chufangao/CTO huggingface dataset:
Clinical trial NCT02228369: Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer
Official title: A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumour Activity of AZD3759 or AZD9291 in Patients With EGFR Mutation Positive Advanced Stage Non Small Cell Lung Cancer (NSCLC)
Acronym: BLOOM
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-11-05
Primary completion date: 2017-08-19
Completion date: 2020-10-28
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03928275: The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma
Official title: The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma
Sponsor: Nova Scotia Health Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Withdrawn prematurely.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Plan to share individual participant data: NO
Clinical trial NCT03263715: A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)
Sponsor: Medical University of Vienna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-24
Primary completion date: 2020-06-02
Completion date: 2020-06-02
Clinical trial NCT05464420: A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Official title: A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2162.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-08-12
Primary completion date: 2023-05-25
Completion date: 2023-05-25
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04283136: A Study to Test the Blood Concentration of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
Official title: An Open-Label, Randomized, Single-Dose, 2-Part Crossover Study in Healthy Study Participants to Evaluate the Relative Bioavailability of 4 Padsevonil Product Variants and the Effect of Food on Padsevonil
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrollment: 0.0 (ACTUAL)
Number of arms: 9.0
Start date: 2020-02-24
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT04908956: Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)
Official title: A Multicentre Single-arm Phase II Trial Assessing the Safety and Efficacy of First-line Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
Acronym: STEREO
Sponsor: ETOP IBCSG Partners Foundation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The trial struggled with low activation due to the COVID pandemic. The Steering Committee took the decision to close the accrual in the STEREO trial as of 31 October 2023. It is important to note that no safety concerns have led to this decision.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-04
Primary completion date: 2023-10-31
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT04800562: A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
Sponsor: Processa Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: lack of enrollment of this ultra rare disease
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-12
Primary completion date: 2023-02-28
Completion date: 2023-04-14
Plan to share individual participant data: NO
Clinical trial NCT03121989: Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Acronym: LABC
Sponsor: Sunnybrook Health Sciences Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funding completed
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-21
Primary completion date: 2023-03-23
Completion date: 2023-03-23
Plan to share individual participant data: NO
Clinical trial NCT03781726: Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Official title: A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus
Acronym: MYTHIC
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-10
Primary completion date: 2020-03-20
Completion date: 2021-12-31
Plan to share individual participant data: YES
IPD sharing description: Coded data is anticipated to be shared with collaborators in this multi-center consortium
IPD time frame: Real time
IPD access criteria: researchers accessing IPD must be an approved site within the consortium.
Clinical trial NCT04727736: 18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
Official title: Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Intervention became FDA-approved
Enrollment: 47.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Baseline population: Patients that received study intervention and were radiologically evaluable.
Plan to share individual participant data: NO
Clinical trial NCT02609386: IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
Official title: A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
Acronym: INSPIRE
Sponsor: Brooklyn ImmunoTherapeutics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 105.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-11
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Limitations and caveats: One of the initial secondary objectives of the study was to compare the feasibility of each booster regimen (Regimen 1 vs Regimen 2) post-surgery. However, as a significant number of patients were unable to receive booster treatments due to tolerability issues and/or their post-surgery/post-adjuvant chemoradiation therapy status, booster regimens were discontinued and analysis of booster feasibility was not performed due to insufficient data for a meaningful, statistically sound analysis.
Clinical trial NCT04906980: A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety and Tolerability, and Pharmacokinetics of JNJ-64281802 in Participants With Confirmed Dengue Fever
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Feasibility of enrollment impacted by COVID
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-24
Primary completion date: 2022-09-24
Completion date: 2023-03-21
Limitations and caveats: Since feasibility of enrollment was impacted by COVID, sponsor terminated the study. Due to small number of enrolled participants, planned data collection and analysis was not performed for the efficacy objectives and thus no data was reported for efficacy outcome measures.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
Clinical trial NCT04472494: Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Official title: Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-14
Primary completion date: 2021-08-12
Completion date: 2021-09-13
Clinical trial NCT02930122: IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions
Official title: A Prospective, Single-Center, Randomized, Triple-Blinded, Placebo-Controlled Study of IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions
Acronym: EASI ACL
Sponsor: University of Kentucky (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of funding
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-20
Primary completion date: 2020-10-16
Completion date: 2020-10-16
Baseline population: 6 participants had been enrolled at the time the study was closed (3 participants in each group)
Plan to share individual participant data: NO
Clinical trial NCT03027973: Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding
Official title: Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial
Sponsor: University of Saskatchewan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI made the decision to not continue the study. It was at the Health Canada review stage.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-31
Primary completion date: 2020-01-31
Completion date: 2020-01-17
Plan to share individual participant data: NO
Clinical trial NCT05743777: PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma
Official title: A Phase II Study of PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma
Acronym: PROMOTE-HN
Sponsor: Canadian Cancer Trials Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Company withdrew financial support
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-05-12
Primary completion date: 2023-05-12
Completion date: 2023-05-12
Plan to share individual participant data: NO
Clinical trial NCT05176717: Study to Evaluate the Efficacy Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene With Early to Moderate Vision Loss (Celeste)
Official title: A Double-Masked, Randomized, Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of QR-421a in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene With Early to Moderate Vision Loss
Sponsor: Laboratoires Thea (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-15
Primary completion date: 2022-08-02
Completion date: 2022-08-02
Limitations and caveats: Study prematurely terminated due to sponsor decision for reasons unrelated to safety
Plan to share individual participant data: NO
Clinical trial NCT05221749: The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
Official title: The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial
Sponsor: Alexandria University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Only the 1 month follow-up was completed. The principal investigator could not complete the 3 month follow-up appointments and was not calibrated with other dentists who were available at the time.
