Drug-Induced Liver InjuryNCT03602703
Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
An observational study of Drug-Induced Liver Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-Induced Liver Injury
- What is being tested?
- Flow cytometry and Western Blot analysis
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Sep 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Cases recruited divided into three groups .Each group either treated or not with DAAs
Who may be able to join
- Patients with HCC on top of HCV related liver cirrhosis either received treatment or not
- Patients without HCC either received treatment or not .
- Patients with chronic HCV as a control group either received treatment or not.
Who cannot join
- Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc
- Patients with recurrent HCC after curative treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)
Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC
Read the detailed description
Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.
Radiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.
Blood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.
Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.
B and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.
Cell cycle analysis and apoptosis will be detected using Annexin V/PI staining method and flow cytometry analysis. The phosphorylation and activation of cytoplasmic proteins will be tested using Western blot analysis.
- Conditions
- Drug-Induced Liver Injury
- Being tested
- Flow cytometry and Western Blot analysis
- Keywords
- Direct acting antiviral drugs immune responses
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometry and Western Blot analysisDiagnostic test
Diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| chronic HCV | chronic HCV either treated or not with DAAs.Flow cytometry and Western Blot analysis for each subgroup Receives: Diagnostic Test: Flow cytometry and Western Blot analysis | |
| Liver cirrhosis without HCC | Liver cirrhosis without HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup Receives: Diagnostic Test: Flow cytometry and Western Blot analysis | |
| Liver cirrhosis with HCC | Liver cirrhosis with HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup Receives: Diagnostic Test: Flow cytometry and Western Blot analysis | |
| Control group | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of immunity in patients with de novo HCC develped after treatment with DAAs
Difference of B and T cells immune responses after treatment with DAAs between those who develop HCC and those who do not develop HCC
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Induced Liver InjuryStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidi Karam, Assiut University
- Investigators
- Haidi Ramadan, Lecturer, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602703
- Sponsor's protocol ID
- 17300211
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Immune Cell Responses in Chronic HCV Patients Developing Hepatocellular Carcinoma After Treatment With Direct Acting Antiviral Drugs (DAAs)
- ClinicalTrials.gov ID
- NCT03602703
- Acronym / sponsor ID
- 17300211
- Conditions
- Drug-Induced Liver Injury
- Keywords
- Direct acting antiviral drugs immune responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 27 Jul 2018 (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.
Case control Study to assess the difference of immune cell responses between patients with chronic HCV- related liver cirrhosis who develop HCC after treatment with DAAs and those who do not develop HCC
Detailed description
Clinical and laboratory assessment with measurement of Child-Pugh and MELD scores to assess the severity of liver disease and measurement of alpha fetoprotein level for HCC cases will be done.
Radiological assessment using abdominal ultrasound and triphasic CT will be done to determine the extent of the HCC and staging.
Blood sample from all patients will be withdrawn. Plasma will be isolated and stored at - 20C and further analysis for a panel of cytokines, caspases and growth factors using ELISA will be monitored.
Peripheral blood mononuclear cells (PBMCs) will be isolated using ficoll gradient method and will then be stored at -80C.
B and T cell proliferation in response to specific antigens will also be investigated using CFSE staining assay followed by flow cytometry analysis for CD4, CD8 and PD-1.
Cell cycle analysis and apoptosis will be detected using Annexin V/PI staining method and flow cytometry analysis. The phosphorylation and activation of cytoplasmic proteins will be tested using Western blot analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chronic HCV | – | Diagnostic Test: Flow cytometry and Western Blot analysischronic HCV either treated or not with DAAs.Flow cytometry and Western Blot analysis for each subgroup |
| Liver cirrhosis without HCC | – | Diagnostic Test: Flow cytometry and Western Blot analysisLiver cirrhosis without HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup |
| Liver cirrhosis with HCC | – | Diagnostic Test: Flow cytometry and Western Blot analysisLiver cirrhosis with HCC either received treatment or not.Flow cytometry and Western Blot analysis for each subgroup |
| Control group | – | –Healthy subjects |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cases recruited divided into three groups .Each group either treated or not with DAAs
Key inclusion criteria (3 listed)
- Patients with HCC on top of HCV related liver cirrhosis either received treatment or not
- Patients without HCC either received treatment or not .
- Patients with chronic HCV as a control group either received treatment or not.
Key exclusion criteria (2 listed)
- Patients with HCC who received any interventional treatment as alcohol injection, radiofrequency , TACE..etc
- Patients with recurrent HCC after curative treatment.
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 |
|---|---|---|
| Flow cytometry and Western Blot analysisDiagnostic tests | Diagnostic test | Liver cirrhosis with HCC, Liver cirrhosis without HCC, chronic HCV |
Primary outcome
Pattern of immunity in patients with de novo HCC develped after treatment with DAAs
Time frame: Two months
Difference of B and T cells immune responses after treatment with DAAs between those who develop HCC and those who do not develop HCC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Haidi Ramadan, Lecturer principal investigator
Lecturer
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 Drug-Induced Liver Injury, run by Assiut 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of immunity in patients with de novo HCC develped after treatment with DAAs (time frame: Two 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 9 Apr 2020.