NCT05988463

Open-Label Dose-Escalation Treatment Study of Patients With IPF

A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Idiopathic Pulmonary Fibrosis
Joseph C. Wu·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Artesunate Oral Product
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Joseph C. Wu
Funder
Stanford University
Location
Stanford, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Nov 01, 2023
End date
Nov 01, 2024
Enrollment
10 participants
Primary outcome

Number of participants who experience treatment-related adverse events

Summary

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 . The goal of this open-label (no placebo) study is to evaluate the safety and
 tolerability of artesunate at three different doses in patients with IPF. The secondary goals
 are to explore the blood biomarkers present in IPF patients at the beginning of the study and
 to study how those biomarkers change following treatment with artesunate. Participants will
 have 7 visits to the study site over 20 weeks which will include physician exams, vital
 signs, questionnaires, research and safety blood samples, and taking artesunate capsules by
 mouth for 12 weeks.
 
 Artesunate is used world-wide for the treatment of severe malaria but has also been found to
 block specific proteins that cause lung scarring and may provide an additional treatment to
 slow the fibrotic process in the lung and improve survival and quality of life for patients
 with IPF.

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05988463
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05988463 through Pure Global AI's free database. This Phase 1 trial is sponsored by Joseph C. Wu and is currently Not yet recruiting. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.