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Elexacaftor/Tezacaftor/Ivacaftor + Rifabutin for Drug Interaction
Study Summary
This trial will study how the antibiotic rifabutin affects the way the body processes Trikafta, a medication used to treat cystic fibrosis.
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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- I have a condition that could affect how my body absorbs medication.I am currently breastfeeding.You have a history of uveitis (eye inflammation) or currently have eye or vision problems, except if you wear glasses or contact lenses.My kidney function is reduced.I have liver problems or a history of liver disease.I am a woman who can have children and my pregnancy test was positive.I am between 18 and 65 years old.I am not taking any medications that affect liver enzymes.I have not donated blood (about 1 pint) in the last 56 days.I am willing to stop taking herbal products like grapefruit and St. John's Wort 2 weeks before and during the study.I am using or will use effective birth control or am post-menopausal.I have not had major surgery in the last 4 weeks.You are allergic to rifamycins.
- Group 1: rifabutin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Could you inform me if any past research has been conducted regarding Rifabutin 300mg?
"Presently, there are 26 active scientific investigations for Rifabutin 300mg with the majority at Phase 3. The most common locale is Bochum; however, trials can be found in 1,152 distinct locations across the globe."
How can I participate in this scientific experiment?
"This clinical trial seeks 24 participants that possess a drug-drug interaction and are between 18 to 65 years of age. Moreover, candidates must meet the following criteria: abstain from all herbal or natural health products for two weeks prior to and during the study; BMI between 17.5-30.5 kg/m2 with total body weight over 50kg (110lbs); use reliable contraception if capable of becoming pregnant; postmenopausal females aged one year or more may also be eligible."
Are new participants still being admitted to this trial?
"Yes, the trial is recruiting participants. Initially posted on May 9th 2022 and most recent edited November 7th of this same year, according to information available at clinicaltrials.gov"
Does the study permit minors to participate?
"Participants for this experiment are required to be of age, meaning they must have surpassed 18 years old and not exceeded 65."
How many participants has this trial recruited thus far?
"Affirmative. Clinicaltrials.gov reveals the recruitment of patients for this medical trial, which was posted on May 9th 2022 and last amended November 7th 2022. 24 participants must be recruited from a single clinical site."
What types of ailments is Rifabutin 300mg commonly utilized to address?
"Patients with homozygous f508del mutations in the cftr gene are typically prescribed Rifabutin 300mg. This potent medication can also be utilized to treat HIV, late-stage tuberculosis and as a prophylactic against mycobacterium avium complex infection."
Has the Federal Drug Administration sanctioned Rifabutin 300mg?
"Due to it being a Phase 4 trial and as such, already approved for use, the safety of Rifabutin 300mg is rated at 3 on our scale."
Does this investigation constitute a pioneering clinical exploration?
"Presently, there are 26 clinical trials utilizing Rifabutin 300mg being conducted in 24 countries and 123 cities. The initial trial for the medication began in 2015 under Vertex Pharmaceuticals Incorporated's sponsorship; it included 1044 participants and culminated with its Phase 3 approval. Since then, an additional 112 experiments have been run to further assess safety and efficacy of this drug."
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