Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)
|ClinicalTrials.gov Identifier: NCT01759511|
Recruitment Status : Terminated (The Study was terminated due to lack of efficacy.)
First Posted : January 3, 2013
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Simtuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)|
|Actual Study Start Date :||October 18, 2012|
|Actual Primary Completion Date :||February 19, 2016|
|Actual Study Completion Date :||February 19, 2016|
Participants will receive simtuzumab.
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Other Name: GS-6624
- Overall Safety Profile of Simtuzumab [ Time Frame: 30 days post last study treatment (up to 165 weeks) ]The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
- Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144 [ Time Frame: Weeks 72 and 144 ]
- FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.
- Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144.
- Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144 [ Time Frame: Weeks 72 and 144 ]
- DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.
- Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144.
- All-cause Mortality [ Time Frame: Up to 165 weeks ]All-cause mortality was assessed as a number of participants who died from any cause.
- Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120 [ Time Frame: Weeks 72 and 120 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759511
|United States, Arizona|
|Arizona Pulmonary Specialists, Ltd.|
|Scottsdale, Arizona, United States, 85012|
|United States, California|
|University of California|
|Los Angeles, California, United States, 90095|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Gilead Study Director||Gilead Sciences|