chufangao/CTO huggingface dataset:
Clinical trial NCT05328102: Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)
Official title: A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb13676 (Plamotamab) Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Xencor, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study has been terminated early by the sponsor due to business decision.
Enrollment: 3.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-15
Primary completion date: 2023-02-21
Completion date: 2023-02-21
Baseline population: Enrolled Analysis Set: All participants who signed the informed consent form, were determined to be eligible, and received Day -8 tafasitamab dose (Study Day 1). The study was terminated by the Sponsor during Part 1A of the study. No participants were enrolled in Part 1B or Part 2.
Limitations and caveats: Due to the early termination of the study in Part 1A, only 3 participants enrolled. No participants were enrolled in Part 1B or Part 2. Safety data is limited due to the small sample size. No efficacy data was collected for the secondary outcome measures.
Clinical trial NCT04929249: A Randomized Study to Evaluate the Effect of an Inclisiran First Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
Official title: A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an Inclisiran First Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
Acronym: V-INITIATE
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 450.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-25
Primary completion date: 2023-09-15
Completion date: 2023-09-15
Plan to share individual participant data: YES
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 NCT04945733: A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer
Official title: A Phase 2, Open-label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer
Sponsor: Janssen Pharmaceutical K.K. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to reconsideration of development strategy
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-30
Primary completion date: 2023-07-03
Completion date: 2023-07-03
Limitations and caveats: The study was planned to be conducted in 2 cohorts: Phase 2a cohorts (including Phase 2a extension cohort) and Phase 2b expansion cohort. However, due to study termination, no participants were enrolled in Phase 2a extension and Phase 2b cohorts. Hence results were only presented for Phase 2a cohorts. Phase 2b specific outcome measure (overall survival) were not included in the results.
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
Clinical trial NCT04659044: Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Official title: A Phase 2 Trial of the Combination of Polatuzumab Vedotin, Venetoclax and Rituximab and Hyaluronidase Human for Relapsed and Refractory Mantle Cell Lymphoma
Sponsor: Academic and Community Cancer Research United (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial closed due to low accrual rate
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-01
Primary completion date: 2024-03-28
Completion date: 2024-03-29
Clinical trial NCT02110069: A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors
Official title: A Randomized Phase 2 Study of Vincristine Versus Sirolimus to Treat High Risk Kaposiform Hemangioendothelioma (KHE).
Sponsor: Boston Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study was challenged by the incidence of KHE with KMP as this continued to be extremely rare, and very sporadic. In July of 2019 grant renewal funding ended.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-14
Primary completion date: 2019-10-02
Completion date: 2020-10-27
Baseline population: no analysis was performed as study was closed early
Plan to share individual participant data: NO
Clinical trial NCT03290781: An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
Acronym: FIGARO UC 303
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 366.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-04
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Baseline population: The safety set consisted of all participants who had received at least 1 dose of Investigational Product (IP) in this study, regardless of treatment received during the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
Clinical trial NCT03173560: Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Official title: A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 343.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-17
Primary completion date: 2020-02-14
Completion date: 2024-06-30
Baseline population: Full analysis set (FAS) included all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT02965911: Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
Official title: A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA
Sponsor: Beijing 302 Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2021-09-08
Completion date: 2021-09-08
Plan to share individual participant data: NO
Clinical trial NCT05446129: A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery
Official title: A Phase I Open Label Study to Assess Safety, Feasibility, Efficacy, and Biological Activity of Single Administration of Neoadjuvant Treatments Ezabenlimab in Combination With BI 765063 and Pembrolizumab in Combination With BI 765063 in Patients With Newly Diagnosed Surgically-resectable, Locoregional Colorectal Cancer
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-27
Primary completion date: 2023-08-11
Completion date: 2023-11-08
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency
Clinical trial NCT03435081: A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Acronym: BREEZE-AD5
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 440.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-02-20
Primary completion date: 2019-12-09
Completion date: 2021-08-16
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03904849: Cannabidiol for Alcohol Use Disorder
Official title: A Pilot Human Laboratory Study of Cannabidiol in Alcohol Use Disorder
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: This study was intended to produce pilot data for a center grant component that will no longer be conducted.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Plan to share individual participant data: NO
Clinical trial NCT03742323: REALIB-LLA-2017: Idelalisib in Patients With Acute Lymphoblastic Leukemia
Official title: Phase I-II Unmasked, Non-randomized Study Evaluating the Role of Idelalisib in Patients With Acute Lymphoblastic Leukemia (ALL) That is Relapsing or Refractory to Other Treatments, and in Older Patients With ALL for Whom Conventional Treatments Are Not Recommended
Sponsor: PETHEMA Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Because of low recruitment
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-01
Primary completion date: 2020-06-02
Completion date: 2020-06-02
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02603146: Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
Official title: Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
Acronym: StopRA
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment was closed before reaching the target. In the 1st interim analysis after enrollment closure, the follow up \& treatment of active participants were stopped early due to evidence of futility.
