Hepatitis B Virus InfectionPhase 4FlavonoidsNCT07084948
Inhibition of HBV Replication and Biological Reversal of Cirrhosis (F3-F4) and HCC by Flavonoids
A Phase 4 study testing Flavonoid and Tenofovir in people with Hepatitis B Virus Infection, run by Trieu, Nguyen Thi, M.D. at 2 sites in 2 countries.
Trial summary
SB Flavonoids for Advanced Liver Disease ManagementSB Flavonoids represents a multi-target therapeutic composition engineered for the comprehensive management of Hepatitis (Acute and Chronic), Advanced Cirrhosis (F3)-(F4), and Early-stage Hepatocellular Carcinoma (HCC).The formulation features a synergistic complex of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis B Virus Infection
- What is being tested?
- Flavonoid and Tenofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Nov 2015to 20 Apr 2026
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with underlying medical conditions who have been taking medications for these conditions.
- Patients with AIDS, HIV, HBV, HCV, and patients with co-infections.
- The cancer patients are stable.
- Patients with congenital or acquired immunodeficiency.
Who cannot join
- Unstable cancer patients.
- Decompensated cirrhosis.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Saigon Biopharma LLC
Wilmington, Delaware, 19801-6601
Vietnam1 site
Saigon Biopharma Company Limited
Hồ Chí Minh, Ho Chi Minh City, 700000
About this study
Official title: Therapeutic Efficacy of SB Flavon in the Treatment of Advanced (F3-F4) HBV-related Cirrhosis and Hepatocellular Carcinoma
SB Flavonoids for Advanced Liver Disease ManagementSB Flavonoids represents a multi-target therapeutic composition engineered for the comprehensive management of Hepatitis (Acute and Chronic), Advanced Cirrhosis (F3)-(F4), and Early-stage Hepatocellular Carcinoma (HCC).The formulation features a synergistic complex of Ascorbic Acid, L-Arginine Hydrochloride, and a high-potency flavonoid blend, including Kaempferol, Urinariaflavone, Quercetin, Rutin, and 5,6-dihydroxy-7,8,4'-trimethoxy-flavone. This combination exerts a powerful hepatoprotective and antifibrotic effect by:
Structural Regeneration: Promoting the repair and regeneration of functional liver parenchyma while stabilizing hepatocyte membranes to mitigate oxidative stress.
Read more
Bioreversal of Fibrosis: Actively inhibiting the activation of pro-fibrogenic cells (hepatic stellate cells) and remodeling the extracellular matrix to reverse advanced (F3)-(F4) fibrosis.
Oncogenic Suppression: Inhibiting the proliferation of malignant cells to prevent the progression of early-stage liver cancer.
Homeostatic Restoration: Providing essential molecular precursors to strengthen the host's immune surveillance, reduce chronic inflammation, and restore the liver's physiological and biochemical homeostasis.By addressing both viral-induced damage and structural degradation, SB Flavonoids offers a novel pathway for restoring hepatic function and systemic health in patients with progressive liver diseases.
Read the detailed description
Therapeutic Composition and Mechanism of Action. The core of this pharmaceutical composition is a synergistic complex of Ascorbic Acid, L-Arginine Hydrochloride, and a high-potency flavonoid blend (Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, and Rutin). These compounds function as pivotal agents in the protection of hepatocyte membranes, mitigation of oxidative stress, and preservation of the liver's structural integrity.
Structural Regeneration and Fibrosis Reversal. The selected flavonoids specifically target the restoration of liver parenchyma by neutralizing toxic proteins produced during prolonged chronic inflammation. By blocking and removing denatured proteins that alter hepatic tissue, the composition facilitates the remodeling of fibrotic structures and the removal of scar tissue. Ascorbic Acid and L-Arginine act as essential catalysts, enhancing cell adhesion and synergizing with flavonoids to accelerate the regeneration of healthy liver cells.
Immune Modulation and Endothelial Stability. This preparation serves as a critical supplement to stabilize the endothelium and maintain cortisol levels within physiological limits. A key breakthrough in this formulation is its ability to stimulate the production and optimize the response of B lymphocytes, strengthening the body's adaptive immune system. Furthermore, the composition is designed to stimulate the release of growth hormones, fostering an internal environment conducive to cellular repair.
Clinical Significance and Oncogenic Prevention: While numerous therapies for hepatitis and cirrhosis are under global investigation, the efficacy of this specific formulation represents a significant advancement, validated by 8 years of longitudinal follow-up data. The precise ratios of these pharmaceutical ingredients are calculated to maximize their therapeutic impact in preventing and treating acute/chronic hepatitis and advanced cirrhosis. Crucially, the composition effectively arrests the progression to Hepatocellular Carcinoma (HCC) and significantly reduces the risk of post-treatment recurrence.
- Conditions
- Hepatitis B Virus Infection
- Being tested
- Flavonoid, Tenofovir
- Keywords
- Acid Ascorbic, L-Arginine hydrochloride, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, Rutin, Kaempferol
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavonoidDrug
Also called Tenofovir + SB Flavon
The daily maintenance, Tenofovir 150mg + SB Flavon 1345mg dose is to be taken 2 times a day, 1 tablet each time.
The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma at an early stage. The product is Acid ascorbic, L-Arginine hydrochloride, Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, Rutin.
Use these ingredients to protect liver cell membranes, preventing the growth of HBV in the body.
TenofovirDrug
The daily maintenance, Tenofovir 300mg dose is to be taken 1 time a day, 1 tablet each time.
The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir 300mg + SB Flavon | Experimental | Enhanced resistance to Hepatitis B Virus was demonstrated across all patient subgroups-including those with cirrhosis and HCC-following the administration of a Tenofovir and SB Flavon regimen. Receives: Drug: Flavonoid; Drug: Tenofovir |
| Tenofovir 300mg | Experimental | While Tenofovir monotherapy provided baseline experimental benefits in HBV resistance, the integration of SB Flavon resulted in superior clinical outcomes... Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Liver Stiffness Measurement (LSM) as an Indicator of Fibrosis The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis
Evaluation of hepatic fibrosis regression using Transient Elastography (Fibroscan). The study measures the success rate of transitioning from advanced cirrhosis (Stage F3- F4, typically >12.5 kPa) to lower fibrosis stages (F2 or F1).
Measured: Baseline, Year 1, Year 2, and Year 3.
Incidence of Hepatocellular Carcinoma (HCC) Development
The rate of participants progressing to HCC. This metric is monitored via serum Alpha-Fetoprotein (AFP) levels and periodic diagnostic imaging every six months (Ultrasound/CT/MRI). Success is defined as the absence of malignant transformation or recurrence.
Measured: Every 6 months up to 3 years
Secondary outcomes (3)
Number of participants with improvement in hepatic synthetic function measured via serum Albumin levels
Assessment of the liver's ability to synthesize proteins by measuring serum Albumin levels.
Unit of Measure: g/L
Measured: Every 6 months up to 3 years.
Number of participants with improvement in hepatic synthetic function measured via International Normalized Ratio (INR)
Assessment of the liver's coagulation factor synthesis capacity by measuring the International Normalized Ratio (INR).
Unit of Measure: Ratio (or Unitless)
Measured: Every 6 months up to 3 years.
Change in liver stiffness measurement via transient elastography
Evaluation of liver tissue stiffness using ultrasound-based sound waves to monitor the progression or reversal of cirrhosis.
Unit of Measure: kilopascals (kPa)
Measured: Every 6 months up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start30 Nov 2015
- Primary completion10 Oct 2025
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Responsible party
- Sponsor
- Investigators
- Nguyen Thi Trieu, MD, Study director, Trieu, Nguyen Thi, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084948
- Sponsor's protocol ID
- SB Flavon
- Acronym
- Flavonoids
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of SB Flavon in the Treatment of Advanced (F3-F4) HBV-related Cirrhosis and Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07084948
- Acronym / sponsor ID
- Flavonoids / SB Flavon
- Conditions
- Hepatitis B Virus Infection
- Keywords
- Acid Ascorbic, L-Arginine hydrochloride, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, Rutin, Kaempferol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 25 Jul 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.
SB Flavonoids for Advanced Liver Disease ManagementSB Flavonoids represents a multi-target therapeutic composition engineered for the comprehensive management of Hepatitis (Acute and Chronic), Advanced Cirrhosis (F3)-(F4), and Early-stage Hepatocellular Carcinoma (HCC).The formulation features a synergistic complex of Ascorbic Acid, L-Arginine Hydrochloride, and a high-potency flavonoid blend, including Kaempferol, Urinariaflavone, Quercetin, Rutin, and 5,6-dihydroxy-7,8,4'-trimethoxy-flavone. This combination exerts a powerful hepatoprotective and antifibrotic effect by:
Structural Regeneration: Promoting the repair and regeneration of functional liver parenchyma while stabilizing hepatocyte membranes to mitigate oxidative stress.
Bioreversal of Fibrosis: Actively inhibiting the activation of pro-fibrogenic cells (hepatic stellate cells) and remodeling the extracellular matrix to reverse advanced (F3)-(F4) fibrosis.
Oncogenic Suppression: Inhibiting the proliferation of malignant cells to prevent the progression of early-stage liver cancer.
Homeostatic Restoration: Providing essential molecular precursors to strengthen the host's immune surveillance, reduce chronic inflammation, and restore the liver's physiological and biochemical homeostasis.By addressing both viral-induced damage and structural degradation, SB Flavonoids offers a novel pathway for restoring hepatic function and systemic health in patients with progressive liver diseases.
