Hepatocellular Carcinoma Clinical Trial
Official title:
Open Label Trial to Study the Efficacy and Safety of MK-5172 and MK-8742 +/- Ribavirin (RBV) in the Treatment of Hepatitis C G1 and 4, in Patients Eligible for Liver Transplant (HCC) or Curative Therapy or Clinically Stable Disease Post Local Resection, Embolization or Ablative Therapy
Subjects with Hepatitis C Virus (HCV) infection, genotype 1 or 4 and with hepatocellular carcinoma (HCC) and a complete response to HCC therapy will be randomised to immediate or delayed (6 months) HCV therapy with Elbasvir (MK-8742) and Grazoprevir (MK-5172) [EBR/GZR].
Two cohorts (A and B) of patients with chronic HCV infection will be enrolled. Patients will
be eligible for enrollment if they fulfill the study inclusion and exclusion criteria and
have achieved a complete tumour response (CR) 3 months (+/- 14 days) following HCC treatment
- Cohort A: Patients with Barcelona Clinic Liver Cancer (BCLC) stage 0 or A HCC who have
received curative therapy defined as either; liver transplantation, surgical resection
or local ablation with curative intent and attained a radiologically confirmed CR.
(N=50)
- Cohort B: Patients who are non-eligible for curative therapy but have attained a
radiologically confirmed CR. post embolization or ablative therapy and have chronic HCV
infection. (N=50) Given the existing uncertainty regarding the impact of direct acting
antiviral (DAA) therapy on HCC recurrence, study participants will be randomized to
receive DAA treatment as "immediate" ie upon study enrollment or "delayed" ie treatment
commenced ≥ 6months following documentation of complete response based on radiological
assessment indicating no residual arterial enhancing disease..
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