A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance with Cell-free DNA versus Endomyocardial Biopsy (ACES-EMB)

Date Added
February 25th, 2025
PRO Number
Pro00141118
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Heart, Transplant
Summary

This study is an open label, Comparative Effectiveness Research study in patients who receive a heart transplant. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. The study objective is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.
The Prospera™ test is a non-invasive test intended to detect and quantify the fraction of donor-derived cell-free DNA (dd-cfDNA) to supplement management and surveillance of allograft rejection in patients who have undergone organ transplantation. The subjects may undergo blood draws, echocardiogrphys, medical history and physical exams, antibody testing, nuclear imaging, and MRI as apart of the study. The study period will be during the first 12 months post-transplant. Quality of life questionnaires will be completed at week 4, month 6 and month 12 post-transplant.

Institution
MUSC
Recruitment Contact
Madison Johnson
8437924615
johme@musc.edu

Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients with COPD.

Date Added
February 25th, 2025
PRO Number
Pro00140657
Researcher
Sarah Miller

List of Studies


Keywords
Breathing, COPD
Summary

The goal of this study to test whether a 12-week home-based program delivered over the internet to people who have COPD and live in rural parts of the country can improve their health and overall quality of life. In this study, we will enroll 306 volunteers with COPD. The study is sponsored by a grant receive from the NIH National Institute of Nursing Research.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-792-3512
pittmama@musc.edu

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Date Added
February 25th, 2025
PRO Number
Pro00140492
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.

Institution
MUSC
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Date Added
February 21st, 2025
PRO Number
Pro00141448
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have recurrent/persistent endometrial cancer. The investigational drug used in this study is Sacituzumab Govitecan (SG). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The study drug is given to participants through infusion. The primary purpose of the study is to compare the effect of SG relative to treatment of physician's choice (TPC) on progression-free survival (PFS) and on overall survival (OS). Participants can expect to be on this study until their demise.

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

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Date Added
February 14th, 2025
PRO Number
Pro00141956
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.

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

An open-label, single-arm study to evaluate the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents aged ≥12 to ≤17 years at the time of study inclusion with active moderate to severe hidradenitis suppurativa.

Date Added
February 13th, 2025
PRO Number
Pro00141590
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

M1095-HS-304 is a Phase 3, open-label, single-arm design that assesses the safety and tolerability of sonelokimab in adolescent patients with HS. The study population will comprise adolescent participants (aged ≥12 to ≤17 years) with moderate to severe HS.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
8438760110
yeadon@musc.edu

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 12th, 2025
PRO Number
Pro00142401
Researcher
Lauren Sullivan

List of Studies

Keywords
Nontuberculous mycobacteria (NTM)
Summary

This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu



-- OR --