Back to resultsStatins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
Primary Purpose
Chronic Hepatitis c, Metabolic Syndrome
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Simvastatin 10mg
sofosbuvir plus daclatasvir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis c
Eligibility Criteria
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
Sites / Locations
- Kobri El koba Armed Forces Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I
Group II
Arm Description
low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.
sofosbuvir plus daclatasvir
Outcomes
Primary Outcome Measures
SVR 12
sustained virological response 3 months after the end of therapy
Secondary Outcome Measures
Lipid marker
lipid profile
Glycemic status marker
fasting glucose test
inflammatory marker
C-reactive protein(CRP).
Full Information
NCT ID
NCT03490097
First Posted
March 19, 2018
Last Updated
September 19, 2018
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03490097
Brief Title
Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
Official Title
Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis c, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
sofosbuvir plus daclatasvir
Intervention Type
Drug
Intervention Name(s)
Simvastatin 10mg
Other Intervention Name(s)
simvastatin
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
sofosbuvir plus daclatasvir
Other Intervention Name(s)
Sovodac
Intervention Description
sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.
Primary Outcome Measure Information:
Title
SVR 12
Description
sustained virological response 3 months after the end of therapy
Time Frame
3 months after end of therapy
Secondary Outcome Measure Information:
Title
Lipid marker
Description
lipid profile
Time Frame
three months
Title
Glycemic status marker
Description
fasting glucose test
Time Frame
three months
Title
inflammatory marker
Description
C-reactive protein(CRP).
Time Frame
three months
Other Pre-specified Outcome Measures:
Title
CHC related complications
Description
fibrosis and cirrhosis
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa Ali Sabri, Professor
Organizational Affiliation
Professor of clinical pharmacy , ASU
Official's Role
Study Director
Facility Information:
Facility Name
Kobri El koba Armed Forces Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
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