Chronic Hepatitis b PatientsNCT05874440
Clinical Efficacy and Safety of Tenofovir Disoproxil Fumarate and Entcavir in Treatment of Chronic Hepatitis B Patients in Upper Egypt
An observational study of Chronic Hepatitis b Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic hepatitis B (CHB) is one of the major causes of chronic liver diseases worldwide. Around 296 million people were living with chronic hepatitis B infection, with 1.5 million new infections each year and more than 820 thousand people die because of hepatitis B virus (HBV) related complications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis b Patients
- What is being tested?
- Tenofovir Disoproxil Fumarate and Entcavir
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2023to 30 Apr 2024
- 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: The study population will consist of individuals who have been diagnosed with CHB and have undergone treatment with either ETV or TDF. These patients will be monitored regularly to evaluate the efficacy and safety of the respective therapies. Patients who meet the inclusion criteria and do not have any of the specified exclusion criteria will be eligible to participate in the study. It is important to note that the study population will exclude individuals who are under 18 years old, those with co-infections of HCV or HDV, as well as patients receiving immune suppressive therapy or with a history of immunodeficiency. By defining the study population based on these criteria, the research can focus on evaluating the outcomes and safety profile of ETV and TDF in a specific group of patients with CHB.
Who may be able to join
- Patient with HbsAg positivity for at least 6 months.
- Patients have HbeAg positive or negative.
- Patient recived Theryapy with ETV 0.5 or 1 mg/day or TDF 300 mg/day.
- Patients have Regular monitoring every 6 months.
Who cannot join
- Patients younger than 18 years old.
- Patients co-infected with hepatitis C, hepatitis D.
- Patients receiving immune suppressive therapy or with history of immunodeficiency
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor, 0934602963, portal@med.sohag.edu.eg
About this study
Chronic hepatitis B (CHB) is one of the major causes of chronic liver diseases worldwide. Around 296 million people were living with chronic hepatitis B infection, with 1.5 million new infections each year and more than 820 thousand people die because of hepatitis B virus (HBV) related complications
Read the detailed description
Chronic Hepatitis B is a long-term liver disease. The disease is often characterized by abnormal levels of serum ALT and AST, as well as liver histology, and is transmitted through blood, sexual contact, and mother-to-child transmission.
The symptoms of CHB include fatigue, nausea, abdominal distension, and Rt hypochondrial pain, and in severe cases, it can be accompanied by chronic liver disease, spider nevus, abnormal liver function, or persistent abnormality. The progression of hepatitis B virus (HBV) is closely linked to its replication, and the most effective way to prevent it is through hepatitis B vaccination. However, there is currently no specific drug available to eliminate the virus in patients with chronic hepatitis B (CHB) due to the low rate of HBsAg clearance. Instead, primary treatment methods for CHB aim to inhibit virus replication for an extended period and delay the onset of liver cirrhosis and hepatocellular carcinoma. Antiviral, liver protection, antifibrosis, and immunomodulatory therapies are used to achieve this goal. Among these therapies, nucleoside (acid) analogs (NA) are commonly used, with drugs such as entecavir (ETV) and tenofovir (TDF) being the most effective. Tenofovir is a new type of nucleotide reverse transcriptase inhibitor, which inhibits reverse transcriptase similarly to nucleoside reverse transcriptase inhibitors. To a certain extent, it can reduce transaminase, protect the liver, and has a good effect on the treatment of hepatitis B. ETV is a carboxylic analog of 2'-deoxyguanosine, which inhibits HBV DNA polymerase by competing with natural deoxy guanosine triphosphate.
The use of entecavir (ETV) and tenofovir disoproxil (TDF) are both effective in managing hepatitis B virus (HBV) infection, and are well-tolerated by most patients.
While there are no significant differences in the ability of the various treatments to suppress the virus, some studies suggest that TDF may achieve biochemical response more quickly. Nucleoside analogs with a high barrier to resistance are unlikely to lead to the clearance of hepatitis B surface antigen, and should therefore be continued for most patients throughout their lifetime. However, there are concerns about the potential for toxicity with TDF in patients who have additional risk factors for kidney and bone problems. It is important to monitor for adverse effects, and switching to ETV may be a safe and effective alternative for patients with HBV. Although effective antiviral treatment can improve the clinical outcome of chronic HBV patients, there is still a risk of developing hepatocellular carcinoma (HCC) even with viral suppression. It is unclear whether TDF-based regimens offer any additional benefits over ETV in preventing HCC, and more research is needed in this area. Studies conducted on both TDF and ETV have demonstrated their safety in both pivotal trials and real-life cohorts. In less than 10% of cases, mild side effects such as headache, fatigue, dizziness, nausea, abdominal discomfort, and nasopharyngitis have been reported for both drugs. These side effects are generally temporary and not severe enough to require discontinuation of treatment. However, TDF has been associated with kidney dysfunction, particularly in patients with pre-existing kidney disease or other risk factors for renal impairment. Furthermore, TDF has been linked to bone disease. As a result, the European Association for the Study of the Liver recommends selecting or switching to ETV for patients with chronic hepatitis B who are at greater risk of bone and kidney toxicity.
- Conditions
- Chronic Hepatitis b Patients
- Being tested
- Tenofovir Disoproxil Fumarate and Entcavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate and EntcavirDrug
Regular registration of side effects of the drugs, cause of non-compliance to treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment-Related Adverse Events as Assessed by CTCAE v4.0Disoproxil Fumarate and Entcavir
This outcome measure aims to evaluate the safety profile of Tenofovir Disoproxil Fumarate (TDF) and Entecavir (ETV) in the treatment of Chronic Hepatitis B (CHB). It will involve assessing and reporting the number of participants who experience adverse events related to the treatment, utilizing the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for assessment
Measured: 12 months
Reduction in Hepatitis B Viral Load with Entecavir (ETV) Treatment as Measured by Quantitative PCR
The primary outcome measure of this study is the reduction in hepatitis B viral load with Entecavir (ETV) treatment, which will be assessed using quantitative polymerase chain reaction (PCR) analysis. The viral load will be quantified by measuring the amount of hepatitis B virus DNA in the patient's blood sample. The collected measurement data will be aggregated to determine the effectiveness of Entecavir (ETV) in reducing viral replication in patients with chronic hepatitis B
Measured: 12 months
Reduction in Hepatitis B Viral Load with Tenofovir Disoproxil Fumarate (TDF) Treatment as Measured by Quantitative PCR
The primary outcome measure of this study is the reduction in hepatitis B viral load with Tenofovir Disoproxil Fumarate (TDF) treatment, which will be assessed using quantitative polymerase chain reaction (PCR) analysis. The viral load will be quantified by measuring the amount of hepatitis B virus DNA in the patient's blood sample. The collected measurement data will be aggregated to determine the effectiveness of Tenofovir Disoproxil Fumarate (TDF) in reducing viral replication in patients with chronic hepatitis B
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 Apr 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis b PatientsStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abdelraof Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874440
- Sponsor's protocol ID
- Soh-Med-23-04-05MD
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi J, Jo C, Lim YS. Tenofovir Versus Entecavir on Recurrence of Hepatitis B Virus-Related Hepatocellular Carcinoma After Surgical Resection. Hepatology. 2021 Feb;73(2):661-673. doi: 10.1002/hep.31289. Epub 2020 Nov 2.
PubMed 32324905Langley DR, Walsh AW, Baldick CJ, Eggers BJ, Rose RE, Levine SM, Kapur AJ, Colonno RJ, Tenney DJ. Inhibition of hepatitis B virus polymerase by entecavir. J Virol. 2007 Apr;81(8):3992-4001. doi: 10.1128/JVI.02395-06. Epub 2007 Jan 31.
PubMed 17267485Lim YS. Management of Antiviral Resistance in Chronic Hepatitis B. Gut Liver. 2017 Mar 15;11(2):189-195. doi: 10.5009/gnl15562.
PubMed 28183162Shi YW, Yang RX, Fan JG. Chronic hepatitis B infection with concomitant hepatic steatosis: Current evidence and opinion. World J Gastroenterol. 2021 Jul 14;27(26):3971-3983. doi: 10.3748/wjg.v27.i26.3971.
PubMed 34326608
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Tenofovir Disoproxil Fumarate and Entcavir in Treatment of Chronic Hepatitis B Patients in Upper Egypt
- ClinicalTrials.gov ID
- NCT05874440
- Acronym / sponsor ID
- Soh-Med-23-04-05MD
- Conditions
- Chronic Hepatitis b Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 24 May 2023 (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.
Chronic hepatitis B (CHB) is one of the major causes of chronic liver diseases worldwide. Around 296 million people were living with chronic hepatitis B infection, with 1.5 million new infections each year and more than 820 thousand people die because of hepatitis B virus (HBV) related complications
Detailed description
Chronic Hepatitis B is a long-term liver disease. The disease is often characterized by abnormal levels of serum ALT and AST, as well as liver histology, and is transmitted through blood, sexual contact, and mother-to-child transmission.
The symptoms of CHB include fatigue, nausea, abdominal distension, and Rt hypochondrial pain, and in severe cases, it can be accompanied by chronic liver disease, spider nevus, abnormal liver function, or persistent abnormality. The progression of hepatitis B virus (HBV) is closely linked to its replication, and the most effective way to prevent it is through hepatitis B vaccination. However, there is currently no specific drug available to eliminate the virus in patients with chronic hepatitis B (CHB) due to the low rate of HBsAg clearance. Instead, primary treatment methods for CHB aim to inhibit virus replication for an extended period and delay the onset of liver cirrhosis and hepatocellular carcinoma. Antiviral, liver protection, antifibrosis, and immunomodulatory therapies are used to achieve this goal. Among these therapies, nucleoside (acid) analogs (NA) are commonly used, with drugs such as entecavir (ETV) and tenofovir (TDF) being the most effective. Tenofovir is a new type of nucleotide reverse transcriptase inhibitor, which inhibits reverse transcriptase similarly to nucleoside reverse transcriptase inhibitors. To a certain extent, it can reduce transaminase, protect the liver, and has a good effect on the treatment of hepatitis B. ETV is a carboxylic analog of 2'-deoxyguanosine, which inhibits HBV DNA polymerase by competing with natural deoxy guanosine triphosphate.
The use of entecavir (ETV) and tenofovir disoproxil (TDF) are both effective in managing hepatitis B virus (HBV) infection, and are well-tolerated by most patients.
While there are no significant differences in the ability of the various treatments to suppress the virus, some studies suggest that TDF may achieve biochemical response more quickly. Nucleoside analogs with a high barrier to resistance are unlikely to lead to the clearance of hepatitis B surface antigen, and should therefore be continued for most patients throughout their lifetime. However, there are concerns about the potential for toxicity with TDF in patients who have additional risk factors for kidney and bone problems. It is important to monitor for adverse effects, and switching to ETV may be a safe and effective alternative for patients with HBV. Although effective antiviral treatment can improve the clinical outcome of chronic HBV patients, there is still a risk of developing hepatocellular carcinoma (HCC) even with viral suppression. It is unclear whether TDF-based regimens offer any additional benefits over ETV in preventing HCC, and more research is needed in this area. Studies conducted on both TDF and ETV have demonstrated their safety in both pivotal trials and real-life cohorts. In less than 10% of cases, mild side effects such as headache, fatigue, dizziness, nausea, abdominal discomfort, and nasopharyngitis have been reported for both drugs. These side effects are generally temporary and not severe enough to require discontinuation of treatment. However, TDF has been associated with kidney dysfunction, particularly in patients with pre-existing kidney disease or other risk factors for renal impairment. Furthermore, TDF has been linked to bone disease. As a result, the European Association for the Study of the Liver recommends selecting or switching to ETV for patients with chronic hepatitis B who are at greater risk of bone and kidney toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who have been diagnosed with CHB and have undergone treatment with either ETV or TDF. These patients will be monitored regularly to evaluate the efficacy and safety of the respective therapies. Patients who meet the inclusion criteria and do not have any of the specified exclusion criteria will be eligible to participate in the study. It is important to note that the study population will exclude individuals who are under 18 years old, those with co-infections of HCV or HDV, as well as patients receiving immune suppressive therapy or with a history of immunodeficiency. By defining the study population based on these criteria, the research can focus on evaluating the outcomes and safety profile of ETV and TDF in a specific group of patients with CHB.
Key inclusion criteria (4 listed)
- Patient with HbsAg positivity for at least 6 months.
- Patients have HbeAg positive or negative.
- Patient recived Theryapy with ETV 0.5 or 1 mg/day or TDF 300 mg/day.
- Patients have Regular monitoring every 6 months.
Key exclusion criteria (3 listed)
- Patients younger than 18 years old.
- Patients co-infected with hepatitis C, hepatitis D.
- Patients receiving immune suppressive therapy or with history of immunodeficiency
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 |
|---|---|---|
| Tenofovir Disoproxil Fumarate and EntcavirRegular registration of side effects of the drugs, cause of non-compliance to treatment | Drug | – |
Primary outcome
Number of Participants Experiencing Treatment-Related Adverse Events as Assessed by CTCAE v4.0Disoproxil Fumarate and Entcavir
Time frame: 12 months
This outcome measure aims to evaluate the safety profile of Tenofovir Disoproxil Fumarate (TDF) and Entecavir (ETV) in the treatment of Chronic Hepatitis B (CHB). It will involve assessing and reporting the number of participants who experience adverse events related to the treatment, utilizing the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for assessment
Reduction in Hepatitis B Viral Load with Entecavir (ETV) Treatment as Measured by Quantitative PCR
Time frame: 12 months
The primary outcome measure of this study is the reduction in hepatitis B viral load with Entecavir (ETV) treatment, which will be assessed using quantitative polymerase chain reaction (PCR) analysis. The viral load will be quantified by measuring the amount of hepatitis B virus DNA in the patient's blood sample. The collected measurement data will be aggregated to determine the effectiveness of Entecavir (ETV) in reducing viral replication in patients with chronic hepatitis B
Reduction in Hepatitis B Viral Load with Tenofovir Disoproxil Fumarate (TDF) Treatment as Measured by Quantitative PCR
Time frame: 12 months
The primary outcome measure of this study is the reduction in hepatitis B viral load with Tenofovir Disoproxil Fumarate (TDF) treatment, which will be assessed using quantitative polymerase chain reaction (PCR) analysis. The viral load will be quantified by measuring the amount of hepatitis B virus DNA in the patient's blood sample. The collected measurement data will be aggregated to determine the effectiveness of Tenofovir Disoproxil Fumarate (TDF) in reducing viral replication in patients with chronic hepatitis B
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 32324905Choi J, Jo C, Lim YS. Tenofovir Versus Entecavir on Recurrence of Hepatitis B Virus-Related Hepatocellular Carcinoma After Surgical Resection. Hepatology. 2021 Feb;73(2):661-673. doi: 10.1002/hep.31289. Epub 2020 Nov 2.
- Background: PubMed 17267485Langley DR, Walsh AW, Baldick CJ, Eggers BJ, Rose RE, Levine SM, Kapur AJ, Colonno RJ, Tenney DJ. Inhibition of hepatitis B virus polymerase by entecavir. J Virol. 2007 Apr;81(8):3992-4001. doi: 10.1128/JVI.02395-06. Epub 2007 Jan 31.
- Background: PubMed 28183162Lim YS. Management of Antiviral Resistance in Chronic Hepatitis B. Gut Liver. 2017 Mar 15;11(2):189-195. doi: 10.5009/gnl15562.
- Background: PubMed 34326608Shi YW, Yang RX, Fan JG. Chronic hepatitis B infection with concomitant hepatic steatosis: Current evidence and opinion. World J Gastroenterol. 2021 Jul 14;27(26):3971-3983. doi: 10.3748/wjg.v27.i26.3971.
- Individual participant dataSharing planned: Undecided
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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 b Patients, 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 4 inclusion and 3 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 24 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Treatment-Related Adverse Events as Assessed by CTCAE v4.0Disoproxil Fumarate and Entcavir (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05874440, which also lists 4 linked publications.
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 24 May 2023.