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Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic lung disease resulting in increasing shortness of breath, cough, and low oxygen levels as a result of lung tissue scarring . This will be a single-center randomized, double-blinded, placebo-controlled study of 20 weeks including up to 4 weeks for screening, followed by 12 weeks of oral artesunate treatment across 3 dose levels (dose escalation every 4 weeks), and 4 weeks of a washout (follow-up) period in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary objective of the study is to evaluate the safety and tolerability of artesunate at 3 dose levels, and to select the dose(s) to carry forward into additional clinical testing. The secondary objective includes exploring the blood biomarkers present in participants with IPF at baseline and to investigate how those biomarkers change following artesunate treatment. The exploratory objectives include assessing the changes in the K-BILD and Leicester cough questionnaire scores and change in pulmonary function after artesunate administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artesunate | Experimental | Experimental group |
|
| Placebo | No Intervention | Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesuante | Drug | Artesunate capsules administered orally twice daily beginning at 10 mg for 4 weeks, followed by 20 mg for 4 weeks, and then 30 mg for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience treatment-related adverse events | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Wu, M.D, Ph.D. | Contact | (650) 736-2246 | joewu@stanford.edu | |
| Evgenios Neofytou, M.D. | Contact | 6507363346 | neofytou@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Mooney, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D004417 | Dyspnea |
| D005355 | Fibrosis |
| D003371 | Cough |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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RAndomized double blind label, dose escalation treatment study
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Randomization and masking will be done via a medical software.
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| Placebo capsules | Other | Placebo capsules |
|
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |