Chronic Hepatitis cNCT05170490
Long Term Follow up of Chronic HCV Patients Receiving DAAS
An observational study of Chronic Hepatitis c, run by Sohag University at 1 site in Egypt.
Trial summary
Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis c
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Mar 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: adult patients with chronic hepatitis C who received direct-acting antiviral drugs and scheived SVR
Who may be able to join
- Chronic HCV patients with moderate to severe hepatic fibrosis (F2: F4) or cirrhosis who received direct-acting antivirals and achieved SVR.
Who cannot join
- Other liver diseases as Chronic hepatitis B and autoimmune liver disease. HIV co-infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Amira Maher, MD, 00201006789652, amiramaher@med.edu.sohag.eg
About this study
Official title: Long Term Follow up of Chronic Hepatitis C Patients Treated With Direct Acting Antivirals After Sustained Virological Response
Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions.
Read the detailed description
Treatment of chronic hepatitis C is evolving rapidly. Three classes of direct-acting antiviral agents, including inhibitors of the HCV NS3/4A protease, NS5B polymerase, and NS5A have been approved for the treatment of patients with chronic hepatitis C, both in combination with pegylated Interferon (Peg-IFN) / ribavirin (RBV) and, recently, in interferon-free combination.
The objective of chronic hepatitis C treatment is to achieve SVR which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. SVR reduces morbidity and mortality and is equivalent in most cases to cure the HCV infection. Studies have demonstrated that SVR is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and HCC.
- Conditions
- Chronic Hepatitis c
- Medical subject headings
- Hepatitis C, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in hepatic fibrosis
Shear wave elastography
Measured: 4 years after end of treatment
Secondary outcomes (3)
change in serum albumin level
change in liver function
Measured: 4 years after end of treatment
change in prothrombin level
change in liver function
Measured: 4 years after end of treatment
change in bilirubin level
change in liver function
Measured: 4 years after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jun 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Maher, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170490
- Sponsor's protocol ID
- DAAS in HCV patients
- Status last verified
- Jun 2022
- First submitted
- 24 Dec 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Chronic Hepatitis C Patients Treated With Direct Acting Antivirals After Sustained Virological Response
- ClinicalTrials.gov ID
- NCT05170490
- Acronym / sponsor ID
- DAAS in HCV patients
- Conditions
- Chronic Hepatitis c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 28 Dec 2021 (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.
Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions.
Detailed description
Treatment of chronic hepatitis C is evolving rapidly. Three classes of direct-acting antiviral agents, including inhibitors of the HCV NS3/4A protease, NS5B polymerase, and NS5A have been approved for the treatment of patients with chronic hepatitis C, both in combination with pegylated Interferon (Peg-IFN) / ribavirin (RBV) and, recently, in interferon-free combination.
The objective of chronic hepatitis C treatment is to achieve SVR which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. SVR reduces morbidity and mortality and is equivalent in most cases to cure the HCV infection. Studies have demonstrated that SVR is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with chronic hepatitis C who received direct-acting antiviral drugs and scheived SVR
Key inclusion criteria (1 listed)
- Chronic HCV patients with moderate to severe hepatic fibrosis (F2: F4) or cirrhosis who received direct-acting antivirals and achieved SVR.
Key exclusion criteria (1 listed)
- Other liver diseases as Chronic hepatitis B and autoimmune liver disease. HIV co-infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in hepatic fibrosis
Time frame: 4 years after end of treatment
Shear wave elastography
3 secondary outcomes
change in serum albumin level
Time frame: 4 years after end of treatment
change in prothrombin level
Time frame: 4 years after end of treatment
change in bilirubin level
Time frame: 4 years after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis c, run by Sohag University at 1 site in Egypt.
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 1 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 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Amira Maher, MD (00201006789652, amiramaher@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in hepatic fibrosis (time frame: 4 years after end of treatment). 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 Jun 2022.