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NCT Number: NCT07084948

Inhibition of HBV Replication and Biological Reversal of Cirrhosis (F3-F4) and HCC by Flavonoids

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.

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Key information

Conditions

Hepatitis B Virus Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saigon Biopharma LLC, Wilmington, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Unstable cancer patients.
  • Decompensated cirrhosis.

Treatment and study plan

Flavonoid

Drug

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.

Other names: Tenofovir + SB Flavon

Tenofovir

Drug

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Number of participants with improvement in hepatic synthetic function measured via serum Albumin levels

    Time frame: Every 6 months up to 3 years.

    Assessment of the liver's ability to synthesize proteins by measuring serum Albumin levels.

    Unit of Measure: g/L

  2. Number of participants with improvement in hepatic synthetic function measured via International Normalized Ratio (INR)

    Time frame: Every 6 months up to 3 years.

    Assessment of the liver's coagulation factor synthesis capacity by measuring the International Normalized Ratio (INR).

    Unit of Measure: Ratio (or Unitless)

  3. Change in liver stiffness measurement via transient elastography

    Time frame: Every 6 months up to 3 years.

    Evaluation of liver tissue stiffness using ultrasound-based sound waves to monitor the progression or reversal of cirrhosis.

    Unit of Measure: kilopascals (kPa)

Sponsors and collaborators

Lead sponsor

Trieu, Nguyen Thi, M.D.

Indiv

Registry information

Official study title

Therapeutic Efficacy of SB Flavon in the Treatment of Advanced (F3-F4) HBV-related Cirrhosis and Hepatocellular Carcinoma

Acronym: Flavonoids

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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