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Anti-malarial Agent
Artesunate for Idiopathic Pulmonary Fibrosis (DIAMOND Trial)
Phase 1
Waitlist Available
Led By Joshua Mooney, MD
Research Sponsored by Joseph C. Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants, aged 40 years or older
Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines
Must not have
Receiving any nonapproved agent intended for treatment of fibrosis in IPF or Participation in other clinical trials
Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the safety & effectiveness of artesunate in patients with IPF, testing if it can slow lung scarring & improve survival & QoL.
Who is the study for?
This trial is for adults aged 40 or older with Idiopathic Pulmonary Fibrosis (IPF), who are already on stable IPF treatments like nintedanib or pirfenidone. Participants must have a certain level of lung function and agree to use effective birth control. Those with severe other diseases, recent infections affecting lung function tests, specific liver test abnormalities, low hemoglobin levels, or taking certain drugs can't join.
What is being tested?
The study is testing the safety and effects of artesunate oral capsules at three different doses in IPF patients over 20 weeks. Artesunate is known for treating malaria but may help reduce lung scarring in IPF. The study includes regular visits for exams, blood samples to check biomarkers related to fibrosis before and after treatment.
What are the potential side effects?
While not specified here, artesunate's side effects could include headache, dizziness, anemia (low red blood cell count), nausea or vomiting based on its use in malaria treatment. Side effects might vary when used for IPF.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I have been diagnosed with IPF according to the latest guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any experimental drugs for IPF nor am I in another clinical trial.
Select...
I do not have an active infection like bronchitis or pneumonia.
Select...
I am currently on amodiaquine, efavirenz, nevirapine, and ritonavir and will stay on them during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2014 Phase 1 trial • 60 Patients • NCT018684387%
Nausea
7%
Headache
5%
Vomiting
5%
Neutrophil count decreased
4%
Oropharyngeal pain
4%
Diarrhoea
4%
Abdominal discomfort
4%
Blood creatine phosphokinase increased
4%
Hypertriglyceridaemia
4%
Pyrexia
2%
Cough
2%
Arthropod bite
2%
Contusion
2%
Rhinorroea
2%
Abdominal pain
2%
Blood bilrubin increased
2%
Dizziness
2%
Hordeolum
2%
Hypercalcaemia
2%
Chills
2%
Feeling hot
2%
Upper respiratory tract infection
2%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total Receiving Pyronaridine-artesunate Tablets
Total Receiving Pyronaridine-artesunate Granules
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ArtesunateExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artesunate Oral Product
2022
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Joseph C. WuLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Joshua Mooney, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of nintedanib or pirfenidone for my IPF for at least 6 weeks.I am using or willing to use effective birth control during and for 60 days after the study.I have had a sudden worsening of my lung condition in the last 3 months.Your last chest scan showed more damage from emphysema than from fibrosis.I am 40 years old or older.Your lung function needs to be at least 30% of normal, and if you had a lung function test in the last 3 months, that result can be used for this study.I have been diagnosed with IPF according to the latest guidelines.I don't have any major health issues that would exclude me from the study.My liver tests are higher than normal.Your lung function test (FVC) shows that you can breathe out a certain amount of air, and your previous test results from up to 3 months ago can be used.I might get a lung transplant during the study or am on the transplant list.I am not taking any experimental drugs for IPF nor am I in another clinical trial.I do not have an active infection like bronchitis or pneumonia.I am currently on amodiaquine, efavirenz, nevirapine, and ritonavir and will stay on them during the study.Your hemoglobin levels are less than 10.0 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Artesunate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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