A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER

Gilead Sciences, Inc.0 sites500 target enrollmentJune 17, 2013

ConditionsIdiopathic pulmonary fibrosis MedDRA version: 18.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Idiopathic pulmonary fibrosis
Sponsor: Gilead Sciences, Inc.
Enrollment: 500
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 17, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Gilead Sciences, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Male or female subjects from 45 to 85 years of age
•2\. A confident diagnosis of IPF consistent with diagnostic criteria described in the 2011 American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. HRCT or surgical lung biopsy data will be interpreted by a central service. The term surgical lung biopsy” encompasses biopsies obtained at open thoracotomy and thoracoscopy, as well as, cryobiopsies obtained through bronchcoscopy. The diagnosis of IPF must have be made within 3 years prior to screening, or if diagnosis was made \> 3 years prior to screening, there must be evidence of clinical worsening within 12 months prior to screening, as judged by the investigator.
•3\. 6MWD \= 50 meters (164 feet): use of \= 6L/min supplemental O2 is permitted.
•4\. Able to maintain O2 saturation of \= 89% while breathing room air at rest at sea level. If the study site is located at more than 1000 meters above sea level, the subject must be able to maintain O2 saturation of \= 89% while on 2 liters of supplemental oxygen at rest (eligible subjects are permitted to use supplemental oxygen during sleep and on exertion based on the clinical judgment of the investigator, to a maximum of 6 liters/minute).
•5\. Able to perform complete breath hold for diffusing lung capacity so that a carbon monoxide (DLCO) measurement can be safely undertaken
•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 at each study visit starting at Randomization
•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 ß\-hCG at screening
•9\. Non\-vasectomized male subjects must agree to use a highly effective method of contraception if sexually active with a partner who is of child bearing potential. Subjects must refrain from sperm donation from Randomization 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

Exclusion Criteria

•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 an increase in forced expiratory volume in 1 second (FEV1\) following bronchodilator challenge that exceeds both 200 ml AND exceeds a 12% increase from the prebronchodilator value OR FEV1/FVC ratio \< age adjusted lower limit of normal (LLN) OR Residual volume (RV) \> 120% by plethysmography (see Section 6\.5 for alternative methods) OR Significant emphysema on HRCT defined as more emphysema than fibrosis interpreted by a central radiology service 4\. FVC \> 90%
•5\. Hemoglobin corrected, not volume corrected, (DLCO) \<25% of predicted normal
•6\. Surgical lung biopsy (SLB) diagnostic for pneumoconiosis, hypersensitivity pneumonitis
•nonspecific interstitial pneumonia or other idiopathic interstitial lung disease
•7\. Any clinically diagnosed collagen vascular disease
•8\. History of aortic aneurysm \= 3\.5cm in diameter
•9\. History of cerebrovascular accident (stroke) within the preceding 26 weeks
•10\. Clinically significant heart disease defined as a myocardial infarction documented by an ST