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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT02771405 |
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Date of registration:
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06/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
FRI-STC |
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Scientific title:
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Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02771405 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mohamed Hassany, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Hepatology & Tropical Medicine Research Institute (NHTMRI) |
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Name:
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Mai Mehrez, MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Hepatology & Tropical Medicine Research Institute (NHTMRI) |
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Name:
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Gamal Esmat, MD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine ,Cairo University |
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Name:
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Amr Maged |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Hepatology & Tropical Medicine Research Institute (NHTMRI) |
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Name:
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Aisha El Sharkawy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine ,Cairo University |
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Name:
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Amr Maged |
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Address:
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Telephone:
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Email:
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amrrasheed88@gmail.com |
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Affiliation:
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Name:
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Mohamed Hassany, MD. |
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Address:
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Telephone:
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+2 01128500015 |
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Email:
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mohamadhassany@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis C, Chronic
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: Ledipasvir
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Drug: Ribavirin
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Drug: Sofosbuvir
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Drug: daclatasvir
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Drug: Simeprevir
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Primary Outcome(s)
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
[Time Frame: 12 weeks after the last dose of study drugs]
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Secondary Outcome(s)
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Percentage of participants with virologic failure during treatment or relapse after treatment
[Time Frame: from baseline until 12 weeks after the last dose of study drugs]
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Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC
[Time Frame: Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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