Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT02315586|
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : August 21, 2020
- Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that becomes worse over time. There is currently no effective treatment for it. Researchers want to study the disease and learn new ways to treat it.
- To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs that may be used to treat pulmonary fibrosis.
- People at least 18 years old with IPF.
- Healthy volunteers at least 18 years old.
- Participants will be screened with medical history, questionnaire, and physical exam. They will have blood, lung, and walking tests and chest scans.
- All participants will have 1 study visit, including:
- Medical history and physical exam.
- Questions about their breathing.
- Blood tests.
- Breathing tests.
- Six-minute walk test.
- Pregnancy test.
- Chest x-ray (healthy volunteers) or chest CT scan (people with pulmonary fibrosis ).
- Small area of skin may be removed.
- Genetic tests of blood and skin samples. Participants will probably not be informed of any findings. Samples may be used to make stem cells for use in research. Participants may be contacted in the future to give consent for this research.
- Some participants will have repeat visits over many years, repeating many of the study tests.
|Condition or disease|
|Idiopathic Pulmonary Fibrosis|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis|
|Actual Study Start Date :||January 28, 2015|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2029|
Participants will be enrolled at the NIH Clinical Center.
IPF subjects will be recruited from the INOVA Fairfax Advanced Lung Disease Program
- Specimen procurement, clinical phenotyping and genotyping that will assess whether holo-apoA-I and apolipoprotein A-I mimetic peptides, can attenuate key pathogenic manifestations of IPF [ Time Frame: 5 years ]Therefore, we request participation of a maximum of 500 subjects (250 IPF patients and 250 non-IPF subjects) to ensure that we have a sufficient number of samples to achieve the goals of the study.
- The effects of stimulating cultures of primary pulmonary fibroblasts from IPF patients and subjects without IPF with apolipoprotein A-I will also be compared to the effects seen following stimulation with apolipoprotein E [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315586
|Contact: Joni Y Mills, C.R.N.P.||(301) firstname.lastname@example.org|
|Contact: Stewart J Levine, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Stewart J Levine, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|