Chronic Hepatitis cNCT03612973
Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy
A study testing lipid profile, fasting insulin and fibro scan in people with Chronic Hepatitis c, run by Assiut University at 1 site in Egypt.
Trial summary
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity.Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- lipid profile, fasting insulin and fibro scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 30 Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 ys.
- Disease status: patients with chronic hepatitis C infection, based on the presence of anti-HCV and detectable serum HCV-RNA for 6 months or more who had different grades of fibrosis (F) as estimated by fibroscan
- Treatment: treatment naïve patients who will receive direct acting antiviral drugs (Sofosbuvir and Daclatasvir ± ribavirin) for 12 weeks
- Negative hepatitis B virus surface Ag and HIV antibodies
- No history of hepatocellular carcinoma or development of hepatocellular carcinoma during the treatment period
- No other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease).
Who cannot join
- Diabetic patients.
- Patients using lipid lowering agents.
- HCV co-infection with hepatitis B virus(HBV) or human immunodeficiency virus(HIV)
- Presence of other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease).
- Patients with hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Changes in Liver Fibrosis and Stiffness, Lipid Profile and Insulin Resistance in Patients With Chronic Hepatitis C Viral Infection Who Received Direct Acting Antiviral Therapy
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity.Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections
Read the detailed description
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity and recent estimates showed increase in its prevalence over the last decade to > 185 million infections worldwide. Prevalence HCV infection in Egypt is the highest in the world.Chronic viral hepatitis infection increases liver fibrosis and stiffness and is an important cause of liver cirrhosis. Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections.Interferon (INF) based therapy was used in chronic HCV patient and investigators reported that it's effective in eradicating HCV RNA and improving liver fibrosis. However, It's associated with several side effects.Novel direct antiviral agents (DAA) for chronic hepatitis C have entered clinical practice. This therapeutics has minimal side effects and achieves sustained virological response (SVR) rates of above 90% of patients and they are shorter and simpler regimens.Liver fibrosis severity assessment is important when staging chronic HCV and it reflects impact of serological viral eradication on hepatic damage and fibrosis. Although liver biopsy is the gold standard procedure for fibrosis assessment, but non-invasive new approaches have been strongly recommended for evaluation of fibrosis, mainly in HCV. They have no complications and have good diagnostic accuracy. One of the most used non-invasive mechanical methods based on ultrasound is transient elastography (Fibro Scan). Although association of baseline metabolic characteristics with treatment outcome has not been fully assessed for DAAs, this group was reported to result in improved rates of SVR and to reduce the predictive ability of these factors except for the baseline low density lipoprotein. The highest prevalence of HCV was reported in Egypt, where genotype 4 is responsible for 91% of infections and DAAs represented main line of treatment in most centers.Although the changes in lipid metabolism after treatment with DAAs were reported for other genotypes. It was not fully studied in genotype 4 infected patients.
- Conditions
- Chronic Hepatitis c
- Being tested
- lipid profile, fasting insulin, fibro scan
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid profileDiagnostic test
Serum samples will be withdrawn after fasting 12 hours then performed on Siemens Dimension Max: Total cholesterol and triglyceride concentrations will be estimated using enzymatic methods ( Roche Diagnostics, Mannheim, Germany). High density lipoprotein cholesterol will be determined after precipitation with phosphotungstic acid/magnesium chloride. Low density lipoprotein(LDL) cholesterol will be measured directly with a commercially available direct LDL-C assay (LDL-C Plus assay; Roche Diagnostics)
fasting insulinDiagnostic test
serum samples used for doing the test by ELISA after fasting for 8 h
fibro scanDiagnostic test
liver stiffness by fibro scan before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| non cirrhotic HCV patients | Active comparator | * complete blood picture
* Liver and renal function tests
* Prothrombin time and concentration
* HCV quantitative polymerase chain reaction
* Hepatitis B surface Ag
* lipid profile
* fasting blood glucose level
* fasting insulin level
* homeostasis model for the assessment of insulin resistance (HOMA-IR)
* fibrosis (FIB- 4) index
* Aspartate aminotransferase (AST)/platelet ratio index (APRI)
