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Anti-viral
Glecaprevir and Pibrentasvir for Chronic Kidney Disease (QUICK-CURE Trial)
Phase 4
Waitlist Available
Led By Nahel Elias, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year study period
Awards & highlights
QUICK-CURE Trial Summary
This trial studied the effects of pan-genotypic DAA therapy given to kidney transplant recipients to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney.
Eligible Conditions
- Chronic Kidney Disease
- Hepatitis C
- Kidney Failure
QUICK-CURE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year study period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SVR12
Secondary outcome measures
Adverse Events
Allograft Function
HCV RNA Viral Load
+1 moreQUICK-CURE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with Direct Acting Antiviral for HCVExperimental Treatment1 Intervention
4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pibrentasvir
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,947 Total Patients Enrolled
Nahel Elias, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
University Of Damascus (Medical School)
North Oakland Medical Center (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Requirements for donors who have passed away.You have severe kidney disease (stage 5 CKD or ESRD) and have met the criteria for a kidney transplant at MGH Transplant Center.You have a positive test for the hepatitis C virus (HCV).You are able to fully understand the details of the study and are willing to sign a document stating that you agree to participate.Your kidney has a good score (KDPI score less than or equal to 0.850).You meet the standard criteria for organ donation.You do not have any serious liver conditions at the time of transplantation readiness as assessed by your clinical team.Requirements for being included in the study as a participant.Women must agree to use two forms of birth control, including a barrier method, when taking the study drug to prevent pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with Direct Acting Antiviral for HCV
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- 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.
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