chufangao/CTO huggingface dataset:
Clinical trial NCT03846583: Tucatinib + Abemaciclib + Herceptin for HER2+ MBC
Official title: Phase Ib Trial of Tucatinib in Combination With Abemaciclib and Trastuzumab for Patients With HER2-Positive Metastatic Breast Cancer
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study halted prematurely, prior to enrollment of first participant.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-28
Primary completion date: 2020-09-22
Completion date: 2020-09-22
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT03099304: A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Official title: A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 157.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-06-07
Primary completion date: 2018-09-12
Completion date: 2021-09-08
Plan to share individual participant data: NO
Clinical trial NCT05542095: Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia
Official title: Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia
Acronym: SimCA
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study halted prematurely; IRB approval not obtained
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-05-01
Primary completion date: 2023-05-01
Completion date: 2023-05-01
Plan to share individual participant data: NO
Clinical trial NCT02574078: A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)
Acronym: CheckMate370
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 341.0 (ACTUAL)
Number of arms: 10.0
Start date: 2015-11-23
Primary completion date: 2020-04-15
Completion date: 2020-04-15
Clinical trial NCT04535102: POLA+BR for Relapsed or Refractory DLBCL
Official title: POLATUZUMAB PLUS BENDAMUSTINE PLUS RITUXIMAB (POLA+BR) AS SALVAGE THERAPY PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANT FOR PATIENTS WITH RELAPSED OR PRIMARY REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of sufficient patient population
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-29
Primary completion date: 2022-03-17
Completion date: 2022-03-17
Plan to share individual participant data: NO
Clinical trial NCT06007508: Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis
Official title: Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis
Sponsor: HealthPartners Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study intervention was adopted as standard of care.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-31
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share IPD with investigators not currently involved in the study.
Clinical trial NCT04154293: A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Official title: A Randomized, Parallel, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Two Concentrations of Topical TMB-001 for the Treatment of Congenital Ichthyosis
Sponsor: Timber Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-03
Primary completion date: 2021-08-20
Completion date: 2021-08-30
Baseline population: All subjects who received at least one dose of study drug (TMB-001 0.1% or TMB-001 0.05%) or vehicle
Limitations and caveats: small sample size. study not powered for statistical significance.
Clinical trial NCT01690702: Study of Nab-Paclitaxel in High Risk Early Breast Cancer
Official title: Neo-/Adjuvant Phase III Trial to Compare Intense Dose-dense Chemotherapy to Tailored Dose-dense Chemotherapy in Patients With High-risk Early Breast Cancer (GAIN-2)
Acronym: GAIN-2
Sponsor: German Breast Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2886.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-09-30
Primary completion date: 2018-09-30
Completion date: 2020-07-20
Clinical trial NCT04702698: Effect of Food on Peposertib PK
Official title: Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-01-14
Primary completion date: 2021-03-03
Completion date: 2021-03-03
Plan to share individual participant data: NO
IPD sharing description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients 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 https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Clinical trial NCT05100160: Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Official title: Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: 0 patient accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-15
Primary completion date: 2023-01-03
Completion date: 2023-01-03
Clinical trial NCT02505087: Pharmacological Treatment of a Rare Genetic Disease: N-acetylcysteine in Myopathy Associated Selenoprotein N-related Myopathy (SEPN1-RM)
Official title: Pharmacological Treatment of a Rare Genetic Disease: Pilot Trial Phase II-III With N-acetylcysteine in Myopathy Associated SEPN1-RM (Selenoprotein N-related Myopathy)
Acronym: SelNac
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Enrollment: 7.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-09-30
Primary completion date: 2018-04-24
Completion date: 2020-08-31
Clinical trial NCT05172050: Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.
Official title: Multicenter, Adaptive, Randomized, Placebo-controlled, Double Blind, Parallel-group Phase 2/3 Trial, to Study Efficacy and Safety of Two Doses of Raloxifene in Adult Paucisymptomatic COVID-19 Patients.
