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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01759511 |
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Date of registration:
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15/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
ATLAS |
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Scientific title:
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A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF) |
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Date of first enrolment:
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October 18, 2012 |
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Target sample size:
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34 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01759511 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Gilead Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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Key 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
Key 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 simtuzumab
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Simtuzumab
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Primary Outcome(s)
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Overall Safety Profile of Simtuzumab
[Time Frame: 30 days post last study treatment (up to 165 weeks)]
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Secondary Outcome(s)
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Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144
[Time Frame: Weeks 72 and 144]
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Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144
[Time Frame: Weeks 72 and 144]
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All-cause Mortality
[Time Frame: Up to 165 weeks]
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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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Secondary ID(s)
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GS-US-322-0206
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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