the Pulmonary Safety of Antihepatitis C Treatment

March 26, 2020 updated by: Marina Omil Saman, Assiut University

The Pulmonary Safety of the New Oral Antihepatitis C Treatment

pulmonary side effects of the new regimen of antihepatitis C

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

50 patients diagnosed as HCV positive and eligible for search criteria.

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the pulmonary side effect of the new anti HCV medication in our population.
Time Frame: 3 months
find out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the factors that increase the incidence of pulmonary complications
Time Frame: 3 months
Identification the factors that increase the incidence of pulmonary complications with the new anti HCV medications
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Nahed Makhlouf, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • safety of antihepatiis C drugs

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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