Hepatitis BNCT05086536
Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
An observational study of Hepatitis B and Decompensated Cirrhosis, run by Beijing Friendship Hospital at 7 sites in China.
Trial summary
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Decompensated Cirrhosis
- How many people
- 600 participants
- Where
- 7 sitesChina
- Study dates
- 15 Oct 2021to 30 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HBV-decompensated cirrhosis patients who occurred first decompensated events and initiated antiviral therapy within 3 months.
Who may be able to join
- Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
- Initiating antiviral therapy within 3 months of the first decompensated events;
- Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
- Clinical outcomes were classified:
- Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
- With ≥ 2 episodes of decompensation: medical records for decompensation were available.
Who cannot join
- Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
- Liver transplantation /death within 6 months of first decompensated events;
- complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
- Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
- Pregnant women.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The Second Affiliated Hospital of Baotou Medical Coll
Baotou, Inner Mongolia
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Xiaoning Wu, Doctor, 8610-63138665, wuxiaoningbs@126.com
Zhiying He, 13311314386, zhiyinghe2012@126.com
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 10069
Jie Chen, Doctor, 13810594713, jiechenokcat0215@126.com
Zhongjie Hu
XiangYa Hospital Central South University
Changsha, Hunan, 410011
Yixiang Zheng, Doctor, 15111002627, 418414718@qq.com
Yan Huang, Doctor
Shandong Provincial Hospital
Jinan, Shandong, 250021
Lianhui Zhao, Doctor, 18810825004, 18253163004@163.com
Chunqing Zhang, Docote
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Qiuju Tian, Doctor, 18610827822, tianqiuju_1017@163.com
Wei Rao, Docotr
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Yanqin Hao, Doctor, 13994262902, 13994262902@163.com
Yanqin Hao, Doctor
About this study
Official title: Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.
Read the detailed description
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.
- Conditions
- Hepatitis B, Decompensated Cirrhosis
- Being tested
- no intervention
- Keywords
- re-compensation, treatment-naive, HBV, decompensation
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is a retrospective and observational study.
| Study group | Role | What they receive |
|---|---|---|
| early stage decompensation cohort | Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of re-compensation
Patients who did not occur further decompensation
Measured: Year 5
Secondary outcomes (9)
Cumulative incidence of re-compensation
Patients who did not occur further decompensation
Measured: Year 1, 2, 3, and 4
Annual incidence of second decompensation
Patients who occurred second decompensation
Measured: Year 1, 2, 3, 4, and 5
Cumulative incidence of liver-related death / liver transplantation
Patients who died of decompensation
Measured: Year 1, 2, 3, 4, and 5
Cumulative incidence of HCC
Patients who occurred HCC
Measured: Year 1, 2, 3, 4, and 5
Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group
Child-Pugh
Measured: Year 1, 2, 3, 4, and 5
Dynamic changes of MELD score in re-compensated and not re-compensated group
MELD
Measured: Year 1, 2, 3, 4, and 5
Dynamic changes of APRI score in re-compensated and not re-compensated group
APRI
Measured: Year 1, 2, 3, 4, and 5
Dynamic changes of FIB-4 score in re-compensated and not re-compensated group
FIB-4
Measured: Year 1, 2, 3, 4, and 5
Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group
Liver stiffness
Measured: Year 1, 2, 3, 4, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start15 Oct 2021 (estimated)
- Primary completion1 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing YouAn Hospital, Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Shanxi Medical University, Xiangya Hospital of Central South University, The Second Affiliated Hospital of Baotou Medical College
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, Doctor, Principal investigator, Beijing Friendship Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086536
- Sponsor's protocol ID
- 2021-P2-224-01
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jang JW, Choi JY, Kim YS, Woo HY, Choi SK, Lee CH, Kim TY, Sohn JH, Tak WY, Han KH. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Hepatology. 2015 Jun;61(6):1809-20. doi: 10.1002/hep.27723. Epub 2015 Mar 18.
PubMed 25627342Belli LS, Berenguer M, Cortesi PA, Strazzabosco M, Rockenschaub SR, Martini S, Morelli C, Donato F, Volpes R, Pageaux GP, Coilly A, Fagiuoli S, Amaddeo G, Perricone G, Vinaixa C, Berlakovich G, Facchetti R, Polak W, Muiesan P, Duvoux C; European Liver and Intestine Association (ELITA). Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study. J Hepatol. 2016 Sep;65(3):524-31. doi: 10.1016/j.jhep.2016.05.010. Epub 2016 May 17.
