chufangao/CTO huggingface dataset:
Clinical trial NCT03019120: Vitamin D Supplementation and Neurocognition
Official title: The Effect of Vitamin D Supplementation on Neurocognitive Function in Older Subjects
Acronym: Dcog
Sponsor: Rambam Health Care Campus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to administrative reasons, it was not possible to enroll subjects.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-15
Primary completion date: 2020-02-24
Completion date: 2020-02-24
Plan to share individual participant data: NO
Clinical trial NCT03880487: A Single and Multiple Ascending Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of KP-1199
Official title: A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199
Sponsor: Kalyra Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The Study was terminated early by sponsor
Enrollment: 26.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-12
Primary completion date: 2020-04-21
Completion date: 2020-04-21
Clinical trial NCT05100628: A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
Official title: A Dose Escalation and Dose Expansion Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma - CEP-2
Sponsor: Noxopharm Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 10.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-02-11
Primary completion date: 2023-05-01
Completion date: 2023-05-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03067571: Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Official title: An Open-Label, Phase 2 Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplastic Syndrome
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated early because of lack of efficacy
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-27
Primary completion date: 2022-11-21
Completion date: 2022-11-21
Clinical trial NCT00555399: Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)
Official title: Phase I / II Adaptive Randomized Trial of Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: No Sponsor funding for continuation of trial
Enrollment: 55.0 (ACTUAL)
Number of arms: 5.0
Start date: 2007-11-28
Primary completion date: 2020-01-24
Completion date: 2020-01-24
Baseline population: Data provided for the demographics of participants enrolled into each arm is not related to the treatment cohorts but to the combination of agents used.
Clinical trial NCT03510897: QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Official title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Sponsor: Quark Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.
Enrollment: 1043.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-29
Primary completion date: 2020-10-14
Completion date: 2021-04-12
Clinical trial NCT03442088: Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
Official title: An Investigator Initiated Study of Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
Sponsor: University Hospitals Cleveland Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-01
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT02855164: Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
Official title: A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR
Acronym: FLIGHT-FXR
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Enrollment: 350.0 (ACTUAL)
Number of arms: 8.0
Start date: 2016-08-01
Primary completion date: 2020-04-06
Completion date: 2020-04-06
Baseline population: Full analysis set (FAS) was all subjects to whom study treatment had been assigned. Following the intent-to-treat (ITT) principle, subjects were analyzed according to the treatment they have been assigned to at randomization.
Limitations and caveats: No outputs were planned; and are not available for determining the effects of tropifexor on primary endpoints in the subset of patients who had historical biopsy data.
Plan to share individual participant data: UNDECIDED
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT02215876: Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
Official title: A Phase II (Single Center) Study of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No patients recruited.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-09-30
Primary completion date: 2017-08-31
Completion date: 2020-03-31
Clinical trial NCT04241068: A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Official title: Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor's Decision
Enrollment: 1696.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-02
Primary completion date: 2024-07-22
Completion date: 2024-07-22
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT05604287: Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
Official title: A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants
Sponsor: IlDong Pharmaceutical Co Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor have decided to cancel the trial
Enrollment: 67.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-10-10
Primary completion date: 2024-04-12
Completion date: 2024-04-12
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03683719: Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
Official title: A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema
Sponsor: LEO Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 258.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-11-28
Primary completion date: 2020-03-06
Completion date: 2020-04-20
Plan to share individual participant data: YES
IPD access criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Clinical trial NCT03800784: Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Official title: Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-01
Primary completion date: 2021-10-21
Completion date: 2021-10-21
Plan to share individual participant data: NO
Clinical trial NCT03869684: A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
Official title: A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of MT-0814 for the Treatment of Patients With Age-Related Macular Degeneration
Sponsor: Senju Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study terminated for safety reasons
Enrollment: 13.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-25
Primary completion date: 2020-03-25
Completion date: 2020-04-24
Limitations and caveats: All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.
