Health Condition 1: J709- Respiratory conditions due to unspecified external agent
Conditions
Interventions
Intervention1: Artesunate tablets (50 mg): Artesunate will be supplied as 50 mg tablets. Tablets will be dispensed in bottles prepared by a licensed compounding pharmacy in compliance with regulatory
Sponsors
Areys Biosciences
Klinera Global services
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age forty years or older. 2. Diagnosis of idiopathic pulmonary fibrosis based upon ATS ERS JRS ALAT two thousand eighteen guidelines. 3. Forced vital capacity percent of predicted greater than or equal to forty percent. Historical forced vital capacity for entry in the study is permitted if within three months of screening. 4. Diffusing capacity of lung for carbon monoxide, hemoglobin adjusted, greater than or equal to thirty percent. Historical diffusing capacity for entry in the study is permitted if within three months of screening. 5. Participants currently receiving treatment for idiopathic pulmonary fibrosis with nintedanib or pirfenidone are allowed, provided these drugs have been given at a stable dose for at least six weeks, and taken with no or rare interruption before the screening visit. Stable dose is defined as the highest dose tolerated by the participant during at least six weeks. 6. Female participants of childbearing potential, that is ovulating, premenopausal, and not surgically sterile, and all male participants with sexual partners of childbearing potential agree to use highly effective methods of birth control during their participation in the study and for sixty days after the last administration of study drug. Highly effective methods of birth control are defined as those with ninety nine percent or greater efficacy. Participants must agree to abstain from egg or sperm donation through 60 days after administration of the last dose of study drug. 8. Able to read and sign a written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Receiving any non approved agent intended for treatment of fibrosis in idiopathic pulmonary fibrosis or participation in other clinical trials. 2. Clinical evidence of active infection including but not limited to bronchitis, pneumonia, or sinusitis that can affect forced vital capacity measurement during screening. 3. Known acute idiopathic pulmonary fibrosis exacerbation or suspicion by the investigator of such within three months of screening. 4. The extent of emphysema is greater than the fibrotic changes on the most recent high resolution computed tomography scan as determined by the principal investigator. 5. Any medical condition, including but not limited to cardiac, hepatic, renal disease or malignancy in recent months that will make the patient unsuitable for the study as judged by the principal investigator. 6. Any of the following liver test criteria above specified limits total bilirubin greater than two times the upper limit of normal, aspartate aminotransferase or alanine aminotransferase greater than three times the upper limit of normal, alkaline phosphatase greater than two point five times the upper limit of normal, pending principal investigator discretion. 7. Hemoglobin less than ten gram per deciliter. 8. Pregnant or lactating participants. 9. Participants likely to undergo lung transplantation during the study although being on a transplantation list is acceptable. 10 Currently receiving and expected to remain on treatment during the study with drugs interacting with artesunate including amodiaquine and efavirenz nevirapine and ritonavir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with treatmentrelated AEs and SAEs, including findings from physical examinations and laboratory assessments. 2. Recommended dose of Artesunate for Phase IIb in patients with IPF will be determinedTimepoint: 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in forced vital capacity from screening to end of treatment Change in forced expiratory volume in one second from screening to end of treatment Change in diffusing capacity of lung for carbon monoxide from screening to end of treatment Change in quality of life assessed using King Brief Interstitial Lung Disease questionnaire from baseline Change in Leicester cough questionnaire score from baseline Change in six minute walk distance from baseline Timepoint: 24 week | — |
Countries
India
Contacts
Public ContactDr Samir Gami
Unique Hospital Multispeciality and Research Institute
Outcome results
None listed