* Abdominal ultrasound to assess liver and spleen
* Fibroscan/transient elastography to grade hepatic fibrosis all these investigations will be done before and after receiving direct acting antiviral therapy (sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily) for 12 weeks Receives: Diagnostic Test: lipid profile; Diagnostic Test: fasting insulin; Diagnostic Test: fibro scan |
| cirrhotic HCV patients | Active comparator | * complete blood picture
* Liver and renal function tests
* Prothrombin time and concentration
* HCV quantitative polymerase chain reaction
* Hepatitis B surface Ag
* lipid profile
* fasting blood glucose level
* fasting insulin level
* homeostasis model for the assessment of insulin resistance (HOMA-IR)
* Fibrosis (FIB- 4) index
* Aspartate aminotransferase (AST)/platelet ratio index (APRI)
* Abdominal ultrasound to assess liver and spleen
* Fibroscan/transient elastography to grade hepatic fibrosis all these investigations will be done before and after receiving direct acting antiviral therapy (sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily) for 12 weeks Receives: Diagnostic Test: lipid profile; Diagnostic Test: fasting insulin; Diagnostic Test: fibro scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver fibrosis in HCV patients after receiving direct acting antiviral therapy
by using non-invasive measures (fibro scan) before and after end of treatment (12 weeks0
Measured: 1 year
Secondary outcomes (2)
Effect of HCV treatment by direct acting antiviral therapy on lipid profile of chronic HCV patients
changes in values of total cholesterol, triglycerides, LDL and HDL at the baseline and end of treatment (12 weeks)
Measured: 1 year
Changes and degree of improvement in insulin resistance in HCV patients after receiving direct acting antiviral therapy
measuring fasting insulin and glucose level with calculation of homeostasis model for the assessment of insulin resistance at the baseline and end of treatment (12 weeks)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Jun 2019
- Primary completion31 May 2022
- Study completion30 Sep 2022
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- both study groups will be investigated at same time
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa hanafy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612973
- Sponsor's protocol ID
- assuit 1234
- Status last verified
- Jun 2023
- First submitted
- 23 Jul 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Liver Fibrosis and Stiffness, Lipid Profile and Insulin Resistance in Patients With Chronic Hepatitis C Viral Infection Who Received Direct Acting Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03612973
- Acronym / sponsor ID
- assuit 1234
- Conditions
- Chronic Hepatitis c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Aug 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.
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity.Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections
Detailed description
Hepatitis C virus (HCV) is one of the major globally cause of death and morbidity and recent estimates showed increase in its prevalence over the last decade to > 185 million infections worldwide. Prevalence HCV infection in Egypt is the highest in the world.Chronic viral hepatitis infection increases liver fibrosis and stiffness and is an important cause of liver cirrhosis. Chronic hepatitis C is the leading cause of end-stage liver disease, hepatocellular carcinoma and liver-related death in Egypt.It could be considered a special type of metabolic diseases involving insulin resistance (IR) which accelerates fibrosis and modulation of lipid-cholesterol biosynthesis with increased risk for ischemic heart diseases .Increased prevalence of IR and type 2 diabetes mellitus extensively reported in HCV infections.Interferon (INF) based therapy was used in chronic HCV patient and investigators reported that it's effective in eradicating HCV RNA and improving liver fibrosis. However, It's associated with several side effects.Novel direct antiviral agents (DAA) for chronic hepatitis C have entered clinical practice. This therapeutics has minimal side effects and achieves sustained virological response (SVR) rates of above 90% of patients and they are shorter and simpler regimens.Liver fibrosis severity assessment is important when staging chronic HCV and it reflects impact of serological viral eradication on hepatic damage and fibrosis. Although liver biopsy is the gold standard procedure for fibrosis assessment, but non-invasive new approaches have been strongly recommended for evaluation of fibrosis, mainly in HCV. They have no complications and have good diagnostic accuracy. One of the most used non-invasive mechanical methods based on ultrasound is transient elastography (Fibro Scan). Although association of baseline metabolic characteristics with treatment outcome has not been fully assessed for DAAs, this group was reported to result in improved rates of SVR and to reduce the predictive ability of these factors except for the baseline low density lipoprotein. The highest prevalence of HCV was reported in Egypt, where genotype 4 is responsible for 91% of infections and DAAs represented main line of treatment in most centers.Although the changes in lipid metabolism after treatment with DAAs were reported for other genotypes. It was not fully studied in genotype 4 infected patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- both study groups will be investigated at same time