PubMed 27212241Pascasio JM, Vinaixa C, Ferrer MT, Colmenero J, Rubin A, Castells L, Manzano ML, Lorente S, Testillano M, Xiol X, Molina E, Gonzalez-Dieguez L, Oton E, Pascual S, Santos B, Herrero JI, Salcedo M, Montero JL, Sanchez-Antolin G, Narvaez I, Nogueras F, Giraldez A, Prieto M, Forns X, Londono MC. Clinical outcomes of patients undergoing antiviral therapy while awaiting liver transplantation. J Hepatol. 2017 Dec;67(6):1168-1176. doi: 10.1016/j.jhep.2017.08.008. Epub 2017 Aug 24.
PubMed 28842296Perricone G, Duvoux C, Berenguer M, Cortesi PA, Vinaixa C, Facchetti R, Mazzarelli C, Rockenschaub SR, Martini S, Morelli C, Monico S, Volpes R, Pageaux GP, Fagiuoli S, Belli LS; European Liver and Intestine Transplant Association (ELITA). Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting. Liver Int. 2018 Dec;38(12):2170-2177. doi: 10.1111/liv.13878. Epub 2018 May 25.
PubMed 29750389
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy
- ClinicalTrials.gov ID
- NCT05086536
- Acronym / sponsor ID
- 2021-P2-224-01
- Conditions
- Hepatitis B, Decompensated Cirrhosis
- Keywords
- re-compensation, treatment-naive, HBV, decompensation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing YouAn Hospital, Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Shanxi Medical University, Xiangya Hospital of Central South University, The Second Affiliated Hospital of Baotou Medical College
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Oct 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.
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.
Detailed description
In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early stage decompensation cohort | – | Other: no interventionPatients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HBV-decompensated cirrhosis patients who occurred first decompensated events and initiated antiviral therapy within 3 months.
Key inclusion criteria (6 listed)
- Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
- Initiating antiviral therapy within 3 months of the first decompensated events;
- Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
- Clinical outcomes were classified:
Key exclusion criteria (5 listed)
- Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
- Liver transplantation /death within 6 months of first decompensated events;
- complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
- Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
- Pregnant women.
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 |
|---|---|---|
| no interventionThis is a retrospective and observational study. | Other | early stage decompensation cohort |
Primary outcome
Cumulative incidence of re-compensation
Time frame: Year 5
Patients who did not occur further decompensation
9 secondary outcomes
Cumulative incidence of re-compensation
Time frame: Year 1, 2, 3, and 4
Annual incidence of second decompensation
Time frame: Year 1, 2, 3, 4, and 5
Cumulative incidence of liver-related death / liver transplantation
Time frame: Year 1, 2, 3, 4, and 5
Cumulative incidence of HCC
Time frame: Year 1, 2, 3, 4, and 5
Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group
Time frame: Year 1, 2, 3, 4, and 5
Dynamic changes of MELD score in re-compensated and not re-compensated group
Time frame: Year 1, 2, 3, 4, and 5
Dynamic changes of APRI score in re-compensated and not re-compensated group
Time frame: Year 1, 2, 3, 4, and 5
Dynamic changes of FIB-4 score in re-compensated and not re-compensated group
Time frame: Year 1, 2, 3, 4, and 5
Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group
Time frame: Year 1, 2, 3, 4, and 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 25627342Jang JW, Choi JY, Kim YS, Woo HY, Choi SK, Lee CH, Kim TY, Sohn JH, Tak WY, Han KH. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Hepatology. 2015 Jun;61(6):1809-20. doi: 10.1002/hep.27723. Epub 2015 Mar 18.
- Background: PubMed 27212241Belli LS, Berenguer M, Cortesi PA, Strazzabosco M, Rockenschaub SR, Martini S, Morelli C, Donato F, Volpes R, Pageaux GP, Coilly A, Fagiuoli S, Amaddeo G, Perricone G, Vinaixa C, Berlakovich G, Facchetti R, Polak W, Muiesan P, Duvoux C; European Liver and Intestine Association (ELITA). Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study. J Hepatol. 2016 Sep;65(3):524-31. doi: 10.1016/j.jhep.2016.05.010. Epub 2016 May 17.
- Background: PubMed 28842296Pascasio JM, Vinaixa C, Ferrer MT, Colmenero J, Rubin A, Castells L, Manzano ML, Lorente S, Testillano M, Xiol X, Molina E, Gonzalez-Dieguez L, Oton E, Pascual S, Santos B, Herrero JI, Salcedo M, Montero JL, Sanchez-Antolin G, Narvaez I, Nogueras F, Giraldez A, Prieto