Metabolic Changes in Chronic HCV Patients Receiving DAAS

NCT04211844 | Unknown FDA Drug

• 1 other identifier: 164
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Observational Study to check metabolic changes between two different hepatitis C antiviral medication groups. This study will evaluate the impact of different treatments on Serum lipid changes, fasting blood glucose and glycated hemoglobin . It will determine if changes are due to different Antiviral regimens or due to different Sustained virological response rates.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Change from baseline Total Lipid Profile within 6 months

  serum cholesterol, High density lipoproteins, Low density lipoproteins, Triglycerides, very low density lipoprotein , all measured in mg/dL after 12 hours of fasting

  baseline, week 4 (during treatment), week 24 (after end of treatment)

• Change from baseline Glycosylated Hemoglobin within 6 months

  average level of blood sugar over the past 2 to 3 months, measured in percentage %

  baseline, week 4 (during treatment), week 24 (after end of treatment)

• Change from baseline Fasting Blood Glucose within 6 months

  measured as mg/DL after 8 hours of fasting

  baseline, week 4 (during treatment), week 24 (after end of treatment)

Secondary Outcomes (1)

• Treatment Response

  12 WEEKS after end of therapy

Study Arms (2)

sofosbuvir plus daclatasvir

50 patients receiving 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks. Blood samples are taken at baseline (week 0), week 4 (during treatment) and week 24 (post treatment after discontinuation of treatment at sustained virological response). Samples will be evaluated for lipid profiles, fasting blood sugar and glycated hemoglobin.

Drug: sofosbuvir plus daclatasvir

sofosbuvir plus ledipasvir

50 patients receiving 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks. Blood samples are taken at baseline (week 0), week 4 (during treatment) and week 24 (post treatment after discontinuation of treatment at sustained virological response). Samples will be evaluated for lipid profiles, fasting blood sugar and glycated hemoglobin.

Drug: Sofosbuvir plus Ledipasvir

Interventions

sofosbuvir plus daclatasvir DRUG

50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks.

Also known as: Sovaldi Daklinza

sofosbuvir plus daclatasvir

Sofosbuvir plus Ledipasvir DRUG

50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks.

Also known as: Harvoni

sofosbuvir plus ledipasvir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cases involved in the study will be recruited from El-Demerdash Ain Shams University Hospital in Cairo, Egypt. Patients will be followed up at the "HCV treatment unit Ain Shams University Hospital" for the whole study period.

You may qualify if:

• Male or female patients age 18 to 75 years old. Patients ≥ 65 years old should undergo cardiological assessment prior to therapy by ECG, echocardiography and cardiological consultaion.
• Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
• Clinically stable condition.
• Platelet count ≥ 150,000/mm³.
• INR ≤ 1.2
• Serum albumin ≥ 3.5 g/dl.
• Total serum bilirubin ≤ 1.2 mg/dl.
• eGFR \> 30 ml/min

You may not qualify if:

• Pregnancy or inability to use effective contraceptives.
• Inadequately controlled diabetes mellitus (HbA1c \> 9%)
• HCV-HIV co infection.
• HBV-HCV co infection.
• Any cause for chronic liver disease other than hepatitis C
• Hyper or hypothyroidism.
• Hepatocellular carcinoma, except 6 months 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.
• Fibrosis: FIB-4 index ≥ 3
• Patients prescribed with lipid-lowering agents (statins).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

El Demerdash Hospital

Cairo, Abbasseya, 11588, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Sofosbuvir; daclatasvir; ledipasvir; ledipasvir, sofosbuvir drug combination

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

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Nehal Abdel Fattah, PharmB

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehal Abdel Fattah, PharmB

CONTACT

+201065600196; nehal_gb@hotmail.com

Sara Zaki, PhD

CONTACT

+201008742248; drsara61181@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 26, 2019
• Study Start: October 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

EG (1)