A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis Save

Date Added
August 28th, 2018
PRO Number
Pro00076525
Researcher
John Huggins

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Keywords
Drug Studies, Lung, Pulmonary
Summary

This is a research study to find out the safety and efficacy of a drug called BG00011 and to find the best dosage. The study drug will be given by an injection under the skin, also called subcutaneously (SC), once a week during the treatment period. Study treatment will be given to you and you will be trained on how to inject yourself with the study drug/placebo in a prefilled syringe. You can ask for re-training at any time during the study. You will be in the study for up to 65 weeks (including a Screening visit, a Study Treatment Period of 52 weeks, and a Safety Follow-Up visit). This study is a randomized, double blind, placebo controlled study.

Institution
MUSC
Recruitment Contact
Allison Patterson
(843) 792-5168
patteallmusc.edu

Crystalloids Liberal Or Vasopressors Early Resuscitation In Sepsis Save

Date Added
August 21st, 2018
PRO Number
Pro00078104
Researcher
Andrew Goodwin

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Keywords
Lung, Pulmonary
Summary

This is a research study of different ways to use intravenous fluids (fluids given through a small tube placed in the vein) and vasopressors (medicines used to raise blood pressure) to treat sepsis, which is a serious infection. We are asking you to be in this study because: a) you have been diagnosed with low blood pressure due to an infection and b) your blood pressure has stayed low after your doctors gave you fluids. We do not know which approach is better in this situation: a)starting medicines to raise blood pressure first and then giving more fluids (if needed), or b) giving a larger amount of fluids first and then giving medicines to raise blood pressure if needed. Right now, the choice of approach is left to the doctors. Some doctors use medicines to raise blood pressure followed by extra fluids, and others use extra fluids followed by medicines to raise blood pressure. Some doctors use a combination of the two. This treatment part of the study will last for 24 hours, and then we will follow you until you go back to where you live. We want to find out whether one of these approaches compared to the other can improve a patient's chances of survival.

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@musc.edu

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, BIOLOGICAL ACTIVITY, AND PK OF ND-L02-S0201 IN SUBJECTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) Save

Date Added
August 14th, 2018
PRO Number
Pro00077835
Researcher
John Huggins

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Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the safety of the study drug ND-L02-s0201 when administered at two dose levels compared with placebo (A placebo looks like the study drug, but the injection does not contain the active ingredient in ND-L02-s0201) to help with IPF. ND-L02-s0201 is being developed to treat fibrosis (scarring) of the lungs. ND-L02-s0201 is made up of tiny particles of fat that contain modified vitamin A and help carry the drug through the body and to reach special cells in the lung. It is hoped that the study drug will slow the progression of fibrosis in your lungs. You will be involved in the study for up to 40 weeks (about 10 months).

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@musc.edu

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Save

Date Added
August 14th, 2018
PRO Number
Pro00078283
Researcher
Patrick Flume

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Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

The purpose of this stuThe purpose of this study is to learn more about the safety and effectiveness of VX-445 used in combination with TEZ and VX-561 in patients with cystic fibrosis. Participation could last for approximately 100 weeks. This will include a treatment period that will last approximately 96 weeks, and a safety follow-up period that will last approximately 4 weeks after the last dose of Study Drug. Approximately 400 people will participate in this study.

Institution
MUSC
Recruitment Contact
Robyn Do
(843) 792-1221
dorobyn@musc.edu

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of PTI-428 in Subjects with Cystic Fibrosis Save

Date Added
July 24th, 2018
PRO Number
Pro00080286
Researcher
Patrick Flume

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Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The is a Phase 2, randomized, double-blind, placebo-controlled study that will be
conducted at multiple centers. The study population is comprised of adult subjects with Cystic Fibrosis, and who have been taking tezacaftor/ivacaftor for the treatment of the disease. The planned sample size is approximately 40 subjects. Participation in this study will last up to approximately 10 weeks and include a screening visit and 9 visits to the study center.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Phase 4 Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects with Pulmonary Sarcoidosis Save

Date Added
June 26th, 2018
PRO Number
Pro00078345
Researcher
Walter James

Silhouette
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this research study is to find out if Acthar works well in and is safe when you use it as part of the treatment for your Pulmonary Sarcoidosis. This research study will collect additional data as to the effectiveness and safety of Acthar in treating Pulmonary Sarcoidosis, and will examine how the study drug acts in the body and how well it manages your symptoms. Participation could last for approximately 56 weeks. This will include a Screening Period that will last up to 4 weeks, a double-blind treatment period of about 6 months when neither you nor your study doctor will know if you are taking Acthar or placebo, an open-label treatment period of about 6 months, and a follow-up visit at about 4 weeks after the last dose of the study drug. The study plan includes coming to the study doctor's research center at least 12 times if you participate throughout the whole study duration of 56 weeks or 9 times if you participate only in the double-blind period.
Approximately 100 people will participate in this study.

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@musc.edu

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study Save

Date Added
June 12th, 2018
PRO Number
Pro00077962
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Lung, Pulmonary
Summary

Physicians currently have difficulty getting a biopsy of lung spots that are far out from the center of the lung. The bronchoscopes that are used to reach these spots currently are sometimes difficult to maneuver and are unable to reach far to these spots because of the large size of the bronchoscope. This study will test a new robotic scope that uses navigation software to find the distant spots in the lung so physicians can get a biopsy.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Save

Date Added
June 12th, 2018
PRO Number
Pro00078198
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

The purpose of this study is learn more about the effectiveness and safety of VX-445 used in combination with TEZ, IVA and VX-561 in patients with cystic fibrosis.
Participation could last for approximately 16 weeks. This will include a Screening Period that will last up to 4 weeks, a Run-in Period that will last up to 4 weeks, a Treatment Period that will last up to 4 weeks, and a Follow-up Period that may last up to 4 weeks after the last dose of Study Drug. Approximately 100 people will participate in this study.

Institution
MUSC
Recruitment Contact
Robyn Do
(843) 792-1221
dorobyn@musc.edu

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Save

Date Added
May 22nd, 2018
PRO Number
Pro00078211
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

In this study, PTI-808 will be given alone and in combination with two other experimental drugs, PTI-801 and PTI-428. PTI-428, PTI-801, and PTI-808 are considered cystic fibrosis transmembrane conductance regulator (CFTR) modulators being developed to treat the underlying mechanism of cystic fibrosis. PTI-428 is a CFTR amplifier that increases the amount of CFTR protein in the cell, PTI-801 is a CFTR corrector that improves the processing of CFTR protein in the cell, and PTI-808 is a CFTR potentiator to enhance the activity of CFTR at the cell surface. Individual modulators have been shown to have limited activity, and therefore it is predicted that a combination of modulators will be required to fully address the CFTR protein defects. The study will also obtain information on how the study drug moves into, through, and out of the body. The expected duration of this study is up to 57 days

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@musc.edu

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Save

Date Added
May 22nd, 2018
PRO Number
Pro00078126
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

The purpose of this study is to learn more about the effectiveness and safety of VX-445 used in combination with TEZ and VX-561 in patients with cystic fibrosis. Participation could last for approximately 32 weeks. This will include a Screening Period that will last up to 4 weeks, a Treatment Period that will last up to 24 weeks, and a Follow-up Period that may last up to 4 weeks after the last dose of Study Drug. Approximately 360 people will participate in this study.

Institution
MUSC
Recruitment Contact
Robyn Do
(843) 792-1221
dorobyn@musc.edu

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