A Safety Evaluation of Prismocitrate 18 in Patients Receiving Continuous Renal Replacement Therapy (CRRT) (BXU558476)

Date Added
March 10th, 2026
PRO Number
Pro00148140
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

The purpose of this research study is to confirm the safety of the study drug (Prismocitrate 18) and the study device for patients with acute kidney injury receiving a type of dialysis treatment known as Continuous Renal replacement Therapy (CRRT). When a patient receives CRRT, a blood thinner (also known as an "anticoagulant") is frequently given. In the United States (U.S.), an anticoagulant called, Heparin, is commonly used for CRRT. Some patients have a high risk of bleeding and cannot be given heparin, because it can cause harm to them. For these patients, an anticoagulant, called citrate, can be used. The study drug being tested contains citrate. The study drug works as an anticoagulant and may also help cleanse your blood during the CRRT treatment.

Institution
MUSC
Recruitment Contact
Kayla Adler
(843) 792-0965
recruitment@musc.edu

Predicting Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care

Date Added
March 6th, 2026
PRO Number
Pro00148457
Researcher
Andrew Schreiner

List of Studies


Keywords
Healthy Volunteer Studies, Hepatology, Metabolism, Non-interventional
Summary

To improve the diagnosis of metabolic dysfunction-steatotic liver disease (MASLD) in primary care, this study will develop, test, and internally validate a predictive model for MASLD in a cross-sectional sample of patients with no known chronic liver disease. Patient metabolic variables, like weight, blood pressure, and blood sugar will be considered for inclusion in the model, and ultrasound-based vibration-controlled elastography will be used for determining the outcome. This work will dramatically enhance MASLD diagnosis and management in primary care.

Institution
MUSC
Recruitment Contact
Chloe Cooper
843-876-0448
coopechl@musc.edu

A Phase 2, multinational, multicenter, randomized,double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's disease.

Date Added
March 5th, 2026
PRO Number
Pro00149007
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System
Summary

The study aims to evaluate if an experimental drug called SAR441566 can improve signs and symptoms of moderate to severe Crohn's disease (CD). SAR441566 is a new drug that inhibits Tumor necrosis factor receptor 1 (TNFR1) signaling. This study will also help the Sponsor to understand which dose of SAR441566 is most effective and safe in participants with moderate to severe CD. To do this, 3 different doses of SAR441566 will be tested along with a placebo. The study will last about 1 year, will include about 260 adult participants across over 26 countries.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437921221
recruitment@musc.edu

A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis

Date Added
March 5th, 2026
PRO Number
Pro00148216
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for participants that have been diagnosed with Intermediate or High-risk Primary or Secondary Myelofibrosis. This study is testing an investigational drug called Nuvisertib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the efficacy and safety of Nuvisertib. Nuvisertib is an oral PIM1 selective inhibitor. A PIM1 selective inhibitor is a drug that specifically targets and blocks the activity of the PIM-1 kinase, an enzyme implicated in cancer cell growth. This drug is given to participants by mouth. Participants in this study can expect to be in the treatment phase of this study for 19 months and the long term follow up phase for 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH ATOPIC DERMATITIS PREVIOUSLY TREATED WITH APG777

Date Added
March 4th, 2026
PRO Number
Pro00149283
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study will evaluate the long-term safety and effectiveness of APG777 in patients with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a previous APG777 study. The study is multicenter and double-blind, and participants will continue with the same dose and injection schedule as in their prior study. The study includes three periods: a screening visit, an extended treatment period of about 92 weeks, and a post-treatment follow-up of up to 52 weeks. Patients who met certain improvement criteria in the previous study will continue their maintenance regimen, while others will enter an open-label Escape Arm with a different dosing schedule. The study aims to determine whether long-term use of APG777 is safe and effective for patients who may benefit from continued treatment.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu

Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal Study

Date Added
March 4th, 2026
PRO Number
Pro00148886
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end stage renal disease (ESRD) and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris

Date Added
March 3rd, 2026
PRO Number
Pro00149812
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

The purpose of this clinical research study is to learn more about the use of an investigational medicine, called brepocitinib, for the treatment of Lichen Planopilaris (LPP). The study will also look at how safe and effective brepocitinib is and will monitor the long-term safety of brepocitinib when taken for a period up to 52 weeks.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

At-home transcutaneous auricular neuromodulation (tAN) for women with postpartum depression: an open label trial

Date Added
March 3rd, 2026
PRO Number
Pro00149664
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Anxiety, Depression, Women's Health
Summary

This is an open-label pilot study firstly assessing safety and feasibility of a form of ear stimulation called transcutaneous auricular neuromodulation, or tAN, in women with postpartum depression (PPD). Secondly, we will be assessing the impact of at-home tAN on mood, empathy, and physiological markers of sympathetic activity in women with PPD. Participants will learn how to self-administer ear stimulation treatments in the lab before starting the at-home study. Over the course of one week, participants will self-administer ear stimulation treatments three times a day. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study, as well as undergo heart rate variability (HRV) assessments and provide salivary samples. There will also be a smaller number of questionnaires completed electronically at the midpoint of the study. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and feelings towards their newborn.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

Adapting Written Exposure Therapy for Adolescents with Posttraumatic Stress Disorder

Date Added
March 3rd, 2026
PRO Number
Pro00149514
Researcher
Emily Tilstra-Ferrell

List of Studies

Keywords
Adolescents, Mental Health
Summary

Written Exposure Therapy (WET) is a five-session mental health therapy for post-traumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and formally tested in individual therapy with people aged 12 to 18. Our study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, first we will talk with PTSD experts and people aged 12 to 18 to learn what changes might make WET more suitable for young people. We'll also deliver WET to five people aged 12 to 18 following the manual as it is written for people over age 18 to see what needs adjusting.

In the next part of the study, we will recruit 48 adolescents aged 12 to 18 in a pediatric primary clinic who have symptoms of PTSD and randomize them to either receive the adapted version of WET or to receive gold-standard PTSD treatment: Trauma-Focused Cognitive Behavior Therapy. If assigned to receive adapted WET, participants will take part in five to seven weekly therapy sessions and five study visits (before therapy, and 6-week, 10-week, 20-weeks, and 30 weeks after starting the therapy). If assigned to receive TF-CBT, participants will take part in 12 to 16 weekly therapy sessions and five study visits (before therapy, and 6-week, 10-week, 20-weeks, and 30-weeks after starting the therapy). The purpose of the study visits for a 30-week time period is to better understand who they are as a person and their current mental health symptoms and diagnoses. All therapy and study visits can be completed remotely or in person, per your preference. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Our goal is to find the best way to provide effective PTSD treatment for young people that can be delivered in real-world pediatric primary care settings, so that ultimately more people can get the help they need after traumatic experiences.

Institution
MUSC
Recruitment Contact
Owen Winters
843-792-2615
winterso@musc.edu

Randomized study of larsucosterol in Alcohol-associated Hepatitis to confirm safety and efficacy of Treatment

Date Added
March 3rd, 2026
PRO Number
Pro00148994
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This study will test the hypothesis that treatment with larsucosterol is superior to treatment with placebo for improving the 90-day survival rate and 90-day transplant-free surival rate in participants with severe alcoholic hepatitis (AH).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu



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