NCT03490097

Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination

Detailed description

Aim of the work To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through : Primary Outcome: Assessment of therapeutic SVR12 Seconadry Outcome 1\. assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP). 2- Evaluation of CHC related complications such as fibrosis and cirrhosis Patients will be followed up for the whole study period and will be subjected to assessment of the following: 1. CBC , liver function test , lipid profile and CK every month till the end of therapy. 2. HgA1C and CRP at the end of therapy. 3. HCV-PCR test 3 months after the end of therapy. 4. Fibrosis using (FIB-4) 3 months after the end of therapy.

Conditions

• Chronic Hepatitis c
• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Simvastatin 10mg	tablets
DRUG	sofosbuvir plus daclatasvir	sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-05-23
• Completion: 2018-05-23
• First posted: 2018-04-06
• Last updated: 2018-09-20

Locations

1 site across 1 country: Egypt