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

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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.


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
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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1211 Medical Center Dr
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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171 Ashley Avenue
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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Los Angeles, California 90095
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Los Angeles, CA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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