the Pulmonary Safety of Antihepatitis C Treatment

NCT ID: NCT04122066

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2023-12-31

Brief Summary

pulmonary side effects of the new regimen of antihepatitis C

Detailed 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

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

respiratory symptoms reported in studied patients

If Sofosbuvir\\Daclatasvir regimen has respiratory side effects or not and the factors increase incidence of respiratory complications

sofosbuvir \daclatsvir

Intervention Type: DRUG

study the effect of the new oral antihepatitis C drugs on the respiratory system

Interventions

sofosbuvir \daclatsvir

study the effect of the new oral antihepatitis C drugs on the respiratory system

Intervention Type: DRUG

Other Intervention Names

Sovaldi\Daklinza

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marina Omil Saman

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Safaa Mokhtar

Role: STUDY_DIRECTOR

Assiut University

Nahed Makhlouf

Role: STUDY_DIRECTOR

Assiut University

Mostafa kamal

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Marina Saman

Role: CONTACT

marina011335@med.au.edu.eg

01204171412

Other Identifiers

safety of antihepatiis C drugs

Identifier Type: -

Identifier Source: org_study_id