Clinical trial for HCV
Official title Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients
ClinicalTrials.gov ID: NCT05653232
What this study is testing
- What it's testing
- The study aims to find the best timing for giving hepatitis C medication to people who receive a kidney from a donor with the virus.
- Who it's for
- It is for adults who are HCV‑negative and are getting a kidney from an HCV‑positive donor.
- What's involved
- Participants are randomly assigned to start the medicine before the transplant and take it for 2 weeks, or to start it after the transplant and take it for 12 weeks. They will have regular visits and blood tests to monitor the treatment.
- Time commitment
- The study lasts about 12 weeks after the transplant, with several clinic visits and blood tests during that time.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant meets the standard criteria for KT at local center.
- Participant is able to understand and provide informed consent.
- Participant is ≥ 18 years old.
You likely can't join if
- Participant has active HCV infection (detectable HCV RNA) at time of screening.
- Participant has cirrhosis or advanced liver fibrosis.
- Participant's aspartate aminotransferase (AST) or ALT \> 2.5 times the upper limit of normal (ULN), within 60 days of screen.
- Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
- Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
- Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply...
See the full eligibility criteria
- Participant meets the standard criteria for KT at local center.
- Participant is able to understand and provide informed consent.
- Participant is ≥ 18 years old.
- Participant has active HCV infection (detectable HCV RNA) at time of screening.
- Participant has cirrhosis or advanced liver fibrosis.
- Participant's aspartate aminotransferase (AST) or ALT \> 2.5 times the upper limit of normal (ULN), within 60 days of screen.
- Participant has human immunodeficiency virus infection (HIV), or active hepatitis B (HBV) infection.
- Participant is unable to safely substitute or discontinue a medication that is contraindicated with the study medication.
- Past or current medical problems, which may pose additional risks from participation in the study, interfere with the participant's ability to comply with study, or impact the quality of the data obtained from the study.
- Participant is pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Loma Linda, California, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Loma Linda, California, United States; Baltimore, Maryland, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States; Richmond, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.