Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT01759511
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
- Previous participation in Phase 1 Gilead clinical trial
- Diagnosis of idiopathic pulmonary fibrosis
- Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
- Females must discontinue nursing
- Comply with study requirements
- Have adequate organ function
Key
- History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
- Pregnant or lactating
- Clinically significant heart, hepatic or renal disease
- History of cancer within 5 years of screening
- Infection that is not controlled despite antibiotics or other treatment
- History of bleeding diathesis within the last 6 months of Day 1
- Known history of human immunodeficiency virus, hepatitis B or C
- Concern's for subjects compliance
- Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
- Placed on a lung transplant list
- Previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Simtuzumab Simtuzumab Participants will receive simtuzumab.
- Primary Outcome Measures
Name Time Method Overall Safety Profile of Simtuzumab 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.
- Secondary Outcome Measures
Name Time Method Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144 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 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 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 Weeks 72 and 120
Trial Locations
- Locations (6)
Arizona Pulmonary Specialists, Ltd.
🇺🇸Scottsdale, Arizona, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, 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