Cirrhosis of the LiverPhase 4SB-1121NCT05178303
Composition for Treating Cirrhosis and Liver Cancer (SB-1121)
A Phase 4 study testing SB-1121(1) and SB-1121(2) in people with Cirrhosis of the Liver, run by Nguyen Thi Trieu, MD at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis of the Liver
- What is being tested?
- SB-1121(1) and SB-1121(2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Nov 2015to 10 Nov 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- 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
1 site in 1 country.
About this study
Official title: Composition for Treating Cirrhosis and Liver Cancer
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.
Read the detailed description
The composition is fractionally extracted from herbs. Flavonoids, isoflavonoids, and pregnenolone combined with ascorbic acid, pyridoxine 5-phosphate, L-arginine act as the key compounds in the regeneration of fibrosis liver cells, remove scar tissue, stimulate and release growth hormones, prevent progression to Hcc and prevent Hcc recurrence.
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
- Cirrhosis of the Liver
- Being tested
- SB-1121(1), SB-1121(2)
- Keywords
- Liver, Cirrhosis, Hcc, Flavonoids, Pregnenolone, Ascorbic acid, B6
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-1121(1)Drug
Also called Cirrhosis/SB-1121
The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.
SB-1121(2)Drug
Also called Cirrhosis/Hcc/SB-1121
The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SB-1121(2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness Measurement (LSM)
Liver stiffness is assessed by transient elastography to evaluate the degree of cirrhosis. Higher values indicate greater tissue stiffness. This measure reports the absolute liver stiffness values at the 36-month time point.
Measured: 36 months
Secondary outcomes (1)
Liver Stiffness Measurement (LSM) for HCC Group
Liver stiffness is assessed by transient elastography to evaluate tissue changes. This secondary outcome specifically analyzes the subgroup of participants who presented with hepatocellular carcinoma (HCC) within the study arms.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start30 Nov 2015
- Primary completion10 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cirrhosis of the LiverStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Thi Trieu, MD
- Responsible party
- Sponsor-investigator, Nguyen Thi Trieu, MD, Trieu, Nguyen Thi, M.D.
- Investigators
- Tran Minh Cam Tu, Dr., Principal investigator, Saigon Biopharma Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178303
- Sponsor's protocol ID
- Cirrhosis and Hcc
- Acronym
- SB-1121
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2021
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composition for Treating Cirrhosis and Liver Cancer
- ClinicalTrials.gov ID
- NCT05178303
- Acronym / sponsor ID
- SB-1121 / Cirrhosis and Hcc
- Conditions
- Cirrhosis of the Liver
- Keywords
- Liver, Cirrhosis, Hcc, Flavonoids, Pregnenolone, Ascorbic acid, B6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nguyen Thi Trieu, MD
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Posted 6 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The composition is fractionally extracted from herbs. Flavonoids, isoflavonoids, and pregnenolone combined with ascorbic acid, pyridoxine 5-phosphate, L-arginine act as the key compounds in the regeneration of fibrosis liver cells, remove scar tissue, stimulate and release growth hormones, prevent progression to Hcc and prevent Hcc recurrence.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis | Experimental | Drug: SB-1121(1)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. |
| Cirrhosis/Hcc "stable" | Experimental | Drug: SB-1121(2)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| SB-1121(1)Also: Cirrhosis/SB-1121The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time. | Drug | Cirrhosis |
| SB-1121(2)Also: Cirrhosis/Hcc/SB-1121The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time. | Drug | Cirrhosis/Hcc "stable" |
Primary outcome
Liver Stiffness Measurement (LSM)
Time frame: 36 months
Liver stiffness is assessed by transient elastography to evaluate the degree of cirrhosis. Higher values indicate greater tissue stiffness. This measure reports the absolute liver stiffness values at the 36-month time point.
1 secondary outcome
Liver Stiffness Measurement (LSM) for HCC Group
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Flavonoids as Multi-target Inhibitors for Proteins Associated with Ebola Virus: In Silico Discovery Using Virtual Screening and Molecular Docking StudiesLink provided by the sponsor.
- 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) InfectionLink provided by the sponsor.
- The antiviral properties of vitamin CLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tran Minh Cam Tu, Dr. principal investigator
Saigon Biopharma Company Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SB-1121(1) and SB-1121(2) in people with Cirrhosis of the Liver, run by Nguyen Thi Trieu, MD at 1 site in Vietnam.
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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Liver Stiffness Measurement (LSM) (time frame: 36 months). 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 6 Nov 2026.