Long-Term Safety Study of GS-6624 to Treat Idiopathic Pulmonary Fibrosis (IPF)
Status: | Terminated |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2012 |
End Date: | February 2016 |
A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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.
participants with Idiopathic Pulmonary Fibrosis (IPF) who had previously participated in
Gilead clinical trial AB0024-201.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Gilead Sciences -6624
We found this trial at
6
sites
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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