Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Phase 2

Completed

• Conditions: Chronic Hepatitis c; Metabolic Syndrome
• Interventions: Drug: sofosbuvir plus daclatasvir; Drug: Simvastatin 10mg

• Registration Number: NCT03490097
• Lead Sponsor: Ain Shams University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-30
• Study First Posted: 2018-04-06
• Primary Completion: 2018-05-23
• Study Completion: 2018-05-23
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-19
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Male patients age 18 to 70 years old.
2. Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
3. Clinically stable condition outpatients.
4. Platelet count ≥ 150,000/mm³.
5. INR ≤ 1.2.
6. Serum albumin ≥ 3.5 g/dl.
7. Total serum bilirubin ≤ 1.2 mg/dl.

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Exclusion Criteria

1. Inadequately controlled diabetes mellitus (HbA1c > 9%) .
2. Total serum bilirubin > 3mg/dl.
3. HCV-HIV co infection.
4. HBV-HCV co infection.
5. Any cause for chronic liver disease other than hepatitis C
6. Uncontrolled hypothyroidism.
7. Hepatocellular carcinoma, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
8. Extra-hepatic malignancy except after two years of disease-free interval.
9. Child's C cirrhotic patients.
10. Creatinine kinase > 350 u/l

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	sofosbuvir plus daclatasvir	sofosbuvir plus daclatasvir
Group I	Simvastatin 10mg	low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.
Group I	sofosbuvir plus daclatasvir	low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
SVR 12	3 months after end of therapy	sustained virological response 3 months after the end of therapy

Secondary Outcome Measures

Name	Time	Method
Lipid marker	three months	lipid profile
Glycemic status marker	three months	fasting glucose test
inflammatory marker	three months	C-reactive protein(CRP).

Trial Locations

Locations (1)

Kobri El koba Armed Forces Hospital; 🇪🇬 Cairo, Egypt