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the Pulmonary Safety of Antihepatitis C Treatment

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04122066
Collaborator
(none)
50
Enrollment
42
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

pulmonary side effects of the new regimen of antihepatitis C

Condition or Disease Intervention/Treatment Phase
  • Drug: sofosbuvir \daclatsvir

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Pulmonary Safety of the New Oral Antihepatitis C Treatment
Anticipated Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
respiratory symptoms reported in studied patients

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the pulmonary side effect of the new anti HCV medication in our population. [3 months]

      find out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )

    Secondary Outcome Measures

    1. the factors that increase the incidence of pulmonary complications [3 months]

      Identification the factors that increase the incidence of pulmonary complications with the new anti HCV medications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Safaa Mokhtar, Assiut University
    • Study Director: Nahed Makhlouf, Assiut University
    • Study Director: Mostafa kamal, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marina Omil Saman, Principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04122066
    Other Study ID Numbers:
    • safety of antihepatiis C drugs
    First Posted:
    Oct 10, 2019
    Last Update Posted:
    Mar 30, 2020
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Hepatitis C
    Sofosbuvir

    Study Results

    No Results Posted as of Mar 30, 2020