Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus… (NCT01559844) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
United States61 participantsStarted 2012-03
Plain-language summary
The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA \< LLoQ) at 12 weeks post-transplant.
Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48 weeks in the pretransplant treatment will have a second baseline at Week 24 for combined analysis in the pretransplant retreatment phase.
Participants who undergo liver transplant will stop all study drug 24 hours prior to transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing and able to provide written informed consent
✓. Males or females, age \> 18 years old
✓. Males must agree to consistently and correctly use a condom while their female partner agrees to use an approved form of birth control from the date of screening until 7 months after their last dose of ribavirin.
✓. Confirmation of chronic HCV infection documented by at least one measurement of serum HCV RNA above the LLOQ measured at screening, and at least one of the following:
✓. HCV RNA \> 10\^4 IU/mL at screening
✓. Patients meeting the MILAN criteria undergoing liver transplant for HCC secondary to HCV with a MELD of \< 22 and a HCC weighted MELD of ≥ 22.
✓. Child-Pugh Score (CPT) ≤ 7
✓. Planned management of the subject to meet United Network for Organ Sharing (UNOS) criteria, with imaging studies made available for review if required.
Exclusion criteria
✕
What they're measuring
1
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
Timeframe: Posttransplant Week 12
2
Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant
Timeframe: Up to 48 weeks prior to transplant
3
Percentage of Participants With Graft Loss Following Transplant
. Females of child-bearing potential who is pregnant or nursing
✕. Prior exposure to a direct-acting antiviral targeting the HCV nonstructural (NS)5B polymerase
✕. Any transplant patient who has agreed to a liver transplant from a live donor.
✕. Participants requiring planned induction therapy with biologics posttransplantation or with a posttransplantation immunosuppressive regimen not consistent with the following within the first 12 weeks posttransplant:
✕. Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome, among other signs of decompensated cirrhosis.
✕. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cholangitis)
✕. Infection with hepatitis B virus (HBV) or HIV