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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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25 July 2023 |
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Main ID: |
NCT00074698 |
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Date of registration:
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18/12/2003 |
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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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Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
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Scientific title:
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A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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December 8, 2003 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00074698 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and
surgical lung biopsy or according to the American Thoracic Society criteria
Key Exclusion Criteria:
- have a history of significant exposure to organic or inorganic dust or drugs known to
cause pulmonary fibrosis
- have interstitial lung disease other than IPF
- have pulmonary fibrosis associated with connective tissue disease
- have other forms of idiopathic interstitial pneumonia, such as desquamative
interstitial pneumonia, acute interstitial pneumonia, nonspecific interstitial
pneumonia, or cryptogenic organizing pneumonia
- have end-stage IPF (total lung capacity of less than 45% of predicted value)
- are listed for lung transplantation at the time of study enrollment
- have significant heart problems
- are pregnant or lactating (if female)
Other inclusion and exclusion criteria may apply.
Age minimum:
21 Years
Age maximum:
80 Years
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: FG-3019
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Primary Outcome(s)
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
[Time Frame: Baseline up to 12 months]
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Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019
[Time Frame: Through 30 hours postdose]
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Number of Participants With Human Anti-human Antibody (HAHA)
[Time Frame: Baseline up to 12 months]
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Secondary ID(s)
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FGCL-MC3019-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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