Phase 4
Completed N=8
Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Source: ClinicalTrials.gov NCT02945150 ↗Enrolled (actual)
8
Serious AEs
50.0%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Undetectable HCV RNA at SVR12 — 8 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Undetectable HCV RNA at SVR12 |
8 | — |
| SECONDARY Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365 |
7; 8; 8; 8; 8; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
- No available living kidney donor
- Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
- On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate 35
- History of liver disease
- Pregnant or nursing (lactating) women
- Cardiomyopathy (LV ejection fraction < 50%)
- Positive crossmatch or positive donor specific antibodies
- Human immunodeficiency virus (HIV) positive
- Hepatitis C virus (HCV) RNA positive
- Hepatitis B virus (HBV) surface antigen positive
- Any contraindication to kidney transplant per MGH center protocol
Data sourced from ClinicalTrials.gov (NCT02945150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.