A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults with Selected Advanced Solid Tumors

Date Added
December 6th, 2024
PRO Number
Pro00138422
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 in adult participants with locally advanced or metastatic selected solid tumors.

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

M22-574: Phase 3 ABBV-383 vs Standard Available Treatment in Subjects with RRMM with at Least 2 Prior Lines of Therapies

Date Added
December 6th, 2024
PRO Number
Pro00136949
Researcher
Kimberly Green

List of Studies

Keywords
Cancer
Summary

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

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

A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Date Added
December 10th, 2024
PRO Number
Pro00138267
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well Petosemtamab works at curing this type of cancer. The study results may be used to help others in the future.

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Oral Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 349 in PiZZ and PiMZ/MASH Adult Participants

Date Added
December 10th, 2024
PRO Number
Pro00141286
Researcher
Charlie Strange

List of Studies


Keywords
Drug Studies, Genetics, Liver, Rare Diseases
Summary

Alpha-1 antitrypsin (AAT) deficiency is a condition in which the body does not make enough of AAT, a protein that protects the lungs and liver from damage. This condition is inherited, meaning you get the faulty gene from one or both of your parents.

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral administration of BMN 349 in adult participants with the PiZZ genotype (also defined as having a severe deficiency or AAT ≤ 60mg/dL) or PiMZ genotype with metabolic dysfunction-associated steatohepatitis (MASH). Participants will receive an oral single dose of BMN 349 (250 mg), a medication designed to assist Z-alpha-1 antitrypsin to get out of the liver cell. The study drug BMN 349 has not been approved by the Federal Drug Administration (FDA).

This is a phase 1 study in which participants will get a single pill dose of drug or placebo to measure the amount of alpha-1 that gets out of the liver cells and into the bloodstream. Study details include:
• Study duration: up to 78 days
• Treatment duration: 1 day (single dose).
• Observations: The study will collect data on medical history, physical examination, vital signs, electrocardiogram readings, clinical laboratory parameters, pulmonary function tests, and drug distribution.
• Visit frequency: The Screening Visit, dosing, and post dosing evaluations will be conducted at MUSC on 3 consecutive days. Visits at days 8 and 36 days will occur at study site. Other procedures/assessments may be performed at the study site or at home by a healthcare professional and/or by telemedicine.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System vs. Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study).

Date Added
December 10th, 2024
PRO Number
Pro00141175
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study involves a procedure called renal denervation with an investigational device called the TIVUS™ system for the treatment of resistant hypertension (high blood pressure). Investigational means it is not yet approved for commercial use by the Food and Drug Administration (FDA). Renal denervation is a procedure done by introducing a catheter (long tube) into the large blood vessel in your groin (top of leg) and guiding it to your renal arteries, which are the blood vessels that go to your kidneys. The catheter will be placed in the renal arteries and ultrasound energy will be delivered to the renal arteries.
This study is randomized, meaning you will be assigned to one of two groups, by chance, like drawing straws. Two out of three participants will be randomized to renal denervation while one out of three will be randomized to sham. Sham means you will go through all the steps of the procedure but will not receive the treatment. Those participants randomized to sham will have the option to crossover and have the procedure after the 6 month follow up.
This study will involve at least 12 visits over the course of 36 months. Study related procedures include CT scan, ultrasound test of your heart and kidneys, blood work, urine studies, physical exams, questionnaire, and keeping home blood pressure diaries.
Study related risks include risks related to the procedure including pain, bleeding, damage to the blood vessels, risks related to the study related testing such as radiation risks, blood draw risks and loss of confidentiality. There may be benefit to you as well as others in the future with high blood pressure.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

The Influence of Specific, Contextual and Nonspecific Effects on Clinical Outcomes in Individuals with Neck Pain.

