Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Last updated: September 19, 2018
Sponsor: Ain Shams University
Overall Status: Completed

Phase

2/3

Condition

Metabolic Syndrome

Diabetes Prevention

Hepatitis

Treatment

N/A

Clinical Study ID

NCT03490097
PHCL35
  • Ages 18-70
  • Male

Study 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

Eligibility Criteria

Inclusion

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

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 noevidence 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

Study Design

Total Participants: 100
Study Start date:
December 01, 2017
Estimated Completion Date:
May 23, 2018

Study 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.

Connect with a study center

  • Kobri El koba Armed Forces Hospital

    Cairo,
    Egypt

    Site Not Available

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