A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

• Conditions: Idiopathic pulmonary fibrosis; MedDRA version: 16.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001571-36-ES
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Male or female subjects from 45 to 85 years of age
2. Diagnosis of definite IPF according to American Thoracic
Society/European Respiratory Society (ATS/ERS) Consensus Statement,
using HRCT or surgical lung biopsy (SLB) (both to be confirmed by a
central service); the diagnosis must be made within 3 years prior to
screening
3. 6MWD ? 50 meters (164 feet): use of ? 6 L/min supplemental O2 is
required for all subjects
4. Able to maintain oxygen saturation of ? 89% while breathing room air
at rest
5. Able to perform complete breath hold for diffusing lung capacity for
carbon monoxide (DLCO) measurement
6. Negative serum pregnancy test at screening and negative urine
pregnancy test at randomization for female subjects of childbearing
potential
7. Willingness of female subjects of childbearing potential to undergo
urine pregnancy tests every 28 days
8. Females of childbearing potential must agree to use highly effective
methods of contraception from the screening visit throughout the study
period and for 90 days following the last dose of IMP. Please refer to
Section 8.11.2 for protocol recommended methods of contraception;
females of childbearing potential must have negative serum ?-hCG at
screening.
9. Non-vasectomized male subjects must agree to use a highly effective
method of contraception if sexually active and refrain from sperm
donation from Day 1 throughout the study period
until 90 days following the last dose of investigational medicinal product
(IMP)
10. Lactating females must agree to discontinue nursing before enrolling
in the study and for the duration of the study while receiving IMP
11. Competency to understand the information given in the Institutional
Review Board (IRB) or Independent Ethics Committee (IEC) approved
Informed Consent Form (ICF); subjects must sign the ICF prior to the
initiation of any study procedures/assessments, unless it is performed
as standard of care for this disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Related to other medical conditions or diagnoses:
1. Pregnant or breastfeeding
2. Clinically significant respiratory diseases other than IPF, including
asbestosis, other pneumoconiosis or hypersensitivity pneumonitis
3. Obstructive lung disease determined by Pulmonary Function Test
(PFTs) or HRCT as follows:
? Evidence of reactive airway disease by absolute increase in forced
expiratory volume in 1 second (FEV1) of > 12% following bronchodilator
challenge OR
? FEV1/FVC ratio < age adjusted lower limit of normal (LLN) OR
? Residual volume (RV) > 120% by plethysmography or significant
emphysema on HRCT defined as more emphysema than fibrosis
interpreted by a central radiology service
4. Hemoglobin corrected, not volume corrected, DLCO <25% of predicted
normal
5. Surgical lung biopsy (SLB) showing, pneumoconiosis, hypersensitivity
pneumonitis nonspecific pneumonia or other idiopathic interstitial lung
disease
6. Any collagen vascular disease
7. History of aortic aneurysm ? 3.5cm in diameter
8. History of cerebrovascular accident (stroke) within the preceding 26
weeks
9. Clinically significant heart disease defined as a myocardial infarction
documented by an ST elevation (STEMI) on electrocardiogram (ECG)
within 6 months prior to screening, percutaneous coronary intervention
or coronary artery bypass surgery within 6 months prior to screening,
unstable angina pectoris, congestive heart failure (NYHA class III/IV or known left ventricular ejection fraction < 25%), right heart failure, significant right ventricular hypertrophy, or uncontrolled arrhythmia
10. Require pharmaceutical treatment for pulmonary hypertension
11. Hospitalization for acute respiratory illness < 26 weeks prior to
screening
12. Aspiration pneumonia < 26 weeks prior to screening
13. Active or recent (< 4 weeks prior to enrollment) respiratory
bacterial, viral, fungal, or other infection (defined as exhibiting ongoing
signs/symptoms related to the infection and without improvement)
14. History of cancer, precancerous state (eg, familial polyposis, BRCA1,
BRCA2), other than non-melanomatous skin cancer, within 5 years prior
to screening, or active work-up for suspected lung cancer
15. History of human immunodeficiency virus (HIV), hepatitis C, or
hepatitis B
16. Co-morbid condition or illness limiting life expectancy to < 2 years at
time of screening
17. Major surgery, as defined by the investigator, < 30 days prior to
screening or scheduled elective surgery during the expected duration of
the study
18. History or evidence of a clinically significant disorder, condition, or
disease that, in the opinion of the investigator and the Gilead medical
monitor, would pose a risk to subject safety or interfere with the study
evaluations, procedures, or completion
19. Current excessive (as determined by the investigator) consumption
of alcohol or use of illegal drugs Related to physiologic or organ specific
abnormalities:
20. Use of supplemental O2 > 6L/min during activity
21. Inadequate organ function reflected by any of the following:
? Platelets < 100 x 109/L
? Hemoglobin < 11.0 g/dL
? Absolute Neutrophil Count (ANC) < 1.5 x 109/L
? PT/INR and PTT > 1.5 x upper limit of normal (ULN)
? AST/ALT > 3 x ULN
? Total bilirubin > 1.5 x ULN
? Serum creatinine > 2.0 mg/dL
Related to treatment for IPF or investigational drugs:
22. Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs
including pirfenidone, colchicine, cyclosporine A, TNF-? antagonists,
tyrosine kinase inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified