the Pulmonary Safety of Antihepatitis C Treatment

NCT04122066 | Unknown FDA Drug

• 1 other identifier: safety of antihepatiis C drugs
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

pulmonary side effects of the new regimen of antihepatitis C

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• the pulmonary side effect of the new anti HCV medication in our population.

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

  3 months

Secondary Outcomes (1)

• the factors that increase the incidence of pulmonary complications

  3 months

Study Arms (1)

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

Interventions

sofosbuvir \daclatsvir DRUG

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

Also known as: Sovaldi\Daklinza

respiratory symptoms reported in studied patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. HCV RNA positivity .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Safaa Mokhtar

  Assiut University

  STUDY DIRECTOR

• Nahed Makhlouf

  Assiut University

  STUDY DIRECTOR

• Mostafa kamal

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Marina Saman

CONTACT

01204171412; marina011335@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: June 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 30, 2020

Record last verified: 2019-11