Immunogenicity, Efficacy, and Safety of Gan & Lee Insulin Lispro Injection to Humalog in Adult Subjects With Type 1 Diabetes Mellitus (T1DM)
Acronym: GENTL 1
Sponsor: Gan and Lee Pharmaceuticals, USA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: GanLee cancelled study -FDA Draft Guidance: Clinical Immunogenicity Considerations for Biosimilar \& Interchangeable Insulin Products released 11/25/2019
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-04
Primary completion date: 2020-01-27
Completion date: 2020-01-27
Plan to share individual participant data: NO
Clinical trial NCT05643573: A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
Official title: A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Prevention of Stroke or Systemic Embolism in Male and Female Participants Aged 18 Years and Older With Atrial Fibrillation at Risk for Stroke
Acronym: OCEANIC-AF
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Independent Data Monitoring Committee (IDMC) recommendation to stop the study
Enrollment: 14830.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-05
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT04398927: Systemic Chemotherapy Plus PD-1 for Metastasis ICC
Official title: Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: no patient enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-01
Primary completion date: 2021-01-01
Completion date: 2021-02-01
Clinical trial NCT01525069: Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma
Official title: Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Equipment that was used in the study was discontinued
Enrollment: 27.0 (ACTUAL)
Number of arms: 3.0
Start date: 2012-04-03
Primary completion date: 2018-08-08
Completion date: 2022-08-02
Plan to share individual participant data: NO
Clinical trial NCT03710161: Effect of Vitamin D Supplementation on Balance in CKD
Official title: Effect of Vitamin D Supplementation on Balance in Patients With Chronic Kidney Disease
Sponsor: University of Nebraska (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study was stopped due to the COVID pandemic
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-08
Primary completion date: 2020-03-13
Completion date: 2020-03-13
Plan to share individual participant data: NO
IPD sharing description: De -identified data will be published as supplementary data to manuscripts.
Clinical trial NCT04400890: Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
Official title: Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)
Sponsor: Mount Carmel Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Feasibility
Enrollment: 105.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-13
Primary completion date: 2021-03-01
Completion date: 2021-03-01
Baseline population: Between September 13, 2020 and December 11, 2020, 1,694 patients were telephoned within 24-h of testing positive for COVID-19 to be recruited into the clinical trial . One-hundred-five were enrolled and randomized. Five withdrew after receiving treatment packets (four withdrew before starting treatment and one withdrew after one treatment day citing too many pills as reason for withdrawal).
Limitations and caveats: The actual rate of primary and secondary COVID-19 outcome measures were lower than expected. Therefore the study plan had inadequate number of participants and was therefore under-powered.
Plan to share individual participant data: YES
Clinical trial NCT03514017: Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Official title: Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding unavailable
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-31
Primary completion date: 2023-05-16
Completion date: 2023-05-16
Clinical trial NCT04334174: Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas
Official title: A Phase II Single Arm Proof of Concept, Safety, Efficacy, Multicenter Study of Brentuximab Vedotin as Consolidation Therapy After Autologous Stem Cell Transplant in CD30 Expressing Peripheral T Cell Lymphomas
Acronym: BRENTICON-T
Sponsor: University of Kansas Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: accrual not met
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-29
Primary completion date: 2022-12-14
Completion date: 2023-02-01
Clinical trial NCT03503318: Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia
Acronym: RISE
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 544.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-27
Primary completion date: 2020-09-30
Completion date: 2020-12-03
Baseline population: Extended intent-to-treat (eITT) analysis set included all participants (adults and adolescents) randomized to the double-blind maintenance stage treatment, regardless if they had received treatment or not.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)
Clinical trial NCT03835286: Vitamin C to Reduce Vasopressor Dose in Septic Shock
Official title: Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
Acronym: ViCiS
Sponsor: Hospital Español de Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: COVID 19
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: YES
IPD sharing description: Complete database will be shared as requested by the publishing journal, once the study is completed
IPD time frame: Available one year after
IPD access criteria: Journal provided
Clinical trial NCT05820685: Dronabinol On the Pain Experience
Official title: Dronabinol On the Pain Experience (DOPE): a Pragmatic Randomized Clinical Trial
Acronym: DOPE
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Study paused because drug shortage
Enrollment: 664.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2023-07-27
Primary completion date: 2024-10-01
Completion date: 2024-10-30
Plan to share individual participant data: NO
Clinical trial NCT04132011: Dosing Intervals of Opioid Medication for Chronic Pain
Official title: Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No recruitment (Feasibility study).