Detailed description
Therapeutic Composition and Mechanism of Action. The core of this pharmaceutical composition is a synergistic complex of Ascorbic Acid, L-Arginine Hydrochloride, and a high-potency flavonoid blend (Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, and Rutin). These compounds function as pivotal agents in the protection of hepatocyte membranes, mitigation of oxidative stress, and preservation of the liver's structural integrity.
Structural Regeneration and Fibrosis Reversal. The selected flavonoids specifically target the restoration of liver parenchyma by neutralizing toxic proteins produced during prolonged chronic inflammation. By blocking and removing denatured proteins that alter hepatic tissue, the composition facilitates the remodeling of fibrotic structures and the removal of scar tissue. Ascorbic Acid and L-Arginine act as essential catalysts, enhancing cell adhesion and synergizing with flavonoids to accelerate the regeneration of healthy liver cells.
Immune Modulation and Endothelial Stability. This preparation serves as a critical supplement to stabilize the endothelium and maintain cortisol levels within physiological limits. A key breakthrough in this formulation is its ability to stimulate the production and optimize the response of B lymphocytes, strengthening the body's adaptive immune system. Furthermore, the composition is designed to stimulate the release of growth hormones, fostering an internal environment conducive to cellular repair.
Clinical Significance and Oncogenic Prevention: While numerous therapies for hepatitis and cirrhosis are under global investigation, the efficacy of this specific formulation represents a significant advancement, validated by 8 years of longitudinal follow-up data. The precise ratios of these pharmaceutical ingredients are calculated to maximize their therapeutic impact in preventing and treating acute/chronic hepatitis and advanced cirrhosis. Crucially, the composition effectively arrests the progression to Hepatocellular Carcinoma (HCC) and significantly reduces the risk of post-treatment recurrence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir 300mg + SB Flavon | Experimental | Drug: Flavonoid, Drug: TenofovirEnhanced resistance to Hepatitis B Virus was demonstrated across all patient subgroups-including those with cirrhosis and HCC-following the administration of a Tenofovir and SB Flavon regimen. |
| Tenofovir 300mg | Experimental | Drug: TenofovirWhile Tenofovir monotherapy provided baseline experimental benefits in HBV resistance, the integration of SB Flavon resulted in superior clinical outcomes... |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with underlying medical conditions who have been taking medications for these conditions.
- Patients with AIDS, HIV, HBV, HCV, and patients with co-infections.
- The cancer patients are stable.
- Patients with congenital or acquired immunodeficiency.
Key exclusion criteria (2 listed)
- Unstable cancer patients.
- Decompensated cirrhosis.
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 |
|---|---|---|
| FlavonoidAlso: Tenofovir + SB FlavonThe daily maintenance, Tenofovir 150mg + SB Flavon 1345mg dose is to be taken 2 times a day, 1 tablet each time. The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma at an early stage. The product is Acid ascorbic, L-Arginine hydrochloride, Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, Rutin. Use these ingredients to protect liver cell membranes, preventing the growth of HBV in the body. | Drug | Tenofovir 300mg + SB Flavon |
| TenofovirThe daily maintenance, Tenofovir 300mg dose is to be taken 1 time a day, 1 tablet each time. The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma. | Drug | Tenofovir 300mg, Tenofovir 300mg + SB Flavon |
Primary outcome
Reduction in Liver Stiffness Measurement (LSM) as an Indicator of Fibrosis The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis
Time frame: Baseline, Year 1, Year 2, and Year 3.
Evaluation of hepatic fibrosis regression using Transient Elastography (Fibroscan). The study measures the success rate of transitioning from advanced cirrhosis (Stage F3- F4, typically >12.5 kPa) to lower fibrosis stages (F2 or F1).
Incidence of Hepatocellular Carcinoma (HCC) Development
Time frame: Every 6 months up to 3 years
The rate of participants progressing to HCC. This metric is monitored via serum Alpha-Fetoprotein (AFP) levels and periodic diagnostic imaging every six months (Ultrasound/CT/MRI). Success is defined as the absence of malignant transformation or recurrence.
3 secondary outcomes
Number of participants with improvement in hepatic synthetic function measured via serum Albumin levels
Time frame: Every 6 months up to 3 years.
Number of participants with improvement in hepatic synthetic function measured via International Normalized Ratio (INR)
Time frame: Every 6 months up to 3 years.
Change in liver stiffness measurement via transient elastography
Time frame: Every 6 months up to 3 years.
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 5 Jun 2026.
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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.
Nguyen Thi Trieu, MD study director
Trieu, Nguyen Thi, M.D.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flavonoid and Tenofovir in people with Hepatitis B Virus Infection, run by Trieu, Nguyen Thi, M.D. at 2 sites in 2 countries.
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 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Vietnam. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in Liver Stiffness Measurement (LSM) as an Indicator of Fibrosis The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (time frame: Baseline, Year 1, Year 2, and Year 3.). The study lists 2 primary outcomes in all. 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 5 Jun 2026.