Clinical trial NCT04122066: the Pulmonary Safety of Antihepatitis C Treatment
Official title: The Pulmonary Safety of the New Oral Antihepatitis C Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients diagnosed as HCV positive and eligible for search criteria.

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

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 .

Primary outcomes:
measure: the pulmonary side effect of the new anti HCV medication in our population.
timeFrame: 3 months
Secondary outcomes:
measure: the factors that increase the incidence of pulmonary complications
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Safaa Mokhtar
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Nahed Makhlouf
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mostafa kamal
role: STUDY_DIRECTOR
References: