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Trial record 9 of 104 for:    Recruiting, Not yet recruiting, Available Studies | (idiopathic pulmonary fibrosis)

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 : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date December 11, 2014
First Posted Date December 12, 2014
Last Update Posted Date September 18, 2019
Actual Study Start Date January 28, 2015
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2018)
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.
Original Primary Outcome Measures
 (submitted: December 11, 2014)
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 ]
Change History Complete list of historical versions of study NCT02315586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 25, 2019)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis
Official Title Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis
Brief Summary

Background:

- 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.

Objectives:

- To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs that may be used to treat pulmonary fibrosis.

Eligibility:

  • People at least 18 years old with IPF.
  • Healthy volunteers at least 18 years old.

Design:

  • 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.
Detailed Description Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive disease that occurs primarily in older individuals, 55 to 75 years of age, with a median survival of approximately 3 years from time of diagnosis. At present, there are no effective treatments for patients with IPF. Levels of apolipoprotein A-I (apoA-I) have been found to be reduced in the lungs of patients with IPF, while administration of human apoA-I has been shown to reduce bleomycin-induced collagen deposition in a murine model. Here, we would like to assess whether apoA-I pathways modify lung cell biology in patients with IPF. This is a specimen procurement, clinical phenotyping and genotyping protocol that will assess whether holo-apoA-I and apolipoprotein A-I mimetic peptides, can attenuate key pathogenic manifestations of IPF, such as proliferation and extracellular matrix generation by pulmonary fibroblasts, which may serve as evidence to support future human clinical trials of apoA-I for the treatment of IPF. Furthermore, the identification of new apoA-I responsive genes and pathways that mediate fibroblast proliferation in IPF may provide insights into disease pathogenesis and identify new therapeutic targets. Lastly, if induced pluripotent stem (iPS) cells can be successfully shown to model responsiveness of lung cells to apoA-I therapy, then this approach may be expanded with the goal of providing a personalized medicine analysis that could in the future guide selection of the most effective therapy for individual patients.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be enrolled at the NIH Clinical Center. IPF subjects will be recruited from the INOVA Fairfax Advanced Lung Disease Program and study procedures will be performed in the outpatient unit/day hospital at the NIH Clinical Center.@@@
Condition Idiopathic Pulmonary Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 31, 2015)
500
Original Estimated Enrollment
 (submitted: December 11, 2014)
150
Estimated Study Completion Date December 31, 2029
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

Patient:

Males and females over the age of 18 with a diagnosis of IPF.

EXCLUSION CRITERIA:

Patient:

Female subjects who are pregnant or lactating

INCLUSION CRITERIA:

Normal Volunteer:

Males and females over the age of 18 without IPF.

EXCLUSION CRITERIA:

Normal Volunteer:

Female subjects who are pregnant or lactating

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Maryann M Kaler, C.R.N.P. (301) 451-5916 mk371e@nih.gov
Contact: Stewart J Levine, M.D. (301) 402-1553 levines@nhlbi.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02315586
Other Study ID Numbers 150017
15-H-0017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Stewart J Levine, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 13, 2019