Clinical trial NCT02771405: Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
Official title: Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Hepatocellular Carcinoma
Keywords: HCV-HCC-DAAs
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Cairo University
First posted: 2016-05-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.

Detailed description: The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .

after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :

1. Sofosbuvir+Ribavirin
2. Sofosbuvir+Simeprevir± Ribavirin
3. Sofosbuvir+ Daclatasvir ± Ribavirin
4. Sofosbuvir+ Ledipasvir ± Ribavirin

the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years old
* Confirmed HCV viremia by PCR
* CHILD Pugh "A" or "B7,B8"
* Confirmed HCC either by laboratory ,imaging or histopathological criteria
* Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A)
* Willing to be treated for HCV and signing informed consent

Exclusion Criteria:

* Patients below 18 or above 70 years old
* patients with advanced liver condition "CHILD score ≥ B9"
* Patients with advanced HCC status (BCLC≥ B)
* Patients with combined HBV ,HIV infection

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
timeFrame: 12 weeks after the last dose of study drugs
Secondary outcomes:
measure: Percentage of participants with virologic failure during treatment or relapse after treatment
timeFrame: from baseline until 12 weeks after the last dose of study drugs
measure: Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC
timeFrame: Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amr Maged
Study officials:
affiliation: Cairo University
name: Gamal Esmat, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Aisha El Sharkawy, MD
role: STUDY_DIRECTOR
affiliation: National Hepatology & Tropical Medicine Research Institute (NHTMRI)
name: Mohamed Hassany, MD
role: STUDY_DIRECTOR
affiliation: National Hepatology & Tropical Medicine Research Institute (NHTMRI)
name: Mai Mehrez, MD.
role: STUDY_DIRECTOR
affiliation: National Hepatology & Tropical Medicine Research Institute (NHTMRI)
name: Amr Maged
role: STUDY_CHAIR
References:
citation: Hassany M, Elsharkawy A, Maged A, Mehrez M, Asem N, Gomaa A, Mostafa Z, Abbas B, Soliman M, Esmat G. Hepatitis C virus treatment by direct-acting antivirals in successfully treated hepatocellular carcinoma and possible mutual impact. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):876-881. doi: 10.1097/MEG.0000000000001152.