Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir
1 other identifier
observational
200
1 country
1
Brief Summary
To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2017
CompletedFirst Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2017
CompletedAugust 11, 2017
August 1, 2017
8 months
August 9, 2017
August 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HCC
occurence of HCC
24 weeks
Study Arms (2)
Group A
Patients taking Sofosbuvir and Daclatasvir
Group B
Patients taking Sofosbuvir,Daclatasvir, and Ribavirin
Interventions
No intervention made this is an observational study to monitor the already existing protocols of the facility
Eligibility 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) Patients randomly enrolled in the study from the hepatitis clinic in the National Hepatology and Tropical Medicine research Institute
You may qualify if:
- 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 )
You may not qualify if:
- 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%).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MTI Universitylead
Study Sites (1)
National Hepatology and Tropical Medicine Research Institute
Cairo, 11796, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 11, 2017
Study Start
February 28, 2017
Primary Completion
October 31, 2017
Study Completion
November 10, 2017
Last Updated
August 11, 2017
Record last verified: 2017-08