Enrollment: 144.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-27
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Baseline population: The intent-to-treat population includes all randomized participants.
Limitations and caveats: Enrollment closed at 144 randomized participants before reaching the target of 200 due to slow participant accrual. The decision was supported by a revised power analysis suggesting sufficient power for the study with reduced numbers assuming a clinically-relevant difference in RA rates between arms (50% risk for placebo \& 25% risk for HCQ). In the 1st interim analysis after enrollment closure, the follow up \& treatment of the active participants were stopped early due to evidence of futility.
Plan to share individual participant data: YES
IPD sharing description: The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts, upon completion of the trial.
IPD time frame: After completion of the study.
IPD access criteria: When posted, the IPD will be available to the public.
Clinical trial NCT03712358: PVSRIPO for Patients With Unresectable Melanoma
Official title: A Phase I Trial of PVSRIPO for Patients With Unresectable Melanoma
Sponsor: Istari Oncology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study closed to enrollment due to business decision prior to enrolling Cohort 4
Enrollment: 12.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-11-26
Primary completion date: 2021-03-23
Completion date: 2021-03-23
Baseline population: Study closed to enrollment due to business decision prior to enrolling Cohort 4.
Clinical trial NCT04558125: Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
Official title: Low-Dose Tenecteplase in Covid-19 Patients With Acute Pulmonary Embolism: A Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Identification of eligible patients was slower than anticipated.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-08
Primary completion date: 2021-07-10
Completion date: 2021-08-08
Baseline population: The study was terminated early and never unblinded. With only 2 subjects, statistical significance could never be demonstrated. Therefore, Arm/Group randomization information is not available.
Limitations and caveats: The study was terminated early due to enrollment being slower than anticipated, with study enrollment highly dependent upon COVID-19 surge patterns. We were otherwise hopeful to enroll and complete all assessments for this study.
Plan to share individual participant data: NO
Clinical trial NCT04524949: IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study)
Official title: A Phase IIa, Randomized, Double-blind, Dose Comparison, Placebo-controlled, Multi-centre Clinical Trial to Evaluate the Immune Signature of the Treatment With the Imotope IMCY-0098 and Its Effect on the Preservation of Beta-cell Function in Adult Patients With a Recent Onset Type 1 Diabetes
Acronym: IMPACT
Sponsor: Imcyse SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No efficacy at primary analysis after 1 year. Long term follow-up stopped
Enrollment: 110.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-29
Primary completion date: 2024-01-26
Completion date: 2024-05-29
Plan to share individual participant data: NO
Clinical trial NCT04106557: A Study of OV101 in Individuals With Angelman Syndrome (AS)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome
Acronym: NEPTUNE
Sponsor: Ovid Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-09
Primary completion date: 2020-11-02
Completion date: 2020-11-02
Clinical trial NCT01950182: Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer
Official title: A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype
Acronym: SYSUCC-002
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 392.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-09-16
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Plan to share individual participant data: NO
Clinical trial NCT04639245: Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer
Official title: ATTAMAGE-A1.: Phase I/II Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity MAGE-A1-Specific T-Cell Receptor (TCR) Combined With Atezolizumab in Patients With Metastatic MAGE-A1 Expressing Cancer
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow accrual.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-19
Primary completion date: 2022-08-04
Completion date: 2022-08-16
Plan to share individual participant data: NO
Clinical trial NCT02613507: Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
Official title: An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078)
Acronym: CheckMate 078
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 639.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-11
Primary completion date: 2017-09-15
Completion date: 2023-11-24
Clinical trial NCT02864394: Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
Official title: A Multinational, Multicenter, Phase III, Randomized Open-label Trial of Pembrolizumab Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 425.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-07
Primary completion date: 2019-09-09
Completion date: 2022-10-14
Limitations and caveats: Protocol amendment 5 called for participant discontinuation from this study under protocol-specified circumstances.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05135000: Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension
Official title: A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2024-03-20
Completion date: 2024-04-25
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.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04272242: Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals
Official title: Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Opening of Arm 2 was dependent upon assessment of DTG pharmacokinetics (PK) data from participants in Arm 1. Arm 1 is complete and results are reported. Arm 2 was not conducted based on the Arm 1 PK assessment.
Enrollment: 37.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-27
Primary completion date: 2021-12-15
Completion date: 2021-12-27
Baseline population: All participants who enrolled to the study
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification.
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD access criteria: * With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
Clinical trial NCT03414983: An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread
Official title: An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer
Acronym: CheckMate 9X8
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 196.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-20
Primary completion date: 2021-02-01
Completion date: 2022-12-28
Clinical trial NCT02212015: Evaluation of Votrient in Angiosarcoma
Official title: Single-arm, Multicenter, Open Label Phase II Trial to Evaluate the Efficacy of Pazopanib in Combination With Paclitaxel in Advanced and Relapsed Angiosarcoma
Acronym: EVA
Sponsor: Heidelberg University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to interim analysis' results and definitions fixed in protocol
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-07-31
Primary completion date: 2019-12-31
Completion date: 2020-07-01