A 52-week, open-label, single arm study to investigate the efficacy and safety of mepolizumab SC in participants aged 6 to 17 years with hypereosinophilic syndrome.

Date Added
September 8th, 2021
PRO Number
Pro00113422
Researcher
Kelli Williams

List of Studies


Keywords
Adolescents, Allergy, Pediatrics
Summary

The purpose of this study is to see if taking mepolizumab is safe and effective in treating Hypereosinophilic syndrome (HES) in children and adolescent patients ages 6 to 17 years who are receiving standard of care (SoC) therapy. Mepolizumab is administered through a subcutaneous injection (shot). Participation in the study will last for about 64 weeks approximately (1 year and 3 months).

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults with Hypereosinophilic Syndrome (HES)

Date Added
May 3rd, 2022
PRO Number
Pro00119532
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Rare Diseases
Summary

The purpose of this study is to see if taking depemokimab is safe and effective in treating Hypereosinophilic syndrome (HES) in adults (≥18 years) with uncontrolled HES receiving standard of care (SoC) therapy. The study will last approximately 52 weeks and is a placebo-controlled, double blind, multicentre study.

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)

Date Added
June 6th, 2023
PRO Number
Pro00126684
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

Qutenza® 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy: A Prospective Study.

Date Added
May 28th, 2024
PRO Number
Pro00136049
Researcher
Matthew Sherrier

List of Studies

Keywords
Healthy Volunteer Studies, Pain
Summary

This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to your skin.

If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they will be treated with Qutenza 8% capsaicin topical system and can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if you will need to be retreated at each visit based on your symptoms). This is an open-label study and all participants will receive Qutenza 8% capsaicin topical system. The study visits are estimated to take 90 minutes upwards to 120 minutes.

Institution
MUSC
Recruitment Contact
Jenna Williams
843-792-6639
wiljenna@musc.edu

(SUMMIT) A MULTI-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 CLINICAL STUDY OF THE SAFETY AND EFFICACY OF CGT9486 IN SUBJECTS WITH NONADVANCED SYSTEMIC MASTOCYTOSIS

Date Added
June 21st, 2024
PRO Number
Pro00136659
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Nonadvanced Systemic Mastocytosis. The investigational drug is known as bezuclastinib and will be taken daily orally. Participation in the study is expected to be approximately 3 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Arthrex Products used for Knee Sports Medicine Repair and Reconstruction

Date Added
October 15th, 2024
PRO Number
Pro00132834
Researcher
Harris Slone

List of Studies


Keywords
Joint
Summary

The study is for subjects that are undergoing knee surgery to repair and reconstruct the ligaments and tendons in the knee. Data will be collected to evaluate the continued safety and effectiveness of the screws and anchors that are used during the surgery to do the repair and reconstruction of the ligaments and tendons in the knee. There are six visits over a two-year time period that will be conducted during your standard of care visits with the doctor. During those visits outcome data will be collected via questionnaires. The study is designed to collect real world data from the general population on products that are cleared for sale in the U.S.

Institution
MUSC
Recruitment Contact
Jenna Williams
843-876-0111
wiljenna@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 Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Participants 12 to < 18 Years of Age with Asthma (ACADIA)

Date Added
February 6th, 2025
PRO Number
Pro00140063
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The purpose of this study is to compare BDA MDI with AS MDI on severe asthma exacerbations in adolescent participants aged 12 to < 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. Participants will administer randomized IMP as needed as they normally would with their own prescribed rescue inhaler.

Institution
MUSC
Recruitment Contact
Sydnee Pearson
8437926690
pearsosy@musc.edu



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