Composition for Treating Cirrhosis and Liver Cancer (SB-1121)
NCT ID: NCT05178303
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
134 participants
INTERVENTIONAL
2015-11-30
2021-11-10
Brief Summary
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Detailed Description
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The pharmaceutical ingredients involved in the composition are calculated to increase their effectiveness in preventing and curing cirrhosis and Hcc.
Currently, many preparations have been and are being studied to fight against cirrhosis and liver cancer globally. The effectiveness of this preparation is a new finding which has been proven over 5 years of follow-up.
Pregnenolone is a cortisol precursor. Cortisol plays an important role in several systems in the body, including the immune system(in the cycle of the immune system to produce B lymphocytes). This ingredient is used as a supplement to stabilize the endothelium, regulate the amount of cortisol within normal limits, and help the body produce B lymphocytes with a good response.
Kaempferol is a flavonoid that participates in cell protection against toxic proteins which were produced during prolonged inflammation; blocking the action and removing denatured proteins that change the parenchyma of liver cells. The selected flavonoids repaired the fibrotic structure of liver parenchyma after chronic inflammation. Ascorbic acid, pyridoxine 5-phosphate, and L-arginine help to facilitate biological functions in cell adhesion, synergize with flavonoids in cell membrane protection, structural repair, and liver cell regeneration.
Ascorbic acid, pyridoxine 5-phosphate act as enzymes that catalyze processes conveniently.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cirrhosis
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.
SB-1121(1)
The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.
Cirrhosis/Hcc "stable"
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.
SB-1121(2)
The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.
Interventions
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SB-1121(1)
The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.
SB-1121(2)
The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with AIDS, HIV, HBV, HCV, and patients with co-infections.
* The cancer patients are stable.
* Patients with congenital or acquired immunodeficiency.
Exclusion Criteria
* Decompensated cirrhosis.
18 Years
80 Years
ALL
Yes
Sponsors
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Tran Minh Duc
UNKNOWN
Nguyen Thi Trieu, MD
INDIV
Responsible Party
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Nguyen Thi Trieu, MD
Scientific Manager
Principal Investigators
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Tran Minh Cam Tu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Saigon Biopharma Company Limited
Locations
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Saigon Biopharma LLC
Wilmington, Delaware, United States
Saigon Biopharma Company Limited
Ho Chi Minh City, , Vietnam
Countries
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References
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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.
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/
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.
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.
Flisiak R. Role of Ito cells in the liver function. Pol J Pathol. 1997;48(3):139-45.
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.
19. IPSC-derived 3D human fatty liver models Maddalena Parafati, Siobhan Malany, in iPSCs in Tissue Engineering, 2021
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.
Related Links
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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
Other Identifiers
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Cirrhosis and Hcc
Identifier Type: -
Identifier Source: org_study_id
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