Portal HypertensionPhase 4NCT02945982
Treatment of Moderate and Severe Cirrhotic Portal Hypertension Due to HBV With Fuzheng Huayu and Entecavir
A Phase 4 study testing Entecavir+Carvedilol and Entecavir+Carvedilol+ Fuzheng Huayu in people with Portal Hypertension, run by ShuGuang Hospital at 3 sites in China.
Trial summary
Portal hypertension is a common pathology in chronic liver disease, particularly in liver cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Entecavir+Carvedilol and Entecavir+Carvedilol+ Fuzheng Huayu
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 3 sitesChina
- Study dates
- 5 Apr 2018to Jun 2021
- Phase
- Phase 4
- 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
- More than 6 months history of serum positive HBsAg
- Abdominal ultrasonogram or CT scan or liver-biopsy specimen indicates liver cirrhosis
- Age 18-65
- Child-Pugh<7 (Stage A)
- Without portal hypertension（Endoscopy indicates no signs of gastroesophageal varices.）
- Moderate and Severe of portal hypertension（Endoscopy indicates signs of gastroesophageal varices that is line shape without red wales or spots and less than 0.3cm of diameter.）
- The patient or the patient's guardian agrees to participate the random controlled trial and sign the Informed Consent Form.
Who cannot join
- Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
- Decompensated cirrhosis、The Child-Pugh score≥7
- Low-grade Cirrhotic Portal Hypertension.
- Severe grade of portal hypertension（Endoscopy indicates signs of gastroesophageal varices that is catenulate/nodular shape with or without red wales or spots and more than 1.0cm of diameter.）
- Decompensated liver cirrhosis Liver cancer
- Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
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- Have psychiatric history or uncontrollable epilepsy patient.
- Uncontrollable diabetic patient
- History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
- Severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
- In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow transplantation and stem cell transplantation.
- Immunocompromised patients: such as HIV infection or take immunosuppressor or glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3 months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer chemotherapy) and radioactive therapy.
- Gestation or lactation period women and women who plan to get pregnant during the study period.
- Patient who are allergy to the experimental drug.
- Using history of anti-viral or anti-fibrosis drug within 6 months.
- Patients who are participating other trials.
- Other situation where PI thinks the patient should be excluded.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Ruijin Hospital
Shanghai
hui Wang
- Recruiting
Shanghai Zhongshan Hospital
Shanghai
Wei Jiang
- Recruiting
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Jing Lv
About this study
Official title: A Randomized, Placebo-Controlled, Open-label, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir and Carvedilol in Moderate and Severe Cirrhotic Portal Hypertension Due to Hepatitis B Virus
Portal hypertension is a common pathology in chronic liver disease, particularly in liver cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The basic reason for portal hypertension in HBV is the largely deposition of hepatic extracellular matrixes which causes high pressure in liver vessels. One of the most common symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate and bleeding rate of gastroesophageal varices.
Read the detailed description
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for reverse rate of gastroesophageal varices in patients with Moderate and Severe cirrhotic portal hypertension due to hepatitis B virus.
- Conditions
- Portal Hypertension
- Being tested
- Entecavir+Carvedilol, Entecavir+Carvedilol+ Fuzheng Huayu
- Keywords
- Portal Hypertension, Fuzheng Huayu, Hepatitis B
- Medical subject headings
- Hypertension, Portal, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir+CarvedilolDrug
The subjects will be taking half a Carvedilol per day at first week and one Carvedilol per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day for 96 weeks.