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2020-03-08
Completion date: 2020-03-08
Plan to share individual participant data: NO
Clinical trial NCT03872128: The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Official title: The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 91.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-27
Primary completion date: 2022-11-01
Completion date: 2023-08-01
Baseline population: Data represented here is from participants that started treatment.
Clinical trial NCT03956862: GB001 in Adult Participants With Chronic Rhinosinusitis
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps
Sponsor: Gossamer Bio Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 97.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-16
Primary completion date: 2020-07-09
Completion date: 2020-08-05
Plan to share individual participant data: NO
Clinical trial NCT04166734: Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma
Official title: Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma
Acronym: MESO-PRIME
Sponsor: Royal Marsden NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to slow recruitment and insufficient further funding.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-26
Primary completion date: 2023-07-25
Completion date: 2023-07-25
Plan to share individual participant data: NO
Clinical trial NCT04480086: Safety and Tolerability Study of Mivebresib Tablet Alone or in Combination With Ruxolitinib Tablet or Navitoclax Tablet in Adult Participants With Myelofibrosis
Official title: A Phase 1b Study of Mivebresib Alone or in Combination With Ruxolitinib or Navitoclax in Subjects With Myelofibrosis
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 1.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-03-17
Primary completion date: 2023-07-28
Completion date: 2023-07-28
Plan to share individual participant data: NO
Clinical trial NCT03803774: Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma
Official title: Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Drug supply issues
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-25
Primary completion date: 2023-11-15
Completion date: 2023-12-29
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with National Institutes of Health (NIH) policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.~In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.~Requests for all collected individual participant data (IPD) data from clinical trials, conducted under a binding collaborative agreement between National Cancer Institute (NCI)/Division of Cancer Treatment and Diagnosis (DCTD) and a pharmaceutical/biotechnology company, that are not under Data and Safety Monitoring Board (DSMB) monitoring must be in compliance with the terms of the binding collaborative agreement and must be approved by NCI/DCTD and the Pharmaceutical Collaborator (i.e., the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) Director in conjunction with the NCI/DCTD Regulatory Affairs Branch).
Clinical trial NCT04043377: 68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
Official title: 68Ga-DOTATATE PET-CTA Imaging for the Early Detection of Progressing Coronary Atherosclerosis
Acronym: iPROGRESS
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Financial issues
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-21
Primary completion date: 2021-09-13
Completion date: 2021-09-13
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03601819: Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
Official title: Phase Ib, Open Label, Single Center Study of Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders
Sponsor: University of Michigan Rogel Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-15
Primary completion date: 2020-03-07
Completion date: 2020-07-17
Plan to share individual participant data: NO
Clinical trial NCT03972683: Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training
Official title: Novel Role of Acetylcholine in Regulating Vascular Tone: Effects of Age and Exercise Training
Sponsor: Colorado State University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: no participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-16
Primary completion date: 2021-07-31
Completion date: 2021-07-31
Plan to share individual participant data: NO
Clinical trial NCT02504333: Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma
Official title: A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Acronym: SEQUENCE
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 168.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-07-31
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Clinical trial NCT04206332: Trial to Evaluate CIS43LS in Healthy Adults
Official title: A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRC-MALMAB0100-00-AB (CIS43LS), in Healthy, Malaria-Naive Adults
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 71.0 (ACTUAL)
Number of arms: 17.0
Start date: 2020-01-07
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Baseline population: A total of 71 participants enrolled; however, 10 participants previously enrolled in Part A and who were later enrolled in Part B are counted twice (once in Part A and again in Part B).
Plan to share individual participant data: NO
IPD sharing description: Individual participant data (IPD) is not shared because it has limited value in a small phase 1 trial of healthy volunteers. We instead report non-IPD data as required in ClinicalTrials.gov.
Clinical trial NCT03848286: KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma
Official title: A Phase 2 Clinical Study To Evaluate the Efficacy and Safety of KL-A167 Injection in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 153.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-06
Primary completion date: 2021-07-13
Completion date: 2022-01-13
Plan to share individual participant data: NO
Clinical trial NCT05217472: An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS)
Official title: A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects With Moderately to Severely Active Primary Sjogren's Syndrome
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study canceled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-06
Primary completion date: 2022-04-15
Completion date: 2022-05-15
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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.