Neoplasms

All Conditions

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis C

Hepatitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Diseases

Gastrointestinal Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Communicable Diseases

Blood-Borne Infections

Hepatitis, Viral, Human

Virus Diseases

Flaviviridae Infections

RNA Virus Infections

Anti-Infective Agents

All Drugs and Chemicals

Sofosbuvir

Ribavirin

Antimetabolites

Antiviral Agents

Patients taking Sofosbuvir and Daclatasvir

Patients taking Sofosbuvir,Daclatasvir, and Ribavirin

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

Sofosbuvir 400 mg, Daclatasvir, Ribavirin

Nagwa A Sabri, Professor

Abd El Rahman El Naggar, Professor

Hasan A El Garem, Professor

Aya M Esawy, Assistant Lecturer

Sara M Zaki, Lecturer

May I Mehrez, Fellow

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

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

MTI University

Assistant Lecturer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir	NCT03247296	Hepatitis C	Sofosbuvir 400 ...	18 Years - 75 Years	MTI University
Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir	NCT03247296	Hepatitis C	Sofosbuvir 400 ...	18 Years - 75 Years	MTI University

Spots Global Cancer Trial Database for sofosbuvir 400 mg, daclatasvir, ribavirin