The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States
University of California
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Overall Safety Profile of Simtuzumab
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.
Time frame: 30 days post last study treatment (up to 165 weeks)
Relative Change From Baseline in FVC % Predicted at 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.
Time frame: Weeks 72 and 144
Relative Change From Baseline in DLCO % Predicted at 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.
Time frame: Weeks 72 and 144
All-cause Mortality
All-cause mortality was assessed as a number of participants who died from any cause.
Time frame: Up to 165 weeks
Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120
Time frame: Weeks 72 and 120
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Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States