Xian, Shaanxi Province, China
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A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial
This study is a multi-center, randomized, double blind, placebo-controlled dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be used as SC in this study. The study will have three (3) phases: Screening (2 weeks), Treatment Phase (13 weeks, with treatment up to 12 weeks) and Follow-Up (12 weeks). Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease) in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either the Active Treatment (VF001-DP low or high dose plus SC) or the Control Treatment (Placebo plus SC) in a ratio of 1:1:1. For more information see: [https://clinicaltrials.gov/ct2/show/NCT02973893?term=vf00102&rank=1](https://clinicaltrials.gov/ct2/show/NCT02973893?term=vf00102&rank=1) Contact: Anthony Bishop, [a.bishop@factor- therapeutics.com](mailto:a.bishop@factor-therapeutics.com) for further information.
Phase
2Span
Sponsor
Factor TherapeuticsWyomissing, Pennsylvania
Recruiting
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Phase
3Span
238 weeksSponsor
Boehringer IngelheimWyomissing, Pennsylvania
Recruiting
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Phase
3Span
376 weeksSponsor
Boehringer IngelheimWyomissing, Pennsylvania
Recruiting
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 1 (ALKS 2680-201)
Phase
2Span
70 weeksSponsor
Alkermes, Inc.Wyomissing, Pennsylvania
Recruiting
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer. Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT. The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan. All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.
Phase
N/ASpan
185 weeksSponsor
Freenome Holdings Inc.Wyomissing, Pennsylvania
Recruiting
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.
Phase
2Span
379 weeksSponsor
Eli Lilly and CompanyWyomissing, Pennsylvania
Recruiting
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints. Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.
Phase
3Span
204 weeksSponsor
DalCor PharmaceuticalsWyomissing, Pennsylvania
Recruiting
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
REACT-AF is a prospective, unblinded, randomized (1:1 allocation), multi-center, investigational clinical trial of men and women aged 22-85 with a documented history of symptomatic or asymptomatic paroxysmal or persistent (AF) and a moderate risk of stroke measured by CHA2DS2-VASc score 1-4 for men, 2-4 for women (which stands for Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, age 65 to 74 and sex category (female)). Participants randomized to the experimental arm (on demand DOAC) will take the participants DOAC for 30 consecutive days following a qualifying AF episode (i.e., greater than1 hour) detected by the AFSW. Participants randomized to the standard of care (control) arm will remain on previously prescribed continuous DOAC throughout the study. A total of 5350 participants will be enrolled across up to 100 study sites targeting two-thirds academic and one-third private practices, with academic practices also enrolling from affiliated community sites. The investigators anticipate evaluating 7643 consented individuals with external monitoring to ensure that a low AF burden population will be randomized. Up to 200 participants may be enrolled at any one site, and participation will last up to 60 months.
Phase
3Span
316 weeksSponsor
Johns Hopkins UniversityWyomissing, Pennsylvania
Recruiting
A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
Phase
3Span
217 weeksSponsor
Novo Nordisk A/SWyomissing, Pennsylvania
Recruiting
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Phase
3Span
91 weeksSponsor
UCB Biopharma SRLWyomissing, Pennsylvania
Recruiting