chufangao/CTO huggingface dataset:
Clinical trial NCT04398134: A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Official title: A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
Sponsor: Assembly Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study stopped due to a safety signal of drug-induced liver injury in subjects receiving 2158
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-28
Primary completion date: 2021-10-14
Completion date: 2021-12-28
Limitations and caveats: Study ABI-H2158-201 was terminated early due to alanine aminotransferase (ALT) elevations among study participants who received ABI-H2158 (and not among those who received PBO). Further details on these events are described in the results section below. In the absence of an alternative etiology for the ALT elevations, further clinical development of ABI-H2158 was terminated by the Sponsor.
Plan to share individual participant data: NO
Clinical trial NCT04913675: Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
Official title: A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831
Sponsor: Vir Biotechnology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes
Enrollment: 1065.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-06-10
Primary completion date: 2022-07-19
Completion date: 2023-03-24
Baseline population: Baseline characteristics were reported for Safety Population for Main Study and Safety Sub-study.
Limitations and caveats: The pre-specified daily imputation resulted in overly high inflation in the estimated progression rates for missing data. To reduce this bias and to account for progression history, weekly imputation was used for final conclusions.
Clinical trial NCT03381833: A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia
Official title: A Multi-Center, Randomized, Open-Label, Parallel-Group Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia
Sponsor: La Jolla Pharmaceutical Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated early for lack of efficacy as determined by interim endpoint analyses
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-30
Primary completion date: 2019-12-03
Completion date: 2020-01-14
Plan to share individual participant data: NO
Clinical trial NCT05993143: Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50
Official title: A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age
Sponsor: Insud Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.
Enrollment: 249.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-18
Primary completion date: 2021-07-21
Completion date: 2021-07-21
Plan to share individual participant data: NO
Clinical trial NCT04487431: A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)
Official title: Single-center, Open-label, Non-placebo-controlled, Single-dose Study in Healthy Male Participants to Determine the Pharmacokinetics of BAY 1817080 Oral Solution (Part A) and to Investigate the Pharmacokinetics, Metabolic Disposition and Mass Balance of [14C]BAY 1817080 Oral Solution (Part B)
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-05
Primary completion date: 2020-09-30
Completion date: 2021-02-11
Plan to share individual participant data: NO
IPD sharing description: There are no current plans to share data. 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 NCT04115059: Dasatinib In Waldenström Macroglobulinemia
Official title: Dasatinib in Patients With Waldenström Macroglobulinemia (WM) Progressing on Ibrutinib
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-04
Primary completion date: 2021-12-31
Completion date: 2021-12-31
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: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT03852576: Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Official title: Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study had to be terminated for lack of dimer and inability to produce more at this time.
Enrollment: 38.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-09
Primary completion date: 2020-11-18
Completion date: 2020-11-18
Plan to share individual participant data: YES
Clinical trial NCT04601285: A Phase I Study of JS108 in Patients With Advanced Solid Tumors
Official title: A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
Sponsor: Shanghai Junshi Bioscience Co., Ltd. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor has adjusted study development plan and terminated this clinical study.
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-28
Primary completion date: 2023-06-14
Completion date: 2023-06-14
Clinical trial NCT02949934: Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-05-01
Primary completion date: 2021-04-13
Completion date: 2021-04-13
Baseline population: Non-treatment-seeking individuals between the ages of 21 and 40 with DSM-5 diagnosed Alcohol Use Disorder.
Plan to share individual participant data: NO
Clinical trial NCT04847921: Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition
Official title: Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections
Acronym: SUDDEN-OUT
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-30
Primary completion date: 2023-10-05
Completion date: 2023-10-05
Plan to share individual participant data: NO
Clinical trial NCT03478878: Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
Official title: An Investigation of Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-14
Primary completion date: 2022-06-17
Completion date: 2022-06-17
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03174522: The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
Official title: The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial
Sponsor: Ixaka Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Independent Data Monitoring Committee recommendation to stop due to futility
Enrollment: 49.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-25
Primary completion date: 2023-02-13
Completion date: 2023-02-13
Plan to share individual participant data: NO
Clinical trial NCT03854227: A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study has been terminated based on a strategic evaluation within the current Pfizer oncology portfolio. This decision is not due to any safety concerns or requests from any regulatory authorities.
Enrollment: 54.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-03-14
Primary completion date: 2022-04-27
Completion date: 2022-04-27
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 NCT03770455: Avelumab Plus 2nd-generation ADT in African American Subjects With mCRPC
Official title: PDL-1 Inhibition With Avelumab and Concurrent Second-generation ADT in African Americans With Castrate-resistant Metastatic Prostate Cancer
Sponsor: Tulane University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early signs of progression and learned experience that the assumed time period between psa progression and radiographic progression was shorter than expected
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-25
Primary completion date: 2020-12-17
Completion date: 2021-01-07
Limitations and caveats: Study did not reach target number of participants needed to reach target power for statistically reliable results due to poor recruitment during Coronavirus Disease 2019 (COVID-19) pandemic and early termination of study.~Study closed early due to safety concerns regarding rapid clinical progression of several participants, therefore, the secondary outcome measures were not analyzed and no data was reported for those outcome measures, so they were deleted from the study record.
