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Tofacitinib for Chronic Granulomatous Disease
Study Summary
This trial is testing a new drug to see if it's safe to use for treating chronic CGD, a disease of the immune system.
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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- Your blood tests show very high levels of certain enzymes, or very low levels of white blood cells.I do not have any health conditions that could affect the study's treatment evaluation.I currently use inhaled tobacco, vaping products, cannabis, or other illicit drugs.I am 18 years old or older.I have IBD, lung, or skin disease related to CGD diagnosed through endoscopy, imaging, or PFTs.I am using a strong CYP3A4 inducer and cannot stop it 14 days before starting tofacitinib.I have had blood clots in my veins or lungs without a clear cause.I am not allergic to tofacitinib, acyclovir, or valacyclovir.I am taking aspirin or NSAIDs that cannot be stopped safely.You currently have an active EBV infection.I am infected with hepatitis B, C, or HIV.I have severe kidney disease.You have had a disease that affects your connective tissues in the past.I have had a gastrointestinal perforation in the past.I am currently being treated for a serious infection.I am currently unable to move around freely.I have a history of heart failure.I have had cancer before, but not skin cancer.I have tuberculosis, whether active or not.
- Group 1: XELJANZ (tofacitinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are people still able to sign up for this clinical trial?
"This clinical trial is not accepting patients at the moment. The listing was originally published on August 12th, 2022 and was last updated September 3rd, 2022. 438 other trials are actively recruiting patients with hepatobiliary disorders while 34 studies for XELJANZ (tofacitinib) currently have open enrolment."
What is the main goal of this research project?
"The primary objective of this study, which will run from Day 1 to Day 120, is to evaluate the rate of treatment-related toxicities. Additionally, the investigators hope to assess the change in modified HBI scores, histopathological endoscopy changes, gene expression IFN-induced module enrichment score, and skin flares or ulcerations captured by photography."
Is XELJANZ (tofacitinib) a new medication?
"At this moment, there are 34 on-going clinical trials assessing the efficacy of XELJANZ (tofacitinib). Of these research projects, 7 have reached Phase 3. While a number of the experiments are based in Shanghai, China; there are 662 locations worldwide where XELJANZ (tofacitinib) is being studied."
How many people have volunteered to take part in this experiment?
"As of right now, this trial is not searching for new participants. However, this could change in the future as the clinical trial was only most recently edited on September 3rd, 2022. For other potential studies, 438 trials are currently enrolling patients with hepatobiliary disorders and 34 XELJANZ (tofacitinib) trials have open enrollment."
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