NCT03247296

Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: MTI University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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 Hepatology and Tropical Medicine Research Institute (NHTMRI) Duration of study: 24 weeks from starting the DAAs Methods: Patients will go through examination and lab. Workup three times in this study: * FIRST time: * Before starting antiviral therapy, all included patients will undergo through physical examination, lab workup including HCV-RNA quantitative, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in child bearing period), AFP as a marker of HCC. * Included patients will also undergo through diagnostic procedures as Abdominal ultrasonography and ECG (men \>40, women\>50). * Second time: * At the end of antiviral therapy (12 weeks), virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR. * Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC. * The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC. * Third and last time: * At 24 weeks ( Patients will be off treatment for the previous 12 weeks) , virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR. * Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC. * The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir 400 mg, Daclatasvir, Ribavirin	No intervention made this is an observational study to monitor the already existing protocols of the facility

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-10-31
• Completion: 2017-11-10
• First posted: 2017-08-11
• Last updated: 2017-08-11

Locations

1 site across 1 country: Egypt