Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|