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the Pulmonary Safety of Antihepatitis C Treatment

The Pulmonary Safety of the New Oral Antihepatitis C Treatment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04122066
Enrollment
50
Registered
2019-10-10
Start date
2020-06-30
Completion date
2023-12-31
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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

Interventions

DRUGsofosbuvir \daclatsvir

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
the pulmonary side effect of the new anti HCV medication in our population.3 monthsfind out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )

Secondary

MeasureTime frameDescription
the factors that increase the incidence of pulmonary complications3 monthsIdentification the factors that increase the incidence of pulmonary complications with the new anti HCV medications

Contacts

Primary ContactMarina Saman
marina011335@med.au.edu.eg01204171412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026