Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
NCT ID: NCT02771405
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2016-03-31
2019-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sofosbuvir +Ribavirin
Sofosbuvir 400 mg/day +ribavirin for 24 weeks
Sofosbuvir
Sofosbuvir 400 mg orally once daily
Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Sofosbuvir+Simeprevir±Ribavirin
Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Sofosbuvir
Sofosbuvir 400 mg orally once daily
Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Simeprevir
Simeprevir 150 mg orally once daily
Sofosbuvir+Daclatasvir±Ribavirin
Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Sofosbuvir
Sofosbuvir 400 mg orally once daily
Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
daclatasvir
Daclatasvir 60 mg orally once daily
Sofosbuvir+Ledipasvir±Ribavirin
Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
Sofosbuvir
Sofosbuvir 400 mg orally once daily
Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Ledipasvir
Ledipasvir 90 mg orally once daily
Interventions
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Sofosbuvir
Sofosbuvir 400 mg orally once daily
Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Simeprevir
Simeprevir 150 mg orally once daily
daclatasvir
Daclatasvir 60 mg orally once daily
Ledipasvir
Ledipasvir 90 mg orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with advanced liver condition "CHILD score ≥ B9"
* Patients with advanced HCC status (BCLC≥ B)
* Patients with combined HBV ,HIV infection
18 Years
70 Years
ALL
No
Sponsors
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Cairo University
OTHER
National Hepatology & Tropical Medicine Research Institute
OTHER_GOV
Responsible Party
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Mohamed Hassany
Hepatology & Gastroenterology Consultant , Director of HCC Unit
Principal Investigators
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Gamal Esmat, MD.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Aisha El Sharkawy, MD
Role: STUDY_DIRECTOR
Cairo University
Mohamed Hassany, MD
Role: STUDY_DIRECTOR
National Hepatology & Tropical Medicine Research Institute (NHTMRI)
Mai Mehrez, MD.
Role: STUDY_DIRECTOR
National Hepatology & Tropical Medicine Research Institute (NHTMRI)
Amr Maged
Role: STUDY_CHAIR
National Hepatology & Tropical Medicine Research Institute (NHTMRI)
Locations
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Amr Maged
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Study Documents
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Document Type: Informed Consent Form
View DocumentOther Identifiers
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4/2016
Identifier Type: -
Identifier Source: org_study_id
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