Composition for Treating Cirrhosis and Liver Cancer (SB-1121)

NCT05178303 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Cirrhosis and Hcc
• Study Type: interventional
• Target: 134
• Locations: 2 countries
• Sites: 2

Brief Summary

The composition treats cirrhosis and hepatocellular carcinoma (Hcc) at an early stage. The product is extracted from herbs, including Adenosma glutinosum extract, Eclipta prostrata extract, Phyllanthus urinaria extract, Impatiens balsamina extract, Ascorbic acid, pyridoxine 5-phosphate, L-Arginine hydrochloride, Pregnenolone acetate. These components have participated in repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, preventing liver cancer cell growth at an early stage. The composition supplements precursors which help the body strengthen antibodies and reduce the risk of inflammation, restore physiological and biochemical functions of liver cells after chronic inflammation.

Conditions

Cirrhosis of the Liver

Keywords

Liver; Cirrhosis; Hcc; Flavonoids; Pregnenolone; Ascorbic acid; B6

Outcome Measures

Primary Outcomes (1)

• The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)

  HBV, HCV,... injure healthy liver cells, causing cell death and inflammation. Healthy liver tissue is replaced with scar tissue and the liver is damaged.

  36 months

Secondary Outcomes (1)

• The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)

  36 months

Study Arms (2)

Cirrhosis

EXPERIMENTAL

Experimental benefits in resistance to cirrhosis were observed in all patients who had previously received certain components of the treatment for cirrhosis SB-1121(1) for various therapeutic purposes.

Drug: SB-1121(1)

Cirrhosis/Hcc "stable"

EXPERIMENTAL

Experimental benefits in resistance to cirrhosis/Hcc were observed in all patients who had previously received certain components of the treatment for cirrhosis SB-1121(2) for various therapeutic purposes.

Drug: SB-1121(2)

Interventions

SB-1121(1) DRUG

The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.

Also known as: Cirrhosis/SB-1121

Cirrhosis

SB-1121(2) DRUG

The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.

Also known as: Cirrhosis/Hcc/SB-1121

Cirrhosis/Hcc "stable"

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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

• Nguyen Thi Trieu, MD: lead
• Tran Minh Duc: collaborator

Study Sites (2)

Saigon Biopharma LLC

Wilmington, Delaware, 19801-6601, United States

Location

Saigon Biopharma Company Limited

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (8)

• Raza A, Sood GK. Hepatocellular carcinoma review: current treatment, and evidence-based medicine. World J Gastroenterol. 2014 Apr 21;20(15):4115-27. doi: 10.3748/wjg.v20.i15.4115.

  PMID: 24764650 RESULT

• Kalra A, Yetiskul E, Wehrle CJ, Tuma F. Physiology, Liver. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK535438/

  PMID: 30571059 RESULT

• Naran K, Nundalall T, Chetty S, Barth S. Principles of Immunotherapy: Implications for Treatment Strategies in Cancer and Infectious Diseases. Front Microbiol. 2018 Dec 21;9:3158. doi: 10.3389/fmicb.2018.03158. eCollection 2018.

  PMID: 30622524 RESULT

• Roth A, Schaffner W, Hertel C. Phytoestrogen kaempferol (3,4',5,7-tetrahydroxyflavone) protects PC12 and T47D cells from beta-amyloid-induced toxicity. J Neurosci Res. 1999 Aug 1;57(3):399-404.

  PMID: 10412031 RESULT

• Flisiak R. Role of Ito cells in the liver function. Pol J Pathol. 1997;48(3):139-45.

  PMID: 9401406 RESULT

• Kaestner KH. Progress in molecular biology and translational science. development, differentiation and disease of the para-alimentary tract. Preface. Prog Mol Biol Transl Sci. 2010;97:xi-xii. doi: 10.1016/B978-0-12-385233-5.00015-5. No abstract available.

  PMID: 21074727 RESULT

• 19. IPSC-derived 3D human fatty liver models Maddalena Parafati, Siobhan Malany, in iPSCs in Tissue Engineering, 2021

  RESULT

• Hennedige T, Venkatesh SK. Imaging of hepatocellular carcinoma: diagnosis, staging and treatment monitoring. Cancer Imaging. 2013 Feb 8;12(3):530-47. doi: 10.1102/1470-7330.2012.0044.

  PMID: 23400006 RESULT

Related Links

• Liver Cancer Risk Factors
• Viral Hepatitis and Liver Disease
• What does the liver do
• Flavonoids as Multi-target Inhibitors for Proteins Associated with Ebola Virus: In Silico Discovery Using Virtual Screening and Molecular Docking Studies
• Vitamin C Is an Essential Factor on the Anti-viral Immune Responses through the Production of Interferon-α/β at the Initial Stage of Influenza A Virus (H3N2) Infection
• The antiviral properties of vitamin C

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Tran Minh Cam Tu, Dr.

  Saigon Biopharma Company Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Manager
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: November 30, 2015
• Primary Completion: October 10, 2021
• Study Completion: November 10, 2021
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); VN (1)