Recurrence Rate of Hepatocellular Carcinoma After Treatment of Chronic Hepatits C Patients With Direct Acting Antivirals: Randomized Controlled Phase 3 Trial

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

• Unexpected results were published in 2016 showed increased aggressiveness and rates of HCC recurrence after curative treatment of HCC in HCV patients treated by DAAs achieving SVR. On the other hand, the retrospective analysis of ANRS study, did not observe an increased risk of HCC recurrence after DAAs treatment in patients who underwent curative HCC treatment.

• Assess the recurrence rate of HCC in HCV infected patients with prior history of treated HCC who achieved rCR with and without administration of DAAs and assess the effect of its timing.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Antiviral Agents

Criteria

Inclusion Criteria:

• Age: more than or equal to 18 years old.

• Confirmed HCV viremia by PCR.

• CHILD Pugh "A".

• HCC diagnosed by criteria according to AASLD guidelines.

• HCC patients should have been treated prior to randomization by resection, or ablation and achieving rCR.

Exclusion Criteria:

• Patients below 18 old.

• Patients with advanced liver condition.

• Patients known HBV or HIV infection.

• Prior history of liver transplantation.

• HCC treatment but without rCR before randomization

• Pregnancy and lactation.

• Patients with other malignancies other than HCC.