Plan to share individual participant data: NO
Clinical trial NCT03739801: MM-398 and Ramucirumab in Treating Patients With Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Official title: Phase I/II Study of MM-398 in Combination With Ramucirumab After Platinum Failure in Gastric Cancer
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: PI left
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-06
Primary completion date: 2022-04-06
Completion date: 2023-04-06
Clinical trial NCT02771860: RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints
Official title: Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Denosumab 60mg sc Every 3 Months in Patients With Erosive Osteoarthritis of the Interphalangeal (IP) Finger Joints
Sponsor: University Hospital, Ghent (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-31
Primary completion date: 2019-06-26
Completion date: 2021-04-28
Plan to share individual participant data: NO
Clinical trial NCT04639310: XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
Official title: A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects With KCNQ2 Developmental and Epileptic Encephalopathy
Acronym: EPIK
Sponsor: Xenon Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision; Not a safety decision
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-29
Primary completion date: 2023-05-16
Completion date: 2023-05-16
Clinical trial NCT04656301: Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Official title: Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-26
Primary completion date: 2022-11-02
Completion date: 2022-11-02
Plan to share individual participant data: NO
Clinical trial NCT03883945: A Safety and Efficacy Study to Evaluate Rosacea
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Intradermally Administered AIV001 in Subjects With Papulopustular Rosacea
Sponsor: AiViva BioPharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor deprioritization
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2021-07-31
Primary completion date: 2022-07-31
Completion date: 2022-08-31
Plan to share individual participant data: NO
Clinical trial NCT03320174: Long-Term Safety Study of Tafenoquine
Official title: Single Site, Randomized, Double Blind, Placebo-Controlled Study to Assess the Long-Term Safety of Tafenoquine
Sponsor: 60 Degrees Pharmaceuticals LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 600.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-05
Primary completion date: 2021-07-13
Completion date: 2021-07-13
Clinical trial NCT03344419: Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Official title: Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Funding
Enrollment: 150.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2017-10-01
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Clinical trial NCT04485663: A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Subcutaneously Administered ALG-010133 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses (Part 1) and Multiple Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
Sponsor: Aligos Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of antiviral activity at the projected efficacious dose.
Enrollment: 103.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-17
Primary completion date: 2022-03-08
Completion date: 2022-03-08
Clinical trial NCT05433402: Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer
Official title: Repurposing the Antipsychotic Drug Chlorpromazine as Adjuvant Therapeutic Agent for Resected Stage III Colon Cancer: A Pilot, Randomized, Open Label, Controlled Study.
Sponsor: Sadat City University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Organizational safety isues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-20
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: YES
Clinical trial NCT03435458: Balloon to Induce Labor in Generous Women.
Official title: Balloon to Induce Labor in Generous Women
Acronym: BIGW
Sponsor: University Hospital, Toulouse (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: interim analyses
Enrollment: 429.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-26
Primary completion date: 2023-02-02
Completion date: 2023-02-02
Clinical trial NCT04233697: Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma
Official title: Phase 1B Study of the PI3K Inhibitor Copanlisib in Combination With Romidepsin in the Treatment of Patients With Relapsed or Refractory Mature T-cell Lymphoma
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Investigator left institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-29
Primary completion date: 2022-07-30
Completion date: 2023-07-30
Plan to share individual participant data: NO
Clinical trial NCT05036317: Empagliflozin for the Treatment of Postprandial Hypoglycemia
Official title: Empagliflozin for the Treatment of Postprandial Hypoglycemia
Acronym: EmpHy
Sponsor: University Hospital, Basel, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Early terminated after prespecified interim analysis due to lack of efficacy. No relevant safety signals.
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-11
Primary completion date: 2024-08-05
Completion date: 2024-08-05
Clinical trial NCT01746225: Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
Official title: A Randomized Phase II Study Evaluating Different Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP Trial)
Acronym: SNAP
Sponsor: ETOP IBCSG Partners Foundation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 258.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-04-30
Primary completion date: 2016-05-31
Completion date: 2023-03-16
Baseline population: Intention-to-treat population. Arm A had randomized 86 patient, but only 83 were analyzed. 3 patients excluded from analysis, who immediately withdrew consent or cancelled treatment.
Clinical trial NCT02732015: Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy
Official title: Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated per PI's request
Enrollment: 37.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-12
Primary completion date: 2020-07-10
Completion date: 2020-07-10
Clinical trial NCT02885727: Durvalumab Plus Booster RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy (GCC 1598)
Official title: Phase II Trial of in Situ Tumor Vaccination Using Durvalumab and Booster Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy
Acronym: Panc-Durval+RT
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Funding issues caused the study to not be opened the at local IRB
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-31
Primary completion date: 2020-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03891979: Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma
Official title: A Pilot Study of Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Suspended due to Primary Investigator's decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-25
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD access criteria: Upon reasonable request. Requests should be directed to Kirsten.Swingle@nyulangone.org. To gain access, data requestors will need to sign a data access agreement
Clinical trial NCT03993288: Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.
Official title: Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Vifor S.A., Switzerland), in Treatment of Patients With Mild and Moderate Iron-deficiency Anaemia.
Sponsor: Sandoz (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 267.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-27
Primary completion date: 2020-06-18
Completion date: 2020-06-18
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent 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.
IPD access criteria: This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04978337: A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression
Acronym: PRIMROSE
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Janssen made the strategic decision to discontinue the PRIMROSE study. This decision is not based on any safety concerns.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-17
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Limitations and caveats: As the study was terminated early, a low number of participants were enrolled, hence some efficacy analyses were not performed per change in the planned analysis. Thereby, data were analyzed for safety and selected efficacy parameters only.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu