Hepatic EncephalopathyPhase 3NCT05128305
Integrated Traditional Chinese and Clinical Medicine for Chronic Hepatitis B and Its Complication
A Phase 3 study testing traditional Chinese medicine1 and traditional Chinese medicine 2 in people with Hepatic Encephalopathy and Cirrhosis, Liver, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Hepatic encephalopathy is the most common complication after TIPS, and hepatic encephalopathy occurs in almost all portosystemic shunts. For patients with severe upper gastrointestinal bleeding or refractory ascites in the decompensated chronic hepatitis B, transjugular intrahepatic portosystemic shunt (TIPS) is a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis, Liver, Portosystemic Shunt
- What is being tested?
- traditional Chinese medicine1 and traditional Chinese medicine 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TIPS treatment criteria in line with the 2017 edition of the "Expert Consensus on Transjugular Intrahepatic Portosystemic Shunt" were selected to include patients with hepatitis B cirrhosis and Child-pugh grade A and B after TIPS surgery.
- Patients with liver cirrhosis, portal hypertension, bleeding from esophagus and gastric varices; refractory pleural and ascites due to liver cirrhosis; incomplete portal vein/localized thrombosis in liver cirrhosis or primary and secondary prevention of cirrhosis, portal hypertension, esophagus and gastric varices bleeding.
Who cannot join
- Severe blood coagulation disorder (PTA≤20%) or platelets lower than 30×109/L;
- Child-pugh classification of liver function C;
- Those with respiratory and circulatory dysfunction;
- Those whose systemic or focal infections have not been effectively controlled;
- Patients with moderate to severe malnutrition;
- Extensive primary or metastatic liver malignant tumors;
- Those who are highly allergic to the products and drugs used in the treatment process.
Trial locations and contacts
1 site in 1 country.
China1 site
he First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250010
fengyan Wang, PhD
About this study
Official title: Shandong Provincial Integrated Traditional Chinese and Clinical Medicine(Chronic Hepatitis B and Its Complication) Prevention and Treatment Project
Hepatic encephalopathy is the most common complication after TIPS, and hepatic encephalopathy occurs in almost all portosystemic shunts. For patients with severe upper gastrointestinal bleeding or refractory ascites in the decompensated chronic hepatitis B, transjugular intrahepatic portosystemic shunt (TIPS) is a very effective treatment. However, due to the severe complications such as hepatic encephalopathy after TIPS, the clinical application of TIPS is limited. Literature studies have shown that the incidence of encephalopathy after TIPS is about 35%. TIPS reduces the portal vena blood flow into the liver by establishing a new channel. But at the same time, the toxic substances from the gastrointestinal tract and other organs do not enter the liver to detoxify, and are more likely to enter the brain, leading to hepatic encephalopathy.
Moreover, studies have found that the liver and the intestine originate from the same germ layer and are closely related to each other in anatomy and function. There are a large number of microorganisms living in the intestinal tract. Normally, the intestinal tract, as the first defense of the human body, can effectively prevent bacteria and their products from entering the bloodstream. In cirrhosis and portal hypertension, blood return disorder causes intestinal damage. A series of microbes and product endotoxins such as gram-negative bacteria will enter the blood through the injury, and the toxins in the peripheral blood will enter the brain and cause hepatic encephalopathy happened.
The research team's early treatment plan with integrated traditional Chinese and Western medicine proved that it greatly reduced the incidence of hepatic encephalopathy after TIPS. And improve the clinical symptoms and signs of patients with liver cirrhosis, and improve the quality of life and survival of patients.
- Being tested
- traditional Chinese medicine1 and traditional Chinese medicine 2
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicine1 and traditional Chinese medicine 2Drug
Also called traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulant
We use two traditional Chinese medicine prescriptions to intervene in patients after TIPS
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | traditional chinese medicine 1 and traditional chinese medicine 2 simulant Receives: Drug: traditional Chinese medicine1 and traditional Chinese medicine 2 |
| group 2 | Experimental | traditional chinese medicine 1 simulant and traditional chinese medicine 2 Receives: Drug: traditional Chinese medicine1 and traditional Chinese medicine 2 |
| group 3 | Experimental | traditional chinese medicine 1 and traditional chinese medicine 2 Receives: Drug: traditional Chinese medicine1 and traditional Chinese medicine 2 |
| group 4 | Placebo comparator | traditional chinese medicine 1 simulant and traditional chinese medicine 2 simulant Receives: Drug: traditional Chinese medicine1 and traditional Chinese medicine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hepatic encephalopathy
The incidence of hepatic encephalopathy after 12 weeks of treatment.
