Autoantibody Reduction Therapy in Patients with Idiopathic Pulmonary Fibrosis Save

Date Added
September 20th, 2016
PRO Number
Pro00053229
Researcher
Timothy Whelan
Keywords
Drug Studies, Lung, Pulmonary
Summary

The purpose of this study is to see how well rituximab will work in subjects with Idiopathic Pulmonary Fibrosis (IPF) in terms of reducing autoantibodies (Anitbodies working against the body), and slowing disease progression, compared to a placebo (an inactive pill given as the medication for its suggestive effect).

Approximately 58 people (ages 50-85 years old) will take part study wide and 5 will take part at the Medical University of South Carolina (MUSC). The study will be over the course of nine months and consist of 15 visits.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

Pulmonary Fibrosis Foundation (PFF) Patient Registry and Biorepository Save

Date Added
June 21st, 2016
PRO Number
Pro00055933
Researcher
Timothy Whelan
Keywords
Lung, Pulmonary
Summary

This study is being conducted in order to to create and maintain a database (a searchable collection of information) of subjects with interstitial lung disease (ILD) that collects and stores their medical information, and other related information to use in medical research.

The study is a registry in which the study team will collect information from subjects, but there will be no treatment or intervention involved. Males and females from the ages of 18 years or older diagnosed with ILD are eligible.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) Save

Date Added
May 10th, 2016
PRO Number
Pro00054206
Researcher
Timothy Whelan
Keywords
Drug Studies, Lung, Pulmonary
Summary

This research study includes adults (18 years of age or older) with Idiopathic Pulmonary Fibrosis (IPF). The study is being conducted to find out if KD025 is a safe and effective treatment. Participants will be put on the study drug, KD025, for about 24 weeks (followed by another 24 weeks on KD025 if tolerated well). They will be on a daily dose of 400mg (by mouth) and in previous tests have shown to reduce IPF and inflammation.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A phase 2, randomized, placebo-controlled study of GBT440 to evaluate the safety, tolerability, pharmacokinetics, and effect on hypoxemia in subjects with idiopathic pulmonary fibrosis Save

Date Added
May 10th, 2016
PRO Number
Pro00054346
Researcher
Timothy Whelan
Keywords
Drug Studies, Lung, Pulmonary
Summary

The purpose of this study is to look at how well GBT440 works in people with Idiopathic Pulmonary Fibrosis (IPF) and learn more about its side effects. This study will take place over about 79 days and will compare a group of participants that will receive GBT440 and a group that will receive a placebo (in active pill) for their IPF. Males and females between the ages of 45-80 years with IPF will be eligible.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO) Save

Date Added
May 13th, 2014
PRO Number
Pro00033910
Researcher
Timothy Whelan
Keywords
Lung, Pulmonary
Summary

The purpose of this research registry is to better understand the natural history of Idiopathic Pulmonary Fibrosis and current practice patterns. The IPF-PRO registry will be used to collect data and biological samples that will support future research studies by identifying disease biomarkers for IPF. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some of these studies may be about how genes affect health and disease, or how a person?s genes affect their response to a treatment. Some of these studies may lead to new products, such as drugs or tests for diseases. We are asking you to let us collect and store some of your blood and health information so they might be used in these kinds of future studies.

If you are newly diagnosed with IPF and are eligible for participation in IPF-PRO, you will be asked to sign a consent form to become enrolled if you agree to be in this registry. At enrollment a member of MUSC research staff will collect information from you and about your medical history and medical care, as well as information about the types of health insurance (public or private) that you have. As part of your participation in this registry, you will be required to sign a medical release form giving permission for your medical records to be reviewed for the purposes of data collection for the registry. This is an observational registry which means you will not receive any investigational treatments or investigational drugs, and only minimally invasive procedures will be performed (blood draws) at scheduled clinic visits. In addition to the face to face visits for self-administered participant reported questionnaires and blood collection, at roughly 6-month intervals, sites will review the participant?s medical records. Your disease management and treatment decisions will be determined by you and your health care professional. Subjects will be followed until the last enrolled subject has been followed for 3 years up to a maximum of 5 years.

Institution
MUSC
Recruitment Contact
Allison Barger
843-792-3169
Bargera@musc.edu

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