Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System Save

Date Added
November 26th, 2019
PRO Number
Pro00089025
Researcher
Milos Budisavljevic

List of Studies


Profiles_link
Keywords
Blood Disorders, Kidney
Summary

A device called the "Liposorber LA-15 System" has been approved by the
United States Food and Drug Administration for treating kids with focal
segmental glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used,
but the kidneys are still working okay. It can also be used if the subject
has had a kidney transplant and the FSGS comes back after the
transplant. Although the Liposorber System can be used for FSGS, we
are not sure how well the Liposorber System works. So, we are doing this
study to find out how well the treatment works in adults.
In this research study, there will be up to 5 adults who have FSGS
enrolled at MUSC. Subjects will come back for up to 12 treatments over 9
weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia Save

Date Added
September 24th, 2019
PRO Number
Pro00091452
Researcher
Charles Greenberg

List of Studies


Profiles_link
Keywords
Blood Disorders
Summary

The purpose of this study is to test the safety and effectiveness of a new study drug in adults who have warm antibody autoimmune hemolytic anemia (wAIHA). This study aims to determine if participants receiving the study drug, called fostamatinib, respond better than participants receiving placebo (an inactive substance) measured by an increase in red blood cell count. Participation in the study will be for a duration of at least 30 weeks with a total of approximately 15 visits to the study clinic.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-5935
hinsone@musc.edu

An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study) Save

Date Added
August 27th, 2019
PRO Number
Pro00091006
Researcher
Charles Greenberg

List of Studies


Profiles_link
Keywords
Blood Disorders, Drug Studies
Summary

The purpose of this study is to evaluate the likely safety and effectiveness of danaparoid sodium versus argatroban for patients suffering from heparin-induced thrombocytopenia (HIT). Patients with HIT will have low blood platelet counts due to being given the medication heparin. Adult and pediatric participants who are determined to be eligible to participate will be assigned by chance to treatment with danaparoid sodium or argatroban. The study drugs are administered through intravenous therapy (IV). Study and safety assessments, including blood draws and compression ultrasounds, will be completed at study visits. Participants will be in this study for at least 45 days, but could receive treatment longer depending on HIT severity. You will be hospitalized while you are receiving study drug treatment for a minimum fo 14 days. You will have 4 study follow-up visits after they have been discharged from the hospital.

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

Monotherapy anticoagulation to expedite home treatment of venous thromboembolism (MATH VTE) Save

Date Added
May 21st, 2019
PRO Number
Pro00085403
Researcher
Andrew Matuskowitz

List of Studies


Profiles_link
Keywords
Blood Disorders
Summary

Previous studies have shown that many patients diagnosed with blood clots in the lungs and limbs can be safely discharged home from the emergency department with blood thinner therapy. However, physician discomfort and prescription medication cost results in many patients being admitted to the hospital. This study aims to show that the majority of low risk patients with blood clots who are started on a blood thinner called apixaban can be safely discharged from the emergency department without having a bad outcome. Specifically, we expect to find that these patients have a very low risk of worsening blood clot or bleeding within the first month after starting apixaban.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

SMYLS: A Self-Management Program for Youth Living with Sickle Cell Disease Save

Date Added
March 17th, 2019
PRO Number
Pro00084400
Researcher
Shannon Hudson

List of Studies


Profiles_link
Keywords
Adolescents, Blood Disorders, Pain, Pediatrics
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile device is helpful for teens learning to care for and manage symptoms of their sickle cell disease. The intervention lasts 12 weeks with a 3-month follow up period, and uses a smartphone or a tablet. For more information, please contact Shannon at 843-792-9379.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE)- Part 2 Save

Date Added
August 25th, 2018
PRO Number
Pro00080391
Researcher
Shannon Hudson

List of Studies


Profiles_link
Keywords
Blood Disorders
Summary

This study is to better understand barriers to and resources for transcranial Doppler (TCD) screening in children with sickle cell anemia (SCA) ages 2 to 16 years. Surveys and interviews are being conducted with children with SCA and their parents/caregivers, healthcare providers, and other stakeholders to learn about their thoughts and experiences.

Institution
MUSC
Recruitment Contact
Joannie Hayes
843-876-8767
hayesj@musc.edu

A phase 2, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, with or without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups of Pediatric Sickle Cell Disease Patients with Vaso-Occlusive Crisis Save

Date Added
August 14th, 2018
PRO Number
Pro00079784
Researcher
Shayla Bergmann

List of Studies

Silhouette
Keywords
Blood Disorders
Summary

This study will assess the appropriate dosing and evaluate the safety of crizanlizumab in pediatric sickle cell disease patients. The study is for male and female subjects between the ages of 6 months to 17 years old who have experienced at least one pain crisis within a 12 month period. The drug is given via an IV infusion in an outpatient setting and has the potential to reduce the amount of sickle cell pain crisis a participant may experience. Participants can expected to participant in this study for up to 2 years.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease (HESTIA3) Save

Date Added
July 24th, 2018
PRO Number
Pro00078866
Researcher
Shayla Bergmann

List of Studies

Silhouette
Keywords
Blood Disorders
Summary

This study will assess the effect of ticagrelor versus placebo in reducing the rate of pain crisis in sickle cell disease patients. The study is for male and female subjects between the ages of 2 to 17 who have experienced at least two pain crisis within a 12 month period. The drug is given by mouth in an outpatient setting and consists of 13 visits over an 18 month period.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of Voxelotor (GBT440) in Pediatric Participants with Sickle Cell Disease Study (HOPE Kids 2) Save

Date Added
May 8th, 2018
PRO Number
Pro00076380
Researcher
Shayla Bergmann

List of Studies

Silhouette
Keywords
Blood Disorders
Summary

This study will assess the safety and efficacy of voxelotor with long term, daily oral dosing compared to placebo in pediatric participants (ages 9 months to 12 years old) with SCD as measured by improvement in anemia. Participants can expected to be in this study for about 52 weeks with at least 12 visits to the study center.

Institution
MUSC
Recruitment Contact
Joannie Hayes
843-876-8767
hayesj@musc.edu

An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical Trials Save

Date Added
April 10th, 2018
PRO Number
Pro00076264
Researcher
Temeia Martin

List of Studies


Profiles_link
Keywords
Blood Disorders
Summary

This open label extension study is being conducted to assess the long-term safety and efficacy of GBT440 by providing participants from GBT440-031 continued access to treatment with GBT440 after completion of their participation in GBT440-031 and prior to the product potentially being available commercially. All participants enrolled into this study will receive GBT440.

Institution
MUSC
Recruitment Contact
Karen Hawkins
843-792-0560
hawkink@musc.edu

Change_preferences

-- OR --

Create_login