Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

NCT ID: NCT03490097

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-05-23

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.

Conditions

Chronic Hepatitis c; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I

low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.

Group Type: EXPERIMENTAL

Simvastatin 10mg

Intervention Type: DRUG

tablets

sofosbuvir plus daclatasvir

Intervention Type: DRUG

sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Group II

sofosbuvir plus daclatasvir

Group Type: ACTIVE_COMPARATOR

sofosbuvir plus daclatasvir

Intervention Type: DRUG

sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Interventions

Simvastatin 10mg

tablets

Intervention Type: DRUG

sofosbuvir plus daclatasvir

sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

simvastatin; Sovodac

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mahmoud Shaheen

Associate Professor, Faculty of pharmacy, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa Ali Sabri, Professor

Role: STUDY_DIRECTOR

Professor of clinical pharmacy , ASU

Locations

Kobri El koba Armed Forces Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

PHCL35

Identifier Type: -

Identifier Source: org_study_id