Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity and recent estimates showed increase in its prevalence over the last decade to > 185 million infections worldwide. Prevalence HCV infection in Egypt is the highest in the world.Chronic viral hepatitis infection increases liver fibrosis and stiffness and is an important cause of liver cirrhosis. 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 .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections.Interferon (INF) based therapy was used in chronic HCV patient and investigators reported that it's effective in eradicating HCV RNA and improving liver fibrosis. However, It's associated with several side effects.Novel direct antiviral agents (DAA) for chronic hepatitis C have entered clinical practice. This therapeutics has minimal side effects and achieves sustained virological response (SVR) rates of above 90% of patients and they are shorter and simpler regimens.Liver fibrosis severity assessment is important when staging chronic HCV and it reflects impact of serological viral eradication on hepatic damage and fibrosis. Although liver biopsy is the gold standard procedure for fibrosis assessment, but non-invasive new approaches have been strongly recommended for evaluation of fibrosis, mainly in HCV. They have no complications and have good diagnostic accuracy. One of the most used non-invasive mechanical methods based on ultrasound is transient elastography (Fibro Scan). Although association of baseline metabolic characteristics with treatment outcome has not been fully assessed for DAAs, this group was reported to result in improved rates of SVR and to reduce the predictive ability of these factors except for the baseline low density lipoprotein. The highest prevalence of HCV was reported in Egypt, where genotype 4 is responsible for 91% of infections and DAAs represented main line of treatment in most centers.Although the changes in lipid metabolism after treatment with DAAs were reported for other genotypes. It was not fully studied in genotype 4 infected patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03612973
Study type Interventional
Source Assiut University
Contact
Status Completed
Phase N/A
Start date June 1, 2019
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03673696 - The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects Phase 1
Completed NCT02250001 - Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C N/A
Completed NCT03088917 - 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02865369 - Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment N/A
Recruiting NCT02638233 - Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy Phase 4
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02788682 - Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy N/A
Not yet recruiting NCT01949168 - A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV Phase 2
Completed NCT01439776 - Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients Phase 4
Recruiting NCT01360879 - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease N/A
Recruiting NCT01360892 - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography N/A
Terminated NCT00962936 - Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection Phase 1/Phase 2
Completed NCT00968357 - Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed Phase 2
Recruiting NCT01178749 - Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments N/A
Recruiting NCT00575627 - Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels Phase 4
Completed NCT00537407 - A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment Phase 2
Recruiting NCT00370617 - Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance Phase 4
Completed NCT01684787 - Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients Phase 4