Chronic Hepatitis c Clinical Trial
Official title:
Assessment of Changes in Liver Fibrosis and Stiffness, Lipid Profile and Insulin Resistance in Patients With Chronic Hepatitis C Viral Infection Who Received Direct Acting Antiviral Therapy
Verified date | June 2023 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity.Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections
Status | Completed |
Enrollment | 80 |
Est. completion date | September 30, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 ys. - Disease status: patients with chronic hepatitis C infection, based on the presence of anti-HCV and detectable serum HCV-RNA for 6 months or more who had different grades of fibrosis (F) as estimated by fibroscan - Treatment: treatment naïve patients who will receive direct acting antiviral drugs (Sofosbuvir and Daclatasvir ± ribavirin) for 12 weeks - Negative hepatitis B virus surface Ag and HIV antibodies - No history of hepatocellular carcinoma or development of hepatocellular carcinoma during the treatment period - No other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease). Exclusion Criteria: - Diabetic patients. - Patients using lipid lowering agents. - HCV co-infection with hepatitis B virus(HBV) or human immunodeficiency virus(HIV) - Presence of other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease). - Patients with hepatocellular carcinoma |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in liver fibrosis in HCV patients after receiving direct acting antiviral therapy | by using non-invasive measures (fibro scan) before and after end of treatment (12 weeks0 | 1 year | |
Secondary | Effect of HCV treatment by direct acting antiviral therapy on lipid profile of chronic HCV patients | changes in values of total cholesterol, triglycerides, LDL and HDL at the baseline and end of treatment (12 weeks) | 1 year | |
Secondary | Changes and degree of improvement in insulin resistance in HCV patients after receiving direct acting antiviral therapy | measuring fasting insulin and glucose level with calculation of homeostasis model for the assessment of insulin resistance at the baseline and end of treatment (12 weeks) | 1 year |
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