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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03247296
• Other study ID #: 3132010
• Status: Active, not recruiting
• Phase: N/A
• First received: August 9, 2017
• Last updated: August 10, 2017
• Start date: February 28, 2017
• Est. completion date: November 10, 2017

Study information

• Verified date: August 2017
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 10, 2017
• Est. primary completion date: October 31, 2017
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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%).

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis C

Intervention

Drug:
• Sofosbuvir 400 mg, Daclatasvir, Ribavirin
No intervention made this is an observational study to monitor the already existing protocols of the facility

Locations

Country	Name	City	State
Egypt	National Hepatology and Tropical Medicine Research Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC	occurence of HCC	24 weeks