Chronic Hepatitis BNCT03366571
Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
An observational study of Chronic Hepatitis B, run by Beijing Friendship Hospital at 4 sites in China.
Trial summary
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Nucleos(t)ide Analogues
- How many people
- 600 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2016to Dec 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The HBV-related chronic hepatitis /cirrhosis patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research.
Who may be able to join
- Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
- Patients comply with the requirements of the trail voluntarily
- Written informed consent
Who cannot join
- Pregnant woman or patient with severe disease
- Patients with poor adherence to the study
- Patients not suitable for the study evaluated by the investigator
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Ditan Hospital
Beijing, Beijing Municipality
Beijing YouAn Hospital
Beijing, Beijing Municipality
Peking University People's Hopsital
Beijing, Beijing Municipality
About this study
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.
Read the detailed description
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.
- Conditions
- Chronic Hepatitis B
- Being tested
- Nucleos(t)ide Analogues
- Keywords
- Liver Cirrhosis
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleos(t)ide AnaloguesDrug
Also called Baraclude , et al
Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.
| Study group | Role | What they receive |
|---|---|---|
| Anti-viral therapy group | Subjects who have completed the 3 years research "Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis" Receives: Drug: Nucleos(t)ide Analogues | |
| Non anti-viral therapy group | History study from literature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death
Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment
Measured: 10 years
Secondary outcomes (8)
HBV-DNA undetectable rate
HBV-DNA undetectable rate after 10 years of antiviral treatment
Measured: 10 years
Decrease of transient elastography
Decrease of transient elastography after 10 years of antiviral treatment
Measured: 10 years
HBeAg seroconversion rate
HBeAg seroconversion rate after 10 years of antiviral treatment
Measured: 10 years
HBsAg seroconversion rate
HBsAg seroconversion rate after 10 years of antiviral treatment
Measured: 10 years
Decrease of Child-Pugh score
Decrease of Child-Pugh score after 10 years of antiviral treatment
Measured: 10 years
Decrease of MELD score
Decrease of MELD score after 10 years of antiviral treatment
Measured: 10 years
Improvement of life Quality assessed by SF-36
Improvement of life Quality assessed by SF-36 after 10 years of antiviral treatment
Measured: 10 years
Improvement of life Quality assessed by EQ-5D
Improvement of life Quality assessed by EQ-5D after 10 years of antiviral treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startJan 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Beijing YouAn Hospital, Beijing Ditan Hospital
- Responsible party
- Principal investigator, Jidong Jia, Beijing Friendship Hospital
- Investigators
- Dong J Jia, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366571
- Sponsor's protocol ID
- D161100002716003
- Status last verified
- Apr 2021
- First submitted
- 29 Jul 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.
PubMed 33460002
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03366571
- Acronym / sponsor ID
- D161100002716003
- Conditions
- Chronic Hepatitis B
- Keywords
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Beijing YouAn Hospital, Beijing Ditan Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Dec 2017 (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.
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.
Detailed description
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-viral therapy group | – | Drug: Nucleos(t)ide AnaloguesSubjects who have completed the 3 years research "Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis" |
| Non anti-viral therapy group | – | –History study from literature |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The HBV-related chronic hepatitis /cirrhosis patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research.
Key inclusion criteria (3 listed)
- Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
- Patients comply with the requirements of the trail voluntarily
- Written informed consent
Key exclusion criteria (3 listed)
- Pregnant woman or patient with severe disease
- Patients with poor adherence to the study
- Patients not suitable for the study evaluated by the investigator
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 |
|---|---|---|
| Nucleos(t)ide AnaloguesAlso: Baraclude , et alEntecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily. | Drug | Anti-viral therapy group |
Primary outcome
Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death
Time frame: 10 years
Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment
8 secondary outcomes
HBV-DNA undetectable rate
Time frame: 10 years
Decrease of transient elastography
Time frame: 10 years
HBeAg seroconversion rate
Time frame: 10 years
HBsAg seroconversion rate
Time frame: 10 years
Decrease of Child-Pugh score
Time frame: 10 years
Decrease of MELD score
Time frame: 10 years
Improvement of life Quality assessed by SF-36
Time frame: 10 years
Improvement of life Quality assessed by EQ-5D
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 33460002Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.
- Individual participant dataSharing planned: Undecided
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Chronic Hepatitis B
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.
Dong J Jia, Doctor principal investigator
Beijing Friendship Hospital
4 sites 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 Friendship Hospital at 4 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 3 inclusion and 3 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
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?
Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03366571, which also lists 1 linked publication.
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 14 Apr 2021.