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Completed

NCT Number: NCT03490097

Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

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

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Key information

About this study

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

  • 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:

  • CBC , liver function test , lipid profile and CK every month till the end of therapy.
  • HgA1C and CRP at the end of therapy.
  • HCV-PCR test 3 months after the end of therapy.
  • Fibrosis using (FIB-4) 3 months after the end of therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Simvastatin 10mg

Drug

tablets

Other names: simvastatin

sofosbuvir plus daclatasvir

Drug

sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Other names: Sovodac

Primary outcomes

  1. SVR 12

    Time frame: 3 months after end of therapy

    sustained virological response 3 months after the end of therapy

Secondary outcomes

  1. Lipid marker

    Time frame: three months

    lipid profile

  2. Glycemic status marker

    Time frame: three months

    fasting glucose test

  3. inflammatory marker

    Time frame: three months

    C-reactive protein(CRP).

Other outcomes

  1. CHC related complications

    Time frame: 6 months

    fibrosis and cirrhosis

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2018
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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