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

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

Study Overview

• Status: Unknown
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • National Hepatology and Tropical Medicine Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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)

Patients randomly enrolled in the study from the hepatitis clinic in the National Hepatology and Tropical Medicine research Institute

Description

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%).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Patients taking Sofosbuvir and Daclatasvir	Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin; 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	Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin; No intervention made this is an observational study to monitor the already existing protocols of the facility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCC	occurence of HCC	24 weeks

Collaborators and Investigators

• Sponsor: MTI University
• Investigators: Study Chair: Nagwa A Sabri, Professor, Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Ain Shams University; Study Director: Abd El Rahman El Naggar, Professor, Professor of clinicalpharmacology and Toxicology and Head of clinical pharmacy Department MTI University; Study Director: Hasan A El Garem, Professor, Prof. Dr. of Endemic Medicine, hepatology, and gastroenterology Faculty of Medicine Cairo University; Principal Investigator: Aya M Esawy, Assistant Lecturer, Assistant Lecturer of clinical pharmacy at faculty of pharmacy MTI university; Study Director: Sara M Zaki, Lecturer, Lecturer of clinical Pharmacy Faculty of pharmacy Ain-Shams University; Study Director: May I Mehrez, Fellow, Fellow of Hepatology Internal Medicine Department (NHTMRI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2017
• Primary Completion (ANTICIPATED): October 31, 2017
• Study Completion (ANTICIPATED): November 10, 2017

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (ACTUAL): August 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: HCC; HCV; Sofosbuvir; Daclatasvir
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Liver Neoplasms; Hepatitis; Carcinoma, Hepatocellular; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Sofosbuvir; Ribavirin
• Other Study ID Numbers: 3132010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No