| Arm | Type | Receives |
|---|---|---|
| non cirrhotic HCV patients | Active comparator | Diagnostic Test: lipid profile, Diagnostic Test: fasting insulin, Diagnostic Test: fibro scan* complete blood picture * Liver and renal function tests * Prothrombin time and concentration * HCV quantitative polymerase chain reaction * Hepatitis B surface Ag * lipid profile * fasting blood glucose level * fasting insulin level * homeostasis model for the assessment of insulin resistance (HOMA-IR) * fibrosis (FIB- 4) index * Aspartate aminotransferase (AST)/platelet ratio index (APRI) * Abdominal ultrasound to assess liver and spleen * Fibroscan/transient elastography to grade hepatic fibrosis all these investigations will be done before and after receiving direct acting antiviral therapy (sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily) for 12 weeks |
| cirrhotic HCV patients | Active comparator | Diagnostic Test: lipid profile, Diagnostic Test: fasting insulin, Diagnostic Test: fibro scan* complete blood picture * Liver and renal function tests * Prothrombin time and concentration * HCV quantitative polymerase chain reaction * Hepatitis B surface Ag * lipid profile * fasting blood glucose level * fasting insulin level * homeostasis model for the assessment of insulin resistance (HOMA-IR) * Fibrosis (FIB- 4) index * Aspartate aminotransferase (AST)/platelet ratio index (APRI) * Abdominal ultrasound to assess liver and spleen * Fibroscan/transient elastography to grade hepatic fibrosis all these investigations will be done before and after receiving direct acting antiviral therapy (sofosbuvir 400 mg once daily + daclatasvir 60 mg once daily) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 ys.
- Disease status: patients with chronic hepatitis C infection, based on the presence of anti-HCV and detectable serum HCV-RNA for 6 months or more who had different grades of fibrosis (F) as estimated by fibroscan
- Treatment: treatment naïve patients who will receive direct acting antiviral drugs (Sofosbuvir and Daclatasvir ± ribavirin) for 12 weeks
- Negative hepatitis B virus surface Ag and HIV antibodies
- No history of hepatocellular carcinoma or development of hepatocellular carcinoma during the treatment period
Key exclusion criteria (5 listed)
- Diabetic patients.
- Patients using lipid lowering agents.
- HCV co-infection with hepatitis B virus(HBV) or human immunodeficiency virus(HIV)
- Presence of other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease).
- Patients with hepatocellular carcinoma
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 |
|---|---|---|
| lipid profileSerum samples will be withdrawn after fasting 12 hours then performed on Siemens Dimension Max: Total cholesterol and triglyceride concentrations will be estimated using enzymatic methods ( Roche Diagnostics, Mannheim, Germany). High density lipoprotein cholesterol will be determined after precipitation with phosphotungstic acid/magnesium chloride. Low density lipoprotein(LDL) cholesterol will be measured directly with a commercially available direct LDL-C assay (LDL-C Plus assay; Roche Diagnostics) | Diagnostic test | cirrhotic HCV patients, non cirrhotic HCV patients |
| fasting insulinserum samples used for doing the test by ELISA after fasting for 8 h | Diagnostic test | cirrhotic HCV patients, non cirrhotic HCV patients |
| fibro scanliver stiffness by fibro scan before and after treatment | Diagnostic test | cirrhotic HCV patients, non cirrhotic HCV patients |
Primary outcome
Changes in liver fibrosis in HCV patients after receiving direct acting antiviral therapy
Time frame: 1 year
by using non-invasive measures (fibro scan) before and after end of treatment (12 weeks0
2 secondary outcomes
Effect of HCV treatment by direct acting antiviral therapy on lipid profile of chronic HCV patients
Time frame: 1 year
Changes and degree of improvement in insulin resistance in HCV patients after receiving direct acting antiviral therapy
Time frame: 1 year
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 15 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipid profile, fasting insulin and fibro scan in people with Chronic Hepatitis c, 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 6 inclusion and 5 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 15 Jun 2023. 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?
Changes in liver fibrosis in HCV patients after receiving direct acting antiviral therapy (time frame: 1 year). 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 15 Jun 2023.