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128305
- Sponsor's protocol ID
- CT-2020-1230
- Status last verified
- Nov 2021
- First submitted
- 10 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shandong Provincial Integrated Traditional Chinese and Clinical Medicine(Chronic Hepatitis B and Its Complication) Prevention and Treatment Project
- ClinicalTrials.gov ID
- NCT05128305
- Acronym / sponsor ID
- CT-2020-1230
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatic encephalopathy is the most common complication after TIPS, and hepatic encephalopathy occurs in almost all portosystemic shunts. For patients with severe upper gastrointestinal bleeding or refractory ascites in the decompensated chronic hepatitis B, transjugular intrahepatic portosystemic shunt (TIPS) is a very effective treatment. However, due to the severe complications such as hepatic encephalopathy after TIPS, the clinical application of TIPS is limited. Literature studies have shown that the incidence of encephalopathy after TIPS is about 35%. TIPS reduces the portal vena blood flow into the liver by establishing a new channel. But at the same time, the toxic substances from the gastrointestinal tract and other organs do not enter the liver to detoxify, and are more likely to enter the brain, leading to hepatic encephalopathy.
Moreover, studies have found that the liver and the intestine originate from the same germ layer and are closely related to each other in anatomy and function. There are a large number of microorganisms living in the intestinal tract. Normally, the intestinal tract, as the first defense of the human body, can effectively prevent bacteria and their products from entering the bloodstream. In cirrhosis and portal hypertension, blood return disorder causes intestinal damage. A series of microbes and product endotoxins such as gram-negative bacteria will enter the blood through the injury, and the toxins in the peripheral blood will enter the brain and cause hepatic encephalopathy happened.
The research team's early treatment plan with integrated traditional Chinese and Western medicine proved that it greatly reduced the incidence of hepatic encephalopathy after TIPS. And improve the clinical symptoms and signs of patients with liver cirrhosis, and improve the quality of life and survival of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: traditional Chinese medicine1 and traditional Chinese medicine 2traditional chinese medicine 1 and traditional chinese medicine 2 simulant |
| group 2 | Experimental | Drug: traditional Chinese medicine1 and traditional Chinese medicine 2traditional chinese medicine 1 simulant and traditional chinese medicine 2 |
| group 3 | Experimental | Drug: traditional Chinese medicine1 and traditional Chinese medicine 2traditional chinese medicine 1 and traditional chinese medicine 2 |
| group 4 | Placebo comparator | Drug: traditional Chinese medicine1 and traditional Chinese medicine 2traditional chinese medicine 1 simulant and traditional chinese medicine 2 simulant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TIPS treatment criteria in line with the 2017 edition of the "Expert Consensus on Transjugular Intrahepatic Portosystemic Shunt" were selected to include patients with hepatitis B cirrhosis and Child-pugh grade A and B after TIPS surgery.
- Patients with liver cirrhosis, portal hypertension, bleeding from esophagus and gastric varices; refractory pleural and ascites due to liver cirrhosis; incomplete portal vein/localized thrombosis in liver cirrhosis or primary and secondary prevention of cirrhosis, portal hypertension, esophagus and gastric varices bleeding.
Key exclusion criteria (7 listed)
- Severe blood coagulation disorder (PTA≤20%) or platelets lower than 30×109/L;
- Child-pugh classification of liver function C;
- Those with respiratory and circulatory dysfunction;
- Those whose systemic or focal infections have not been effectively controlled;
- Patients with moderate to severe malnutrition;
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 |
|---|---|---|
| traditional Chinese medicine1 and traditional Chinese medicine 2Also: traditional Chinese medicine1 simulant and traditional Chinese medicine 2 simulantWe use two traditional Chinese medicine prescriptions to intervene in patients after TIPS | Drug | group 1, group 2, group 3, group 4 |
Primary outcome
The incidence of hepatic encephalopathy
Time frame: 12 weeks of treatment
The incidence of hepatic encephalopathy after 12 weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing traditional Chinese medicine1 and traditional Chinese medicine 2 in people with Hepatic Encephalopathy and Cirrhosis, Liver, run by Qianfoshan Hospital at 1 site in China.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Nov 2021. 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 China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The incidence of hepatic encephalopathy (time frame: 12 weeks of treatment). 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 19 Nov 2021.