Plan to share individual participant data: YES
IPD sharing description: all collected IPD, all IPD that underlie results in a publication
IPD time frame: 2022
IPD access criteria: To be determined pending publication
Clinical trial NCT03624036: Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Official title: A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Acronym: ZUMA-8
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Development program terminated
Enrollment: 16.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-11-15
Primary completion date: 2021-02-12
Completion date: 2022-11-18
Baseline population: Safety Analysis Set included all participants who were treated with any dose of brexucabtagene autoleucel.
Plan to share individual participant data: NO
Clinical trial NCT04518410: ACTIV-2: A Study for Outpatients With COVID-19
Official title: Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 4044.0 (ACTUAL)
Number of arms: 25.0
Start date: 2020-08-19
Primary completion date: 2022-04-07
Completion date: 2023-06-20
Baseline population: Total MITT Population=Randomized and Treated and included in analysis = All with Randomization Date - Randomized Not Treated-Randomized screen failed - Excluded from analysis - Dual enrollment = 4044 - 54 - 2 - 252 - 1~All participants were considered to be separately enrolled participants for subsequent phases of the study.~BRII arms included pooled participants from Phase 2/Phase 3 to complete a Phase 3 analysis.
Plan to share individual participant data: YES
IPD sharing description: Individual patient level data are available from ACTIV-2 clinical trial in accessclinicaldata@NIAID, a NIAID cloud-based secure controlled access data platform that enables sharing of and access to data sets from clinical trials for basic and clinical research and requires a data access request and a signed data use agreement.
IPD access criteria: NIAID OCICB requires a Data Use Agreement be signed by investigators seeking to obtain the PUD.
Clinical trial NCT03634150: Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer
Official title: A Phase 1b, Open-Label, Dose-Confirmation Study Evaluating the Safety, and Clinical Effects of Intravenously Administered Nerofe™ in Combination With Doxorubicin, In Subjects With Metastatic Ovarian Cancer and Triple Negative Breast Cancer
Sponsor: Immune System Key Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Patients were screened but not enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-06
Primary completion date: 2020-04-21
Completion date: 2020-04-21
Plan to share individual participant data: NO
Clinical trial NCT03759184: Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
Official title: Phase 1 Trial of Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was closed after \> 1 year of inactivity.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-11
Primary completion date: 2019-12-15
Completion date: 2021-10-22
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genome 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 (BTRIS) and with the permission of the study principal investigator (PI).~Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT02827968: Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors
Official title: A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor: 3D Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-13
Primary completion date: 2020-08-31
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04441398: Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients
Official title: Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita
Sponsor: Azidus Brasil (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor's strategic decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-31
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
IPD sharing description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
Clinical trial NCT04925934: Study of VIB7734 for the Treatment of Moderate to Severely Active SLE
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus
Acronym: RECAST SLE
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 214.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-28
Primary completion date: 2023-05-16
Completion date: 2023-06-09
Baseline population: Full analysis set (FAS): included all randomized participants who received any dose of investigational product (IP). Participants were analyzed according to the treatment randomized.
Plan to share individual participant data: NO
Clinical trial NCT04269395: A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study
Official title: A Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199
Sponsor: Galderma R&D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated early as per Sponsor's decision
Enrollment: 125.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-07
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Baseline population: Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses.
Limitations and caveats: This LTFU study was terminated early by the Sponsor because in the main study RD.06.SPR.112199, the primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT in terms of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.
Clinical trial NCT05730673: Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer
Official title: A Phase II Study of Leronlimab (PRO 140) in Combination With Regorafenib in Patients With CCR5+, Microsatellite Stable (MSS), Metastatic Colorectal Cancer (mCRC)
Sponsor: CytoDyn, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-20
Primary completion date: 2023-05-27
Completion date: 2023-08-10
Clinical trial NCT04964388: Effect of GLP-1 Receptor Agonists on Trabecular Bone Score
Official title: Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.
Sponsor: University of Mississippi Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Not able to recruit participants
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-09
Primary completion date: 2023-05-01
Completion date: 2023-07-01
Plan to share individual participant data: NO
IPD sharing description: No sharing
Clinical trial NCT03969420: Study of Alvocidib in Patients With Relapsed/Refractory AML Following Treatment With Venetoclax Combination Therapy
Official title: A Phase 2, Open-label, Randomized, Two-stage Clinical Study of Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia Following Treatment With Venetoclax Combination Therapy
Sponsor: Sumitomo Pharma America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business decision to terminate the development of alvocidib program on 17 November 2020. Patients permitted on treatment until April 22, 2021. The last end-of-treatment follow-up completed on May 14, 2021.
Enrollment: 11.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-01-15
Primary completion date: 2021-04-22
Completion date: 2021-05-14
Clinical trial NCT03123588: Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
Official title: A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment issues
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-14
Primary completion date: 2020-08-03
Completion date: 2020-08-03
Plan to share individual participant data: NO