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-15
Primary completion date: 2022-04-15
Completion date: 2022-06-15
Baseline population: Children 4-6 years old with at least 1 active dentin caries lesion.
Plan to share individual participant data: NO
IPD sharing description: Each participant will be provided with a serial number that will only be accessible to the principal investigator. No data regarding the identity of the participants will be shared under any circumstances. All participants or their guardians must provide a written informed consent prior to any procedures.
Clinical trial NCT04865029: Estradiol and Progesterone in Hospitalized COVID-19 Patients
Official title: Acute Estradiol and Progesterone Therapy in Hospitalized Adults to Reduce Coronavirus Disease (COVID-19) Severity: A Randomized Control Trial
Sponsor: Tulane University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment due to change of COVID 19 variant prevalence
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-22
Primary completion date: 2022-01-25
Completion date: 2022-01-25
Limitations and caveats: Early termination leading to small numbers of subjects analyzed
Plan to share individual participant data: NO
Clinical trial NCT03365661: QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML
Official title: QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases
Sponsor: Masonic Cancer Center, University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor halted study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-30
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Clinical trial NCT03520712: Gene Therapy Study in Severe Hemophilia a Patients with Antibodies Against AAV5
Official title: A Phase 1/2 Safety, Tolerability, and Efficacy Study of Valoctocogene Roxaparvovec, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia a Patients with Residual FVIII Levels ≤ 1 IU/dL and Pre-existing Antibodies Against AAV5
Acronym: GENEr8-AAV5+
Sponsor: BioMarin Pharmaceutical (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Early rollover into long-term extension study
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-03
Primary completion date: 2024-08-07
Completion date: 2024-08-07
Plan to share individual participant data: NO
Clinical trial NCT03790865: Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
Official title: A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome
Acronym: ZEPHYR
Sponsor: Millendo Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors
Enrollment: 158.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-25
Primary completion date: 2020-02-26
Completion date: 2020-05-25
Limitations and caveats: The double-blind, placebo-controlled phase 2b study did not meet the primary endpoint or any of the secondary endpoints. Therefore, the Sponsor has decided to discontinue further development of livoletide.
Plan to share individual participant data: NO
Clinical trial NCT03933761: Pamiparib in Fusion Positive, Reversion Negative High Grade Serous Ovarian Cancer or Carcinosarcoma With BRCA1/2 Gene Mutations If Progression on Substrate Poly ADP Ribose Polymerase Inhibitbor (PARPI) or Chemotherapy
Official title: A Phase II, Signal-Seeking Trial of the Clinical Benefit Rate Associated With Pamiparib in Subjects With Germline or Somatic BRCA1/2 High Grade Serous Ovarian Cancer or Carcinosarcoma Who Have Progressed on P-gp Substrate Chemotherapy or PARPi With the Presence of an ABCB1 Fusion and the Absence of a BRCA1/2 Reversion
Acronym: PRECISE
Sponsor: Australia New Zealand Gynaecological Oncology Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No eligible patient identified after 18 evaluable patients underwent pre-screening over a 2 year period.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-29
Primary completion date: 2021-08-02
Completion date: 2021-08-02
Plan to share individual participant data: NO
Clinical trial NCT04708418: A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma
Official title: Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination With CMP-001 in Patients With Operable Melanoma: Efficacy and Biomarker Study
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Drug Supply Issues
Enrollment: 60.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-10-15
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT02273362: Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver
Official title: Pilot Study of EGFR Inhibition With Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-11-24
Primary completion date: 2020-02-11
Completion date: 2022-03-10
Baseline population: All patients registered and treated per protocol are included in this analysis.
Clinical trial NCT03374488: Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
Official title: A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-22
Primary completion date: 2018-07-27
Completion date: 2020-07-23
Baseline population: The Intention-to-Treat (ITT) population consisted of all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT03594175: Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
Official title: A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
Acronym: READY1
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to ongoing recruitment challenges globally, it is not possible to complete this study. The decision is not based on any reported changes in the safety profile or any concerns with the anticipated efficacy profile of the investigational product.
Enrollment: 462.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-12
Primary completion date: 2023-06-08
Completion date: 2023-07-10
Baseline population: Baseline was defined as the last non-missing value available before the first study drug administration.
Limitations and caveats: 13 June 2023, Chiesi issued an initial notification of enrolment hold to all participating study sites for READY 1 study.~05 July 2023, Chiesi issued a voluntary official notification of early termination of study recruitment to all participating sites, due to non-safety reasons. Patient recruitment was slow and completion of the study was not feasible in a reasonable timeframe. Early termination of the study was not expected to impact patient access to other necessary treatments.
Plan to share individual participant data: NO
Clinical trial NCT02882126: An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension
Official title: An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003
Sponsor: United Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-30
Primary completion date: 2021-06-30
Completion date: 2021-06-30