Chronic Hepatitis BNCT05357183
The Study on Clinical Outcome and Treatment Optimization of Chronic Hepatitis B Patients With Hypoviremia
An observational study of Chronic Hepatitis B, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PEG-IFN
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Dec 2024
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Chronic hepatitis B patients with Hypoviremia after Das therapy
Who may be able to join
- Aged from 16 to 60;
- The positive time of HBsAg was 6 months,
- 48 weeks of treatment with ETV, TDF or TAF, including HBeAg positive and negative patients;
- High sensitive reagent was used to confirm that the low level of serum HBV DNA was 20 IU / ml-2000 IU / ml.
- Good compliance and sign informed consent.
Who cannot join
- Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis;
- Those who have used interferon within 6 months;
- at the same time, it is associated with other virus infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, AIDS virus, etc;
- in addition to hepatitis B, there are other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, serious complications of diabetes and adrenal diseases), immune deficiency diseases, and severe infections; Active or suspected malignant tumor or history of malignant tumor;
- 6 months before enrollment or currently receiving corticosteroids, immunosuppressants and chemotherapeutic drugs;
- Complicated with alcoholic liver disease, autoimmune liver disease and other liver diseases;
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- HBV resistant patients;
- Other situations that the researcher believes are not suitable for inclusion.
- PegIFN α Treatment contraindications:
- Prohibited for known pairs α- Patients who are allergic to interferon, E. coli products, polyethylene glycol or any component of this product;
- It is forbidden to be used in patients with autoimmune hepatitis;
- Pregnant and lactating women;
- Central nervous system diseases, mental diseases, uncontrolled epilepsy, non withdrawal of alcohol / drug abuse, decompensated liver cirrhosis, symptomatic heart disease, uncontrolled autoimmune diseases and severe thyroid function diseases;
- Absolute neutrophil count before treatment ≤ 1.0 × 109 / L, platelet ≤ 80 × 109/L。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Yao Xie, Doctor, 8610-84322200 ext. 2489, xieyao00120184@sina.com
About this study
Official title: The Clinical Outcomes of Optimize Treatment of Chronic Hepatitis B Patients With Low-level Viremia Undergoing Nucleoside Treatment
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.
Read the detailed description
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of liver cancer, which brings huge economic burden and life threat to our people. 84% - 92% of hepatocellular carcinoma (HCC) in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B Na treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of liver cancer.
- Conditions
- Chronic Hepatitis B
- Being tested
- PEG-IFN
- Keywords
- Chronic Hepatitis B infection, low-level viremia, optimize treatment, Nucleoside analogues
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IFNDrug
PEG-IFN 180 or 135 micrograms, subcutaneously injected once a week, with a personalized treatment course of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN optimized treatment group | Patients received optimized treatment of NAs (ETV + TDF or ETV + TAF) combined with PEG-IFN ETV 0.5 mg, TDF 300 mg or TAF 25 mg, oral once a day, PEG-IFN 180 or 135 micrograms, subcutaneous injection once a week, with a personalized course of treatment of 24 weeks. Receives: Drug: PEG-IFN | |
| NAs optimized treatment group | Patients received NAS (ETV + TDF or ETV + TAF) combination therapy and continued NAs maintenance therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HCC during the project study
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Measured: 48 weeks
Secondary outcomes (5)
The negative conversion rate of HBV DNA after 48 weeks of treatment was optimized (below the detection line of highly sensitive detection reagent)
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Measured: 48 weeks
The incidence of HBsAg disappearance during the study period;
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Measured: 48 weeks
HBeAg seroconversion rate in HBeAg positive patients;
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Measured: 48 weeks
Incidence of chronic hepatitis B during the study period
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Measured: 48 weeks
To study the incidence of complications such as cirrhotic ascites and upper gastrointestinal bleeding during long-term follow-up.
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital/5th Medical Center of Chinese PLA General Hospital, Beijing YouAn Hospital
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357183
- Sponsor's protocol ID
- CFH2022-1-2172
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 12 May 2022
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes of Optimize Treatment of Chronic Hepatitis B Patients With Low-level Viremia Undergoing Nucleoside Treatment
- ClinicalTrials.gov ID
- NCT05357183
- Acronym / sponsor ID
- CFH2022-1-2172
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B infection, low-level viremia, optimize treatment, Nucleoside analogues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital/5th Medical Center of Chinese PLA General Hospital, Beijing YouAn Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 May 2022 (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.
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.
Detailed description
Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of liver cancer, which brings huge economic burden and life threat to our people. 84% - 92% of hepatocellular carcinoma (HCC) in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B Na treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of liver cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN optimized treatment group | – | Drug: PEG-IFNPatients received optimized treatment of NAs (ETV + TDF or ETV + TAF) combined with PEG-IFN ETV 0.5 mg, TDF 300 mg or TAF 25 mg, oral once a day, PEG-IFN 180 or 135 micrograms, subcutaneous injection once a week, with a personalized course of treatment of 24 weeks. |
| NAs optimized treatment group | – | –Patients received NAS (ETV + TDF or ETV + TAF) combination therapy and continued NAs maintenance therapy. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Chronic hepatitis B patients with Hypoviremia after Das therapy
Key inclusion criteria (5 listed)
- Aged from 16 to 60;
- The positive time of HBsAg was 6 months,
- 48 weeks of treatment with ETV, TDF or TAF, including HBeAg positive and negative patients;
- High sensitive reagent was used to confirm that the low level of serum HBV DNA was 20 IU / ml-2000 IU / ml.
- Good compliance and sign informed consent.
Key exclusion criteria (14 listed)
- Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis;
- Those who have used interferon within 6 months;
- at the same time, it is associated with other virus infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, AIDS virus, etc;
- in addition to hepatitis B, there are other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, serious complications of diabetes and adrenal diseases), immune deficiency diseases, and severe infections; Active or suspected malignant tumor or history of malignant tumor;
- 6 months before enrollment or currently receiving corticosteroids, immunosuppressants and chemotherapeutic drugs;
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 |
|---|---|---|
| PEG-IFNPEG-IFN 180 or 135 micrograms, subcutaneously injected once a week, with a personalized treatment course of 24 weeks | Drug | PEG-IFN optimized treatment group |
Primary outcome
Incidence of HCC during the project study
Time frame: 48 weeks
In the intervention treatment of the above Na treated patients with hypoviremia, the NAS treatment patients who did not have the disappearance of HBsAg have been maintained for a long time, and long-term treatment and follow-up observation are still carried out after the end of the project. For patients treated with NAS combined with PEG-IFN, if HBsAg disappears, continue the treatment after HBsAg disappears, and stop all drug treatment after 12-24 weeks. For the patients who have not lost HBsAg after PEG-IFN combined with NAS treatment, the researcher shall decide whether to stop all drug treatment or stop PEG-IFN treatment and continue NAS maintenance treatment according to the treatment response.
5 secondary outcomes
The negative conversion rate of HBV DNA after 48 weeks of treatment was optimized (below the detection line of highly sensitive detection reagent)
Time frame: 48 weeks
The incidence of HBsAg disappearance during the study period;
Time frame: 48 weeks
HBeAg seroconversion rate in HBeAg positive patients;
Time frame: 48 weeks
Incidence of chronic hepatitis B during the study period
Time frame: 48 weeks
To study the incidence of complications such as cirrhotic ascites and upper gastrointestinal bleeding during long-term follow-up.
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Beijing Ditan 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 5 inclusion and 14 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 12 May 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yao XIe, Doctor (8610-84322200, xieyao00120184@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HCC during the project study (time frame: 48 weeks). 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 12 May 2022.