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

NCT07084948 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: SB Flavon
• Study Type: interventional
• Target: 134
• Locations: 2 countries
• Sites: 2

Brief 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 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.

Conditions

Hepatitis B Virus Infection

Keywords

Acid Ascorbic; L-Arginine hydrochloride; Urinariaflavone; 5,6-dihydroxy-7,8,4'-trimethoxy-flavone; Quercetin; Rutin; Kaempferol

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Every 6 months up to 3 years

Secondary Outcomes (3)

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

  Every 6 months up to 3 years.

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

  Every 6 months up to 3 years.

• Change in liver stiffness measurement via transient elastography

  Every 6 months up to 3 years.

Study Arms (2)

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.

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...

Drug: Tenofovir

Interventions

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.

Also known as: Tenofovir + SB Flavon

Tenofovir 300mg + 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.

Tenofovir 300mg; Tenofovir 300mg + SB Flavon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unstable cancer patients.
• Decompensated cirrhosis.

Sponsors & Collaborators

• Trieu, Nguyen Thi, M.D.: lead

Study Sites (2)

Saigon Biopharma LLC

Wilmington, Delaware, 19801-6601, United States

Location

Saigon Biopharma Company Limited

Hồ Chí Minh, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Flavonoids; Tenofovir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines

Study Officials

• Nguyen Thi Trieu, MD

  Trieu, Nguyen Thi, M.D.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 25, 2025
• Study Start: November 30, 2015
• Primary Completion: October 10, 2025
• Study Completion: April 20, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

VN (1); US (1)