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

NCT ID: NCT03247296

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2017-11-10

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Patients taking Sofosbuvir and Daclatasvir

Sofosbuvir 400 mg, Daclatasvir, Ribavirin

Intervention Type: DRUG

No intervention made this is an observational study to monitor the already existing protocols of the facility

Group B

Patients taking Sofosbuvir,Daclatasvir, and Ribavirin

Sofosbuvir 400 mg, Daclatasvir, Ribavirin

Intervention Type: DRUG

No intervention made this is an observational study to monitor the already existing protocols of the facility

Interventions

Sofosbuvir 400 mg, Daclatasvir, Ribavirin

No intervention made this is an observational study to monitor the already existing protocols of the facility

Intervention Type: DRUG

Eligibility Criteria

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%).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

Aya Mohammed Mohammed Essawy

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa A Sabri, Professor

Role: STUDY_CHAIR

Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Ain Shams University

Abd El Rahman El Naggar, Professor

Role: STUDY_DIRECTOR

Professor of clinicalpharmacology and Toxicology and Head of clinical pharmacy Department MTI University

Hasan A El Garem, Professor

Role: STUDY_DIRECTOR

Prof. Dr. of Endemic Medicine, hepatology, and gastroenterology Faculty of Medicine Cairo University

Aya M Esawy, Assistant Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assistant Lecturer of clinical pharmacy at faculty of pharmacy MTI university

Sara M Zaki, Lecturer

Role: STUDY_DIRECTOR

Lecturer of clinical Pharmacy Faculty of pharmacy Ain-Shams University

May I Mehrez, Fellow

Role: STUDY_DIRECTOR

Fellow of Hepatology Internal Medicine Department (NHTMRI)

Locations

National Hepatology and Tropical Medicine Research Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

3132010

Identifier Type: -

Identifier Source: org_study_id