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

NCT03551444 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Administration of DAA-based treatment

* Antiviral therapy and treatment duration (12/24 weeks) will be indicated in each patient according to the viral genotype/subtype and the severity of liver disease, in accordance with the EASL Recommendations on Treatment of Hepatitis C 2016. * HCV-RNA quantification will be assessed by real-time PCR, with a limit of detection (LOD) of15 IU/mL. * During antiviral treatment, follow-up of the Patients will be monthly by clinical and laboratory evaluation. * Virological response to DAA-based treatment will be assessed by quantitative HCV-RNA at the end of treatment (EOT) and at 4 and 12 weeks after the EOT, to confirm sustained virological response (SVR). * SVR12 is defined as undetectable HCV-RNA at week 12 after the EOT. * Virological failures and early discontinuations of therapy due to adverse events will be also registered.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-04-01
Completion
2019-10-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551444 on ClinicalTrials.gov