Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

NCT03490097 | Completed Phase 2

• 1 other identifier: PHCL35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis c; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• SVR 12

  sustained virological response 3 months after the end of therapy

  3 months after end of therapy

Secondary Outcomes (3)

• Lipid marker

  three months

• Glycemic status marker

  three months

• inflammatory marker

  three months

Other Outcomes (1)

• CHC related complications

  6 months

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: Simvastatin 10mg; Drug: sofosbuvir plus daclatasvir

Group II

ACTIVE COMPARATOR

sofosbuvir plus daclatasvir

Drug: sofosbuvir plus daclatasvir

Interventions

Simvastatin 10mg DRUG

tablets

Also known as: simvastatin

Group I

sofosbuvir plus daclatasvir DRUG

sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.

Also known as: Sovodac

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Kobri El koba Armed Forces Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Metabolic Syndrome

Interventions

Simvastatin; Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Nagwa Ali Sabri, Professor

  Professor of clinical pharmacy , ASU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of pharmacy, Ain Shams University

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 6, 2018
• Study Start: December 1, 2017
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

EG (1)