Status:
UNKNOWN
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir
Lead Sponsor:
MTI University
Conditions:
Hepatitis C
Eligibility:
All Genders
18-75 years
Brief Summary
To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.
Detailed Description
Methodology: Design: Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV. Patients will be recruited from the National Hep...
Eligibility Criteria
Inclusion
- Patients have positive HCV-RNA and taking DAAS to treat it.
- Both sexes will be included
- Age above 18 to 75 years old
- Child Pugh score ( A and B )
Exclusion
- Total serum bilirubin\<3 mg/dl
- Serum albumin \> 2.8 g/dl
- INR≥ 1.7
- Platelet count\< 50000/mm3 IF any of the above criteria is not caused by liver disease, the patient can be included in the study.
- HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
- Extra- hepatic malignancy.
- Pregnancy or inability to use effective contraception.
- Inadequately controlled diabetes mellitus (HbA1c\>9%).
Key Trial Info
Start Date :
February 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 10 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03247296
Start Date
February 28 2017
End Date
November 10 2017
Last Update
August 11 2017
Active Locations (1)
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1
National Hepatology and Tropical Medicine Research Institute
Cairo, Egypt, 11796