Clinical trial NCT03247296: Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir
Official title: Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: Daclatasvir
HCC
HCV
Sofosbuvir
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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%).

Primary outcomes:
measure: HCC
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Medicine Research Institute
Study officials:
affiliation: Professor and Head of Clinical Pharmacy Department Faculty of Pharmacy Ain Shams University
name: Nagwa A Sabri, Professor
role: STUDY_CHAIR
affiliation: Professor of clinicalpharmacology and Toxicology and Head of clinical pharmacy Department MTI University
name: Abd El Rahman El Naggar, Professor
role: STUDY_DIRECTOR
affiliation: Prof. Dr. of Endemic Medicine, hepatology, and gastroenterology Faculty of Medicine Cairo University
name: Hasan A El Garem, Professor
role: STUDY_DIRECTOR
affiliation: Assistant Lecturer of clinical pharmacy at faculty of pharmacy MTI university
name: Aya M Esawy, Assistant Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of clinical Pharmacy Faculty of pharmacy Ain-Shams University
name: Sara M Zaki, Lecturer
role: STUDY_DIRECTOR
affiliation: Fellow of Hepatology Internal Medicine Department (NHTMRI)
name: May I Mehrez, Fellow
role: STUDY_DIRECTOR
References: