A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin Save

Date Added
July 23rd, 2019
PRO Number
Pro00089429
Researcher
Robert Grubb

List of Studies

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

This study is for patient that have bladder cancer and have been treated with BCG (Bacillus Calmette-Guerin), but the cancer has returned after treatment(s). This research study is designed to test if an investigational agent named BC-819 can prevent or delay tumor recurrence in non-muscle invasive bladder cancer patients who have become unresponsive to BCG treatment.
The primary objective is to determine, for the patients with baseline CIS:The proportion that achieves a complete response after treatment with inodiftagene vixteplasmid Participants can expect to be in this study for102 weeks.

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma Save

Date Added
July 18th, 2019
PRO Number
Pro00087838
Researcher
John Kaczmar

List of Studies

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

This study is for patients that have been diagnosed with with resectable High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The investigational drug used in this study is Pembrolizumab. The purposes of this study are to: determine how well pembrolizumab keeps the cancer from coming back or spreading as compared to placebo, determine if giving pembrolizumab after surgery and radiation helps patients live longer, and to test the safety of the study drug and see how patients' bodies handle it. Participants can expect to be in this study for about 8 years. This includes the time that participants will be on study drug and in follow up to see if the cancer has come back or spread.

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

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy Save

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies

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Keywords
Body Composition, Cardiovascular, Drug Studies, Healthy Volunteer Studies, HIV / AIDS, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu

Human Laboratory Study of ANS-6637 for Alcohol Use Disorder Save

Date Added
July 2nd, 2019
PRO Number
Pro00090068
Researcher
Sarah Book

List of Studies


Profiles_link
Keywords
Alcohol, Central Nervous System, Drug Studies, Stage II, Substance Use
Summary

This is a 6-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, ANS-6637, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to take one of two doses of ANS-6637 or a matched placebo.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-8601
voronin@musc.edu

Varenicline as a Treatment for DSM 5 Cannabis Use Disorder in Adults Save

Date Added
July 2nd, 2019
PRO Number
Pro00089933
Researcher
Aimee Mc Rae

List of Studies


Profiles_link
Keywords
Drug Studies, Substance Use
Summary

Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

A Placebo-Controlled, Multi-dose, Phase 2/3 Study to Determine the Safety, Tolerability and Effect on Liver Histologic Parameters in Response to ARO-AAT in Patients with Alpha-1 Antitrypsin Deficiency (AATD) Save

Date Added
June 11th, 2019
PRO Number
Pro00088982
Researcher
Charlie Strange

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary, Rare Diseases
Summary

Alpha-1 Antitrypsin (AAT) is a naturally occurring protein involved in the protection of lungs from inflammation. A mutation in the AAT gene (a change in the body's genetic instructions on how to make AAT) causes it to be made incorrectly and very little of it gets into the bloodstream.This results
in the lung damage known as emphysema. ARO-AAT is an investigational drug, which means that it is not approved by the Food and Drug Administration. ARO-AAT works by interrupting a step in the production of AAT. In a patient with AATD, this would stop the mutated protein from being made. This study is being carried out to see how safe and well tolerated ARO-AAT is, and to see if low, medium and high doses of the study treatment will decrease Alpha-1 Antitrypsin in the blood and in the liver compared to a placebo, or dummy injection. The Study medication is given via injection on Day 1, 29 and 133 and then every 84 days. The study includes approximately 17 visits over a period of 24 month. Compensation will be provided for study site visits. .

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-792-8438
blantonm@musc.edu

Phase 1/2 Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia (AML) Save

Date Added
June 11th, 2019
PRO Number
Pro00088311
Researcher
Robert Stuart

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with AML, with a mutation, or change, in the FLT3 gene. The investigational drug in this study is gilteritinib (ASP2215). The purpose of this research study is see if a medicine called gilteritinib (ASP2215) given in combination with atezolizumab is both effective and safe as a treatment for AML patients with a mutation, or change, in the FLT3 gene. Participants can expect to be in this study for roughly 2 years.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release Save

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies

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Keywords
Cancer, Cancer/Leukemia, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (Artemis-IGAN) Save

Date Added
May 14th, 2019
PRO Number
Pro00083397
Researcher
Anand Achanti

List of Studies


Profiles_link
Keywords
Drug Studies, Kidney
Summary

This study will use a new investigational study drug called OMS721 in people with Immunoglobulin A (IgA) Nephropathy. OMS721 is an antibody, which is a type of protein that can bind to substances in the body. OMS721 is being studied because it blocks a key enzyme (a protein that causes specific chemical changes in the body) in the blood that may be responsible for causing the damage in IgA Nephropathy.
The study is approximately 23 visits over a period of 3 years. The study drug is administered via a 30-minute intravenous infusion once a week for 12 weeks. You will then be evaluated to determine your response to the drug and followed-up with regularly. Possible re-treatment is determined by the study doctor.

Institution
MUSC
Recruitment Contact
Kellean Van Cleef
843-792-8166
vancleef@musc.edu

A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale Save

Date Added
April 23rd, 2019
PRO Number
Pro00086734
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Skin
Summary

This is a multi-center study of the safety and effectiveness of an experimental study drug in treatment of subjects diagnosed with moderate to severe lamellar ichthyosis (LI). The investigational cream will be applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. Participation in the study will last 12 weeks (approximately 6 visits) with the option to continue for another 12 weeks (approximately 5 visits) for a total study duration of up to 24 weeks in total. Compensation may be provided.

Institution
MUSC
Recruitment Contact
Charnele Handy
843-792-8008
handyc@musc.edu

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