Hepatitis CNCT04122066
the Pulmonary Safety of Antihepatitis C Treatment
An observational study of Hepatitis C, run by Assiut University.
Trial summary
pulmonary side effects of the new regimen of antihepatitis C Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- sofosbuvir \daclatsvir
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients diagnosed as HCV positive and eligible for search criteria.
Who may be able to join
- 1. HCV RNA positivity .
Who cannot join
- 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
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- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Pulmonary Safety of the New Oral Antihepatitis C Treatment
pulmonary side effects of the new regimen of antihepatitis C
Read the 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
- Conditions
- Hepatitis C
- Being tested
- sofosbuvir \daclatsvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir \daclatsvirDrug
Also called Sovaldi\Daklinza
study the effect of the new oral antihepatitis C drugs on the respiratory system
| Study group | Role | What they receive |
|---|---|---|
| respiratory symptoms reported in studied patients | If Sofosbuvir\Daclatasvir regimen has respiratory side effects or not and the factors increase incidence of respiratory complications Receives: Drug: sofosbuvir \daclatsvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 3 months
Secondary outcomes (1)
the factors that increase the incidence of pulmonary complications
Identification the factors that increase the incidence of pulmonary complications with the new anti HCV medications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study startJun 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Omil Saman, Assiut University
- Investigators
- Safaa Mokhtar, Study director, Assiut UniversityNahed Makhlouf, Study director, Assiut UniversityMostafa kamal, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122066
- Sponsor's protocol ID
- safety of antihepatiis C drugs
- Status last verified
- Nov 2019
- First submitted
- 8 Oct 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulmonary Safety of the New Oral Antihepatitis C Treatment
- ClinicalTrials.gov ID
- NCT04122066
- Acronym / sponsor ID
- safety of antihepatiis C drugs
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| respiratory symptoms reported in studied patients | – | Drug: sofosbuvir \daclatsvirIf Sofosbuvir\Daclatasvir regimen has respiratory side effects or not and the factors increase incidence of respiratory complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients diagnosed as HCV positive and eligible for search criteria.
Key inclusion criteria (1 listed)
- 1. HCV RNA positivity .
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sofosbuvir \daclatsvirAlso: Sovaldi\Daklinzastudy the effect of the new oral antihepatitis C drugs on the respiratory system | Drug | respiratory symptoms reported in studied patients |
Primary outcome
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 )
1 secondary outcome
the factors that increase the incidence of pulmonary complications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa Mokhtar study director
Assiut University
Nahed Makhlouf study director
Assiut University
Mostafa kamal study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Saman (01204171412, marina011335@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pulmonary side effect of the new anti HCV medication in our population. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.