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Glecaprevir/pibrentasvir for Hepatitis C
Study Summary
This trial will test whether receiving a kidney from a donor with HCV and being treated for HCV at the same time is safe and effective for people waiting for a kidney transplant.
- Hepatitis C
- Kidney Failure
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 4 trial • 10 Patients • NCT04575896Trial Design
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Who is running the clinical trial?
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- Waiting for a first or second kidney transplant.You plan to have surgery to replace more than one organ.You plan to receive two kidneys at the same time for a transplant.You do not have anyone who can donate a kidney to you.Your calculated panel reactive antibodies against human leukocyte antigens (HLA) are less than 80%.You have had a solid organ transplant, except for your first kidney transplant.You plan to receive a kidney from a donor with a different blood type than yours.You have a history of HIV, hepatitis C, or active hepatitis B infection.You are 18 years old or older.You are currently on dialysis or have a severe kidney disease with very low filtration rate for a long time.You do not have hepatitis C virus (HCV) and do not engage in behaviors that increase the risk of getting HCV, except if you are on hemodialysis.You are waiting for a kidney from a deceased donor at Johns Hopkins Hospital.
- Group 1: Deceased donor HCV RNA PCR+
- 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.
- 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
How many participants are currently engaged in this research endeavor?
"At this moment, this experimental trial is not actively recruiting participants. The posting of the study was first published on November 20th 2020 and it has been modified as recently as December 7th 2021. For those looking for other trials related to hepatitis c or Glecaprevir/pibrentasvir, there are 458 clinical studies and 11 medical experiments respectively in search of patients."
Are there any slots available for applicants to this clinical investigation?
"Unfortunately, this clinical trial is currently not searching for new candidates. It was initially posted on November 20th 2020 and most recently modified on December 7th 2021. However, there are 458 studies recruiting participants with hepatitis c and 11 trials involving Glecaprevir/pibrentasvir which are actively enrolling patients."
Has Glecaprevir/pibrentasvir been the subject of any prior research studies?
"Currently, Glecaprevir/pibrentasvir has 11 scientific examinations underway with 2 of them being in the final phase. Most studies are conducted in Baltimore, Maryland though there are 115 sites globally that have initiated their own investigations into this treatment."
What is the regulatory status of Glecaprevir/pibrentasvir?
"The safety of Glecaprevir/pibrentasvir is estimated to be 3 on the 1-3 scale due to its Phase 4 status, implying that it has already been approved for use."
What are the leading applications of Glecaprevir/pibrentasvir in current medical practices?
"Glecaprevir/pibrentasvir is administered as a treatment for those that have already attempted an ns5a inhibitor. It can provide relief to individuals with chronic hepatitis c genotypes 5 and 2, or general hep C symptoms."
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