Entecavir+Carvedilol+ Fuzheng HuayuDrug
The subjects will be taking half a Carvedilol tablet per day at first week and one Carvedilol tablets per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Entecavir/Carvedilol | Placebo comparator | Tablet with Entrcavir and Carvedilol Receives: Drug: Entecavir+Carvedilol |
| Entecavir/Carvedilol/ Fuzheng Huayu | Experimental | Tablet with Entrcavir and Carvedilol+ Tablet with Fuzheng Huayu Receives: Drug: Entecavir+Carvedilol+ Fuzheng Huayu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc
Measured: 96 weeks
Grading varices
Measured: 96 weeks
Incidence of liver cancer
Measured: 96 weeks
Noninvasive portal hypertension index
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start5 Apr 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies 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
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Zhongshan Hospital, Longhua Hospital, Shanghai Public Health Clinical Center
- Responsible party
- Principal investigator, Liu Chenghai, ShuGuang Hospital
- Investigators
- CHENGHAI LIU, PHD,MD, Principal investigator, ShuGuang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945982
- Sponsor's protocol ID
- SGHLC20161023004
- Status last verified
- Feb 2020
- First submitted
- 23 Oct 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Open-label, Multi-Center Study to Assess the Efficacy and Safety of Fuzheng Huayu Combined With Entecavir and Carvedilol in Moderate and Severe Cirrhotic Portal Hypertension Due to Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT02945982
- Acronym / sponsor ID
- SGHLC20161023004
- Conditions
- Portal Hypertension
- Keywords
- Portal Hypertension, Fuzheng Huayu, Hepatitis B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Zhongshan Hospital, Longhua Hospital, Shanghai Public Health Clinical Center
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Portal hypertension is a common pathology in chronic liver disease, particularly in liver cirrhosis. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The basic reason for portal hypertension in HBV is the largely deposition of hepatic extracellular matrixes which causes high pressure in liver vessels. One of the most common symptoms of cirrhotic portal hypertension is gastroesophageal varices.The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix may have a great benefit. Therefore, antivirals therapy is also a basic treatment for low-grade cirrhotic portal hypertension. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can relieve the pressure of liver vessels and decline incidence rate and bleeding rate of gastroesophageal varices.
Detailed description
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for reverse rate of gastroesophageal varices in patients with Moderate and Severe cirrhotic portal hypertension due to hepatitis B virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entecavir/Carvedilol | Placebo comparator | Drug: Entecavir+CarvedilolTablet with Entrcavir and Carvedilol |
| Entecavir/Carvedilol/ Fuzheng Huayu | Experimental | Drug: Entecavir+Carvedilol+ Fuzheng HuayuTablet with Entrcavir and Carvedilol+ Tablet with Fuzheng Huayu |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- More than 6 months history of serum positive HBsAg
- Abdominal ultrasonogram or CT scan or liver-biopsy specimen indicates liver cirrhosis
- Age 18-65
- Child-Pugh<7 (Stage A)
- Without portal hypertension（Endoscopy indicates no signs of gastroesophageal varices.）
Key exclusion criteria (17 listed)
- Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
- Decompensated cirrhosis、The Child-Pugh score≥7
- Low-grade Cirrhotic Portal Hypertension.
- Severe grade of portal hypertension（Endoscopy indicates signs of gastroesophageal varices that is catenulate/nodular shape with or without red wales or spots and more than 1.0cm of diameter.）
- Decompensated liver cirrhosis Liver cancer
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 |
|---|---|---|
| Entecavir+CarvedilolThe subjects will be taking half a Carvedilol per day at first week and one Carvedilol per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day for 96 weeks. | Drug | Entecavir/Carvedilol |
| Entecavir+Carvedilol+ Fuzheng HuayuThe subjects will be taking half a Carvedilol tablet per day at first week and one Carvedilol tablets per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks. | Drug | Entecavir/Carvedilol/ Fuzheng Huayu |
Primary outcome
Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc
Time frame: 96 weeks
Grading varices
Time frame: 96 weeks
Incidence of liver cancer
Time frame: 96 weeks
Noninvasive portal hypertension index
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
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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.
CHENGHAI LIU, PHD,MD principal investigator
ShuGuang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir+Carvedilol and Entecavir+Carvedilol+ Fuzheng Huayu in people with Portal Hypertension, run by ShuGuang Hospital at 3 sites 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 7 inclusion and 17 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JING LV, MD (+86-21-20256521, liver125@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical events: Variceal hemorrhage, Ascites, Encephalopathy, etc (time frame: 96 weeks). The study lists 4 primary outcomes in all. 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 13 Feb 2020.