Sponsor: Dompé Farmaceutici S.p.A (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-22
Primary completion date: 2021-06-12
Completion date: 2021-06-12
Baseline population: The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for demographics, and primary and secondary efficacy analyses
Plan to share individual participant data: NO
Clinical trial NCT02256436: A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)
Official title: A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 542.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-22
Primary completion date: 2016-09-07
Completion date: 2020-10-01
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04580407: Study of TAK-672 in Participants With Acquired Hemophilia A
Official title: A Phase 2/3, Open-Label, Non-controlled Study to Evaluate the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in the Treatment of Serious Bleeding Episode in Japanese Subjects With Acquired Hemophilia A (AHA)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-09
Primary completion date: 2022-11-29
Completion date: 2022-11-29
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 NCT03300505: ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer
Official title: ARRO-CITO: (UMCC 2017.055) Phase Ib/II Single-Arm Multi-Center Study of IONIS-AR-2.5Rx, a Next Generation Androgen Receptor Antisense Oligonucleotide, in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer
Sponsor: University of Michigan Rogel Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Cancelled by the sponsor
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-31
Primary completion date: 2023-01-24
Completion date: 2023-01-24
Plan to share individual participant data: NO
Clinical trial NCT02973295: Silymarin in NAFLD
Official title: Silymarin® - Efficacy in Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) Controlled by Laboratory and and Elastographic Parameters
Acronym: SINF
Sponsor: University Hospital Rijeka (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Sponsor withdrawn their agreement
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-20
Primary completion date: 2020-12-31
Completion date: 2021-06-30
Plan to share individual participant data: YES
IPD sharing description: All patient data will be available to other researchers after interim analysis
Clinical trial NCT03316118: US Guided GNB vs Saline Injection for TKA
Official title: A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low Enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-05
Primary completion date: 2021-06-21
Completion date: 2021-06-21
Baseline population: Study terminated early due to low enrollment.
Limitations and caveats: The limitation to the results is that the study was terminated early for low enrollment.
Plan to share individual participant data: NO
Clinical trial NCT04493424: A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Official title: An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 108.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-04
Primary completion date: 2023-01-16
Completion date: 2023-05-15
Baseline population: The safety analysis set for maintenance treatment (SAF-MT): Included all patients who received at least one dose of the maintenance treatment Spesolimab (BI 655130).
Limitations and caveats: The trial was prematurely discontinued due to the sponsor's (Boehringer Ingelheim) decision to terminate the clinical program studying spesolimab in patients with PPP. This decision was not based on any safety finding in the clinical trials.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT04187547: A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension
Official title: A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease and Who Are Noncarriers of the APOE4 Allele
Sponsor: Cerecin (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study replaced with a new study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2023-12-31
Completion date: 2024-02-28
Clinical trial NCT02684617: Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155/KEYNOTE-155)
Official title: Phase Ib Trial of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Subjects With Hematologic Malignancies (KEYNOTE-155).
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 75.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-03-29
Primary completion date: 2020-04-06
Completion date: 2020-04-06
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05286567: A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.
Official title: An Investigator Initiated, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Suppurativa
Sponsor: Aarhus University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2022-08-29
Completion date: 2022-08-29
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02841579: Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M
Official title: A Phase IIa Clinical Trial to Evaluate the Safety and Efficacy of Osimertinib (AZD9291) in First-line Patients With EGFR Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer and Concomitant EGFR T790M Mutation at Time of Diagnosis
Acronym: AZENT
Sponsor: MedSIR (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-31
Primary completion date: 2018-12-31
Completion date: 2020-02-29
Plan to share individual participant data: NO
Clinical trial NCT03550443: A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study
Official title: RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Based on results of double-blind parts, it was determined that it would be difficult to submit a marketing authorization application for RTA 402 for diabetic kidney disease.
Enrollment: 1323.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-30
Primary completion date: 2022-11-30
Completion date: 2023-07-31
Plan to share individual participant data: NO
Clinical trial NCT03481842: Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
Official title: Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
Acronym: ELTA
Sponsor: BioGene Pharmaceutical Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Change in study design and sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-10
Primary completion date: 2021-10-10
Completion date: 2021-10-10
Clinical trial NCT02038777: A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913 (GLASDEGIB), AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS A SINGLE AGENT IN JAPANESE PATIENTS WITH SELECT HEMATOLOGIC MALIGNANCIES AND IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW-DOSE ARA-C, OR AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 6.0
Start date: 2014-03-25
Primary completion date: 2021-02-12
Completion date: 2023-12-28
Baseline population: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.
Plan to share individual participant data: NO
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 NCT04140539: A Clinical Study to Enable Process Validation of Commercial Grade OTL-101
Official title: A Single Arm, Open Label Clinical Study to Enable Process Validation of Commercial Grade Ex Vivo Hematopoietic Stem Cell Gene Therapy (OTL-101) in Subjects With Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency (ADA-SCID)
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Recruitment on hold for business reasons. Study will not be performed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-15
Primary completion date: 2021-08-30
Completion date: 2021-08-30
Plan to share individual participant data: NO
Clinical trial NCT04294459: Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation
Official title: A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated due to non-safety reasons
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-18
Primary completion date: 2022-05-02
Completion date: 2022-05-02
Baseline population: Analysis was performed on all enrolled participants.
Limitations and caveats: Sponsor decided to terminate the study for non-safety reasons on 02 May 2022. Based on available clinical data at time of interim analysis, it was determined that enrollment of the remaining participants was unlikely to have any significant impact on the study results and hence the trial was stopped. All 23 participants enrolled in the study were followed-up per protocol until the planned study termination date.
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 clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org