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Oral ORIN1001 for Idiopathic Pulmonary Fibrosis
Study Summary
This trial is testing a new drug, ORIN1001, to see if it is safe and effective in treating adults with idiopathic pulmonary fibrosis (IPF). The trial will have 3 groups of 8 people, who will either receive the new drug or a placebo. The trial will last 28 days.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your lungs are not able to absorb carbon monoxide well, as determined by a lung function test.Your lung function is less than 40% of what is expected for someone your age and size.Your lung function test shows that you have trouble breathing out air.You have a stomach or intestine condition that might make it hard for your body to absorb or handle the study drug.You have a liver disease like cirrhosis or long-term liver or bile duct problems.Your SGOT or SGPT levels are more than double the normal range.Your lab test results do not meet the required standards.You are currently taking strong blood thinners or high-dose blood clot prevention medications.You have a known risk of bleeding because of problems with your blood platelets or clotting factors.You have been diagnosed with or likely have a lung condition called idiopathic pulmonary fibrosis (IPF) based on specific medical criteria from 2018.Your hemoglobin levels are lower than 12.9 g/dL if you are a man, or lower than 11.9 g/dL if you are a woman.Your blood clotting tests show that your blood takes longer than normal to clot.You have kidney disease with a low filtration rate.You have had a worsening of your IPF within the last 3 months before joining the study.You don't need to have a lung biopsy if your medical history and high-resolution CT scan suggest a specific type of lung disease.Your liver enzymes AST or ALT are more than 1.5 times the normal level.You have been taking nonsteroidal anti-inflammatory drugs for a long time.You have a heart condition that is not under control.You have had cancer or are currently being treated for cancer in the past year.You had bleeding in your brain within the last year before joining the study.Your platelet count is less than 100 billion per liter.You have diarrhea that is more than mild.
- Group 1: 25 mg ORIN1001 (Active)
- Group 2: 50 mg ORIN1001 (active)
- Group 3: 100 mg ORIN1001 (active)
- Group 4: Placebo - 25 mg
- Group 5: Placebo - 50 mg
- Group 6: Placebo - 100 mg
- 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.
Frequently Asked Questions
Does the study consider applicants aged seventy or above?
"The upper and lower age limits for participants in this trial are 80 and 40 years old, respectively."
To what demographic is participation in this trial limited?
"This research trial is fitting for individuals with usual interstitial pneumonia between the ages of 40 and 80. The recruitment process will involve 24 prospective participants."
Has ORIN1001 been validated for use by the Food and Drug Administration?
"ORIN1001 has not been extensively tested in clinical trials, thus it received a score of 1 with respect to safety."
Is enrollment in this experiment currently available?
"Indeed, according to clinicaltrials.gov's records, this research project is currently admitting participants. Initially posted on February 9th 2021 and last updated on September 20th 2022, the study requires 24 willing volunteers at 12 different sites."
How many individuals are engaging with this medical trial?
"Affirmative, the information on clinicaltrials.gov attests that this scientific research is currently recruiting applicants. The endeavour was initially published on February 9th 2021 and has recently been updated as of September 20th 2022. It requires 24 persons to be enrolled in 12 separate medical centres."
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