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Posaconazole for Crohn's Disease
Study Summary
This trial will evaluate the effects of an oral antifungal drug on Crohn's disease activity and the amount of a certain type of fungus in patients with a certain gene. The trial will also investigate whether the changes in the patient's microbiome caused by the antifungal drug are associated with weaker immune responses in people who are genetically predisposed to strong immune responses to the fungus.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not taking drugs that are mainly processed by the liver enzyme CY3PA4.I have active Crohn's disease confirmed by a scope test and symptoms.I am 18 years old or older.I don't have any major health issues that would stop me from joining the study.I have a specific genetic variation linked to increased disease risk.My kidney function is reduced with a creatinine clearance below 50.I do not have a heart condition that can cause irregular heartbeats.I have severe colon issues, including toxic megacolon or need for a stoma.I have been diagnosed with a type of colitis.I haven't taken antibiotics, antifungals, probiotics, or prebiotics in the last two weeks.I have Crohn's disease affecting my ileum or colon for at least 6 months.I've been on stable doses of certain medications for my condition for weeks.I have been on a stable dose of oral corticosteroids for at least two weeks.I am not pregnant, breastfeeding, or planning to become pregnant and agree to use contraception if of childbearing age.I've had the right colon cancer checks for my age and disease stage, with no untreated abnormal growths.
- Group 1: Posaconazole
- Group 2: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the current enrollment figure for this investigation?
"Affirmative, the information on clinicaltrials.gov implies that this research project is currently recruiting individuals for participation. Initially uploaded on August 17th 2022 and amended a day later, 24 participants are needed to be collected from two different sites."
What conditions can be remedied with Posaconazole Delayed Release Oral Tablet?
"Posaconazole Delayed Release Oral Tablet is a common treatment for HIV, as well as candidiasis, immunocompromised patients and prophylactic management of Candida infections."
Does the trial have any vacancies for participants?
"As confirmed on the clinicaltrials.gov website, this trial is actively seeking qualified participants. The listing was first published on August 17th 2022 and revised the day after."
Does this trial offer any inclusion criteria regarding age?
"This clinical trial requires all participants to be aged between 18 and 60, in accordance with the established eligibility criteria."
Are there certain criteria for enrolment in this clinical trial?
"This clinical trial seeks 24 individuals between 18 and 60 years of age who have been diagnosed with ileocolitis. Eligible participants must possess the CARD9 SN12 risk allele, lack the exon 11 protective polymorphism, had appropriate colon cancer screening without undiscovered dysplasia, be on a stable dose of oral corticosteroids (prednisone up to 20 mg/day or budesonide up to 9 mg/day) for two weeks prior to screening, display an SES-CD score above 6 (> 4 if only affecting the ileum) along with active symptoms of Crohn's disease as indicated by C"
What other research is there concerning Posaconazole Delayed Release Oral Tablet's efficacy?
"Currently, 9 active clinical trials are occurring which evaluate Posaconazole Delayed Release Oral Tablet; 2 of these studies have entered the final stage. The majority of research centres are located in Brussels, Bruxelles-Capitale Region De yet 110 different sites globally have been identified to administer this drug."
Has the Food and Drug Administration verified Posaconazole Delayed Release Oral Tablet?
"Our team has given Posaconazole Delayed Release Oral Tablet a score of 3, reflecting the fact that it is an approved treatment and thus has undergone extensive safety testing."
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