the Pulmonary Safety of Antihepatitis C Treatment

Hepatitis C Clinical Trial

Official title:

The Pulmonary Safety of the New Oral Antihepatitis C Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04122066
• Other study ID #: safety of antihepatiis C drugs
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: December 2023

Study information

• Verified date: November 2019
• Source: Assiut University
• Contact: Marina Saman
• Phone: 01204171412
• Email: marina011335[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

pulmonary side effects of the new regimen of antihepatitis C

Description:

Hepatitis C is a liver disease caused by the hepatitis C virus.The hepatitis C virus is a blood borne virus The most common modes of infection are through exposure to small quantities of blood, through injection drug use, unsafe injection practices, unsafe health care, and the transfusion of unscreened blood and blood products.

An estimated 71 million people have chronic hepatitis C infection. A significant number of those who are chronically infected will develop cirrhosis and or liver cancer. the treatment of hepatitis C virus (HCV) infection has been difficult, particularly in patients with HCV genotype 1. Reasons for the difficulty include the inherent toxicity and limited efficacy of interferon-based therapy, which has been the cornerstone of anti-HCV efforts during the past 2 decades.

Newly available direct-acting antiviral agents (DAAs) have the potential to dramatically improve HCV eradication rates. Despite these new drugs has been characterized by a very low adverse events rate in the published clinical trials Few data are available on pulmonary adverse events based real life studies

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. HCV RNA positivity .

Exclusion Criteria:

• Child C cirrhosis.

• Clinically manifest liver decompensation :ascites ,encephalopathy, wasting, hepatorenal syndrome.

• Serum albumin less than 2.8 g/dl,total serum bilirubin more than 3 mg/dl ,INR1.7 or more .

• absolute neutrophil counts < 1500\mm3 and\or platelet less than 50,000/mm3.

• HCC except 6 months after concluding intervention aiming at cure with no evidence of activity by dynamic CT or MRI.

• Extrahepatic malignancy except after two years of disease\disease free interval

• In lymphomas and chronic lymphatic leukemia can be initiated immediately after remission based on the treating oncologist's report

• Pregnancy or inability to use effective contraception

• Inadequately controlled diabetes mellitus (HbA1c>9%)

• sever renal impairment in which creatinine clearance < 30 ml\min

• chronic lung diseases .

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• sofosbuvir \daclatsvir
study the effect of the new oral antihepatitis C drugs on the respiratory system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the pulmonary side effect of the new anti HCV medication in our population.	find out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )	3 months
Secondary	the factors that increase the incidence of pulmonary complications	Identification the factors that increase the incidence of pulmonary complications with the new anti HCV medications	3 months