Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490097
• Other study ID #: PHCL35
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2017
• Est. completion date: May 23, 2018

Study information

• Verified date: September 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Simvastatin 10mg
tablets
• sofosbuvir plus daclatasvir
sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Locations

Country	Name	City	State
Egypt	Kobri El koba Armed Forces Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CHC related complications	fibrosis and cirrhosis	6 months
Primary	SVR 12	sustained virological response 3 months after the end of therapy	3 months after end of therapy
Secondary	Lipid marker	lipid profile	three months
Secondary	Glycemic status marker	fasting glucose test	three months
Secondary	inflammatory marker	C-reactive protein(CRP).	three months