Date Added
December 13th, 2024
PRO Number
Pro00139135
Researcher
Bryan O'Halloran

List of Studies

Keywords
Muscle, Pain, Physical Therapy, Rehabilitation Studies
Summary

We are looking to examine the various factors that contribute to the changes seen with Physical Therapy for chronic neck pain. These factors include the components of care involving the way a patient perceives their pain or disability, as well as the interaction with their care giver, which contribute to the effect of the Physical Therapy (PT) treatment. The study will assign subjects to one of three groups. The first group will receive a manual therapy treatment approach, the second will receive a simulated manual therapy treatment approach and the third will receive no treatment and act as a waitlist control. This design will allow us to tease out the effects of the treatment itself compared with the other factors which may contribute to change as well as any improvement which occurs as result of natural history. You will be seen for an initial assessment where you will complete surveys and measurements will be performed looking at how far you can move and the way that you move your neck. You will then be seen for 3 additional visits weekly over the next three weeks if you are assigned to the manual therapy or simulated manual therapy group. You will be seen for an initial visit and a follow up after three weeks if you are assigned to the waitlist/control group. All groups will complete the surveys and have repeat measurements performed at the final follow up visit.

Institution
MUSC
Recruitment Contact
Bryan O'Halloran
8437928224
ohallora@musc.edu

Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing with a Left Ventricular Epicardial Lead in Patients with Heart Failure (HF) with Left Ventricular Ejection Fraction (LVEF) ≤ 50% and with either a Wide QRS Complex (> 130 ms) or with/anticipated > 40% Pacing Randomized Clinical Trial (RCT) (Left vs Left RCT)

Date Added
December 17th, 2024
PRO Number
Pro00140157
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart, Men's Health, Women's Health
Summary

The purpose of this study is to determine if patients with heart failure (HF, meaning a weak heart) with left ventricular ejection fraction (LVEF) ≤ 50% and with an abnormal heart beat can benefit from having pacemaker leads placed in a different location in the heart. We know that people with a weak heart and an abnormal heart beat can benefit from having a pacemaker. Participants in this study will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:
A. Pacing the heart from two locations in the left ventricle (lower left chamber of the heart)
B. Pacing the heart from one of two other places in the heart (the "His" or the left bundle branch)

The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1

Date Added
December 30th, 2024
PRO Number
Pro00141056
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The main objective of this study is to test a once-weekly HIV medication regimen in persons who have not taken HIV treatment before. The goal is to see if taking a once a week pill combination (GS-1720 and GS-4182) works as well as taking a daily pill Biktarvy® (B/F/TAF). Participants will either take the weekly pill or continue with Biktarvy® for about 48 weeks or longer. The study will look at how well each option controls HIV levels.

Institution
MUSC
Recruitment Contact
Jamila Williams
(843) 792-1088
keithja@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy

Date Added
January 6th, 2025
PRO Number
Pro00139544
Researcher
Kimberly Hashemi

List of Studies

Keywords
Lupus, Skin
Summary

This is a Phase III, multicenter, multinational, operationally seamless 2-stage study. The study will be conducted in 2 stages: Stage 1 and Stage 2. Participants will take part in either Stage 1 or Stage 2.Each stage has a randomized, 24-week double-blind, placebo controlled study period (Week 0 to Week 23), to evaluate the efficacy and safety of a SC treatment regimen of anifrolumab (120 mg, once weekly dosing) in adult participants with chronic and/or subacute CLE. The primary endpoint will be assessed at Week 24. The doubleblind, placebo-controlled study period of 24 weeks will be followed by an open-label, uncontrolled treatment period in which all participants will receive SC treatment with anifrolumab (120 mg, once weekly) from Week 24 to Week 51. After the open label treatment period, participants will enter a 12-week Safety Follow-up Period. The study will be performed in approximately 460 adult participants aged 18 to 70 years (inclusive). Stage 1 of the study is planned to be performed in approximately 100 participants (n ~ 50 per treatment arm). Stage 2 of the study is planned to be performed in approximately 360 participants (n ~ 180 per treatment arm).

Institution
MUSC
Recruitment Contact
Jordan Gertz
843-876-3209
gertzj@musc.edu

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Date Added
January 14th, 2025
PRO Number
Pro00141768
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the PulseSelect™ PFA System which is approved by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 2 years and include up to 6 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu



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