Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    wake forest | ipf
Previous Study | Return to List | Next Study

Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874989
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Mayo Clinic
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE December 16, 2016
Actual Primary Completion Date June 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Percentage of pro-inflammatory expressing cells [ Time Frame: baseline ]
    A skin biopsy will be obtained at baseline and the percentage of pro-inflammatory expressing cells will be recorded
  • Percentage of pro-inflammatory expressing cells [ Time Frame: 4 weeks post baseline visit biopsy/ 5 days post last dose study drug ]
    A skin biopsy will be obtained at 4 weeks post baseline/5 days after the last dose of study medication and the percentage of pro-inflammatory expressing cells will be recorded
  • Blood Pressure [ Time Frame: screening 1 week pre baseline visit ]
  • Blood Pressure [ Time Frame: baseline visit ]
  • Blood Pressure [ Time Frame: 4 weeks post baseline ]
  • Weight [ Time Frame: screening 1 week pre baseline visit ]
  • Weight [ Time Frame: baseline visit ]
  • Weight [ Time Frame: 4 weeks post baseline ]
  • Heart Rate [ Time Frame: screening 1 week pre baseline visit ]
  • Heart Rate [ Time Frame: baseline visit ]
  • Heart Rate [ Time Frame: 4 weeks post baseline ]
  • CBC (complete blood count) [ Time Frame: screening 1 week pre baseline visit ]
  • CBC (complete blood count) [ Time Frame: 4 weeks post baseline ]
  • Lipid Panel [ Time Frame: screening 1 week pre baseline visit ]
  • Lipid Panel [ Time Frame: 4 weeks post baseline ]
  • HbA1c (glycated hemoglobin) [ Time Frame: screening 1 week pre baseline visit ]
  • HbA1c (glycated hemoglobin) [ Time Frame: 4 weeks post baseline ]
  • CMP (comprehensive metabolic panel) [ Time Frame: screening 1 week pre baseline visit ]
  • CMP (comprehensive metabolic panel) [ Time Frame: 4 weeks post baseline ]
  • Plasma hsCRP (high-sensitivity C-reactive protein) [ Time Frame: screening 1 week pre baseline visit ]
  • Plasma hsCRP (high-sensitivity C-reactive protein) [ Time Frame: 4 weeks post baseline ]
  • Plasma IL-6 (inflammatory biomarker) [ Time Frame: baseline ]
  • Plasma IL-6 (inflammatory biomarker) [ Time Frame: 4 weeks post baseline ]
  • Plasma IL-6R (inflammatory biomarker) [ Time Frame: baseline ]
  • Plasma IL-6R (inflammatory biomarker) [ Time Frame: 4 weeks post baseline ]
  • Plasma PASP biomarkers (inflammatory biomarkers) [ Time Frame: baseline ]
  • Plasma PASP biomarkers (inflammatory biomarkers) [ Time Frame: 4 weeks post baseline ]
  • p16INK4a biomarker (inflammatory biomarker) [ Time Frame: baseline ]
  • p16INK4a biomarker (inflammatory biomarker) [ Time Frame: 4 weeks post baseline ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
Reduction in the % of pro-inflammatory expressing cells [ Time Frame: 3 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial
Official Title  ICMJE Targeted Removal of Pro-Inflammatory Cells: An Open Label Human Pilot Study in Idiopathic Pulmonary Fibrosis
Brief Summary The study team hypothesizes that intermittent (3 doses administered over 3 consecutive days in 3 consecutive weeks) oral administration of combination Dasatinib (100 mg/d) + Quercetin (1250 mg/d) will be safe and well tolerated in patients with IPF. Treatment with D+Q will result in reduced abundance of pro-inflammatory cells within subjects over baseline. Finally, the reduction in biomarkers of cellular pro-inflammatory state will be related to no change in functional and patient reported outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Some patients will be randomized either to placebo or study drug and other patients will go into open label.
Primary Purpose: Basic Science
Condition  ICMJE Idiopathic Pulmonary Fibrosis (IPF)
Intervention  ICMJE
  • Drug: Dasatinib + Quercetin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Dasatinib + Quercetin
    Intervention: Drug: Dasatinib + Quercetin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Justice JN, Nambiar AM, Tchkonia T, LeBrasseur NK, Pascual R, Hashmi SK, Prata L, Masternak MM, Kritchevsky SB, Musi N, Kirkland JL. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. EBioMedicine. 2019 Feb;40:554-563. doi: 10.1016/j.ebiom.2018.12.052. Epub 2019 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2016)
7
Actual Study Completion Date  ICMJE June 3, 2019
Actual Primary Completion Date June 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men between ages 50 and above, at the time of signing the informed consent.
  2. Post-menopausal women ages 50 and above, at the time of signing the informed consent. Note: Postmenopausal is defined as 12 months of spontaneous amenorrhea determined by self-report.
  3. A clinical diagnosis of IPF and characteristic chest HRCT scan (determined by panel of pulmonary radiologists) OR biopsy showing usual interstitial pneumonia (UIP).
  4. Body Mass Index (BMI) within the range 19 - 39.9 kg/ m2 (inclusive), where BMI = (weight in kg) / (height in meters)2 .
  5. Subjects participating in an exercise program must be willing to maintain their current activity level for the duration of the study period.
  6. Patients on stable therapy with nintedanib (Ofev) or pirfenidone (Esbriet) over the past 3 months.ORPatients not taking nintedanib (Ofev) or pirfenidone (Esbriet) may be enrolled if they have previously not tolerated one of those medications or if those medications have not yet been prescribed or used by the patient.
  7. Giving signed informed consent.
  8. No plans to travel over the next 6 weeks.

Exclusion Criteria:

  1. More than two moderate/severe IPF exacerbations within the past year Exacerbation is defined as worsening of two or more of the following major symptoms: dyspnea, sputum volume, sputum purulence OR worsening of any one major symptom together with at least one of the following additional symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever > 37.5 ° C without any explained cause, increased cough, increase wheeze.

    A moderate exacerbation is defined as an event that is associated with a new prescription for antibiotics and/or oral steroids. A severe exacerbation is defined as an event that is associated with hospitalization or emergency room visit.

  2. Any moderate/severe IPF exacerbation within the past 4 weeks.
  3. History of a lung transplant.
  4. Use of anti-arrhythmic medications known to cause QTc prolongation.
  5. Pulmonary hypertension or cor pulmonale confirmed by echocardiography or heart catheterization.
  6. Myocardial infarction, angina, hospitalization for cardiac aetiology, stroke or transient ischemic attack in the past 6 months.
  7. Chronic heart failure.
  8. Neurologic, musculoskeletal, or other condition that in the opinion of the study physician limits subject's ability to complete study physical assessments.
  9. Uncontrolled diabetes (HbA1c > 8% and fasting glucose >200 mg/dL or the current use of insulin).
  10. Subjects with values outside the specified ranges for the following Key Clinical Laboratory Tests must be excluded from the study:

    Renal function: Glomerular Filtration Rate (GFR) <30 (mL/min/1.73 m2) using formulae provided in the Study Reference Manual (SRM). Note: Subjects receiving dialysis are excluded from this study.

    ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

  11. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  12. QTcB or QTcF > 450 msec or QTc > 480 msec in subjects with Bundle Branch Block based on a single ECG.
  13. Subjects with a history of malignancy that is not in complete remission for at least 2 years or 1 year for non-melanoma skin carcinoma.
  14. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to participation in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  15. History of drug or alcohol abuse within 5 years prior to randomization.
  16. Use of Coumadin or other anti-platelet or anti-coagulant medication. The use of aspirin is permitted.
  17. Current use of quinolone antibiotics.
  18. Low CBC.
  19. Cognitive Impairment (MoCA score less than 21)
  20. Other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874989
Other Study ID Numbers  ICMJE IRB00037000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE
  • Mayo Clinic
  • The University of Texas Health Science Center at San Antonio
Investigators  ICMJE
Principal Investigator: Stephen Kritchevsky, PhD Wake Forest Univerisity Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP