Liver FibrosesPhase 2HBVNCT07145268
Zinc Sulphate in Treatment Fibrosis in HBV Patient Receiving Antiviral Therapy
A Phase 2 study testing Entecavir (ETV) and Zinc (zinc sulphate) in people with Liver Fibroses and HBV (Hepatitis B Virus), run by Tanta University.
Trial summary
This study aims to investigate the possible safety and efficacy of Zinc sulphate as antifibrotic agent in chronic HBV patient receiving antiviral therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibroses, HBV (Hepatitis B Virus)
- What is being tested?
- Entecavir (ETV) and Zinc (zinc sulphate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with fibrosis stage (F2\&F3) post chronic HBV infection receiving standard antiviral therapy.
- Age > 18 and < 65 years.
Who cannot join
- Patients with prior history of liver transplantation.
- Patients with prior history of hepatocellular carcinoma.
- Patients coinfected with HIV or HCV.
- Patients with any malignancies.
- Pregnant and lactating women.
About this study
Official title: Clinical Study to Evaluate the Possible Antifibrotic Effect of Zinc Sulphate in Chronic HBV Patient Receiving Anti Viral Therapy
This study aims to investigate the possible safety and efficacy of Zinc sulphate as antifibrotic agent in chronic HBV patient receiving antiviral therapy.
Read the detailed description
Hepatitis B virus (HBV) is a serious public health problem worldwide and major cause of chronic hepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). It was estimated that approximately 2 billion people have serological evidence of past or present HBV infection. More than 350 million are chronic carriers of HBV. (1)
Chronic hepatitis B describes a spectrum of disease usually characterized by the presence of detectable hepatitis B surface antigen (HBsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and HCC. (1)
Liver fibrosis due to viral or metabolic chronic liver diseases is a major challenge of global health. Correlating with liver disease progression, fibrosis is a key factor for liver disease outcome and risk of HCC. (2)
Removal or elimination of the causative agent such as control or cure of viral infection has shown that liver fibrosis is reversible. There is a huge unmet medical need for anti-fibrotic therapies to prevent liver disease progression and HCC development. (2) Liver fibrosis is the excessive accumulation of extracellular matrix proteins including collagen that occurs in most types of chronic liver diseases. In the case of chronic HBV infection, ongoing liver inflammation and immune-mediated damage led to fibrosis over time. (2) Zinc is an essential trace element required for normal cell growth, development, and differentiation. It is involved in DNA synthesis, RNA transcription, and cell division and activation. It is a critical component in many zinc protein/enzymes, including critical zinc transcription factors. Zinc deficiency/altered metabolism is observed in many types of liver disease, including alcoholic liver disease and viral liver disease. (3) Serum zinc levels are significantly decreased in patients with acute hepatitis B infection and are frequently depressed with HBV cirrhosis (similar to HCV cirrhosis). Specifically designed zinc finger proteins had been used in an attempt to inhibit HBV viral transcription with some success, and this is a potential therapeutic target for new HBV drugs. Importantly, marginal zinc deficiency appears to impair the efficacy of hepatitis B vaccination. This is another example of how zinc deficiency may impair immune function with special relevance to liver disease. (3) Zinc supplementation suppresses the progression of liver fibrosis induced by bile duct ligation in mice. (4) Liver biopsy is recognized as the gold standard for disease monitoring; however, the procedure is invasive and bedeviled with potential complications. For these reasons, non-invasive biomarkers of fibrosis are now being evaluated as alternatives to liver biopsy. (5) Fibronectin is a glycoprotein involved in wound healing and extracellular matrix formation. Elevated levels are associated with liver fibrosis due to increased extracellular matrix deposition. It reflects fibrogenesis activity and can serve as an early indicator of fibrotic progression or regression. (6) Serum hyaluronic acid (HA) level is a precise predictor of extensive liver fibrosis in chronic hepatitis B. Stage of fibrosis is well correlated with HA which can reflect the severity of fibrosis. Thus, it can be used as a noninvasive test to monitor these patients. (7)
- Conditions
- Liver Fibroses, HBV (Hepatitis B Virus)
- Being tested
- Entecavir (ETV), Zinc (zinc sulphate)
- Medical subject headings
- Liver Cirrhosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir (ETV)Drug
Standard antiviral therapy with Entecavir 0.5 mg orally once daily for 6 months."(control group)
Zinc (zinc sulphate)Drug
Zinc sulfate 220 mg orally once daily (50 mg elemental zinc) in addition to Entecavir 0.5 mg, for 6 months."
| Study group | Role | What they receive |
|---|---|---|
| (control group) | Placebo comparator | 22 patients will continue their standard antiviral therapy (Entecavir 0.5 mg) for 6 months. Receives: Drug: Entecavir (ETV) |
| (zinc group) | Active comparator | 22 patients will receive Zinc suIphate 220 mg orally once daily (equivalent to 50 mg elemental zinc), in addition to their standard antiviral therapy (Entecavir 0.5 mg), for 6 months. Receives: Drug: Zinc (zinc sulphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fibrosis scores.
Measured: 6 months
Secondary outcomes (1)
Change in serum biomarkers
The secondary outcome is decrease in serum levels of the measured biological markers which are (fibronectin \& HA)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- More trials run by Tanta 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Mohamed Ragai Elrefaey, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145268
- Sponsor's protocol ID
- zinc sulphate in HBV
- Acronym
- HBV
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Antifibrotic Effect of Zinc Sulphate in Chronic HBV Patient Receiving Anti Viral Therapy
- ClinicalTrials.gov ID
- NCT07145268
- Acronym / sponsor ID
- HBV / zinc sulphate in HBV
- Conditions
- Liver Fibroses, HBV (Hepatitis B Virus)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
This study aims to investigate the possible safety and efficacy of Zinc sulphate as antifibrotic agent in chronic HBV patient receiving antiviral therapy.
Detailed description
Hepatitis B virus (HBV) is a serious public health problem worldwide and major cause of chronic hepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). It was estimated that approximately 2 billion people have serological evidence of past or present HBV infection. More than 350 million are chronic carriers of HBV. (1)
Chronic hepatitis B describes a spectrum of disease usually characterized by the presence of detectable hepatitis B surface antigen (HBsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and HCC. (1)
Liver fibrosis due to viral or metabolic chronic liver diseases is a major challenge of global health. Correlating with liver disease progression, fibrosis is a key factor for liver disease outcome and risk of HCC. (2)
Removal or elimination of the causative agent such as control or cure of viral infection has shown that liver fibrosis is reversible. There is a huge unmet medical need for anti-fibrotic therapies to prevent liver disease progression and HCC development. (2) Liver fibrosis is the excessive accumulation of extracellular matrix proteins including collagen that occurs in most types of chronic liver diseases. In the case of chronic HBV infection, ongoing liver inflammation and immune-mediated damage led to fibrosis over time. (2) Zinc is an essential trace element required for normal cell growth, development, and differentiation. It is involved in DNA synthesis, RNA transcription, and cell division and activation. It is a critical component in many zinc protein/enzymes, including critical zinc transcription factors. Zinc deficiency/altered metabolism is observed in many types of liver disease, including alcoholic liver disease and viral liver disease. (3) Serum zinc levels are significantly decreased in patients with acute hepatitis B infection and are frequently depressed with HBV cirrhosis (similar to HCV cirrhosis). Specifically designed zinc finger proteins had been used in an attempt to inhibit HBV viral transcription with some success, and this is a potential therapeutic target for new HBV drugs. Importantly, marginal zinc deficiency appears to impair the efficacy of hepatitis B vaccination. This is another example of how zinc deficiency may impair immune function with special relevance to liver disease. (3) Zinc supplementation suppresses the progression of liver fibrosis induced by bile duct ligation in mice. (4) Liver biopsy is recognized as the gold standard for disease monitoring; however, the procedure is invasive and bedeviled with potential complications. For these reasons, non-invasive biomarkers of fibrosis are now being evaluated as alternatives to liver biopsy. (5) Fibronectin is a glycoprotein involved in wound healing and extracellular matrix formation. Elevated levels are associated with liver fibrosis due to increased extracellular matrix deposition. It reflects fibrogenesis activity and can serve as an early indicator of fibrotic progression or regression. (6) Serum hyaluronic acid (HA) level is a precise predictor of extensive liver fibrosis in chronic hepatitis B. Stage of fibrosis is well correlated with HA which can reflect the severity of fibrosis. Thus, it can be used as a noninvasive test to monitor these patients. (7)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (control group) | Placebo comparator | Drug: Entecavir (ETV)22 patients will continue their standard antiviral therapy (Entecavir 0.5 mg) for 6 months. |
| (zinc group) | Active comparator | Drug: Zinc (zinc sulphate)22 patients will receive Zinc suIphate 220 mg orally once daily (equivalent to 50 mg elemental zinc), in addition to their standard antiviral therapy (Entecavir 0.5 mg), for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with fibrosis stage (F2\&F3) post chronic HBV infection receiving standard antiviral therapy.
- Age > 18 and < 65 years.
Key exclusion criteria (5 listed)
- Patients with prior history of liver transplantation.
- Patients with prior history of hepatocellular carcinoma.
- Patients coinfected with HIV or HCV.
- Patients with any malignancies.
- Pregnant and lactating women.
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 |
|---|---|---|
| Entecavir (ETV)Standard antiviral therapy with Entecavir 0.5 mg orally once daily for 6 months."(control group) | Drug | (control group) |
| Zinc (zinc sulphate)Zinc sulfate 220 mg orally once daily (50 mg elemental zinc) in addition to Entecavir 0.5 mg, for 6 months." | Drug | (zinc group) |
Primary outcome
Change in fibrosis scores.
Time frame: 6 months
1 secondary outcome
Change in serum biomarkers
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entecavir (ETV) and Zinc (zinc sulphate) in people with Liver Fibroses and HBV (Hepatitis B Virus), run by Tanta 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 2 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in fibrosis scores. (time frame: 6 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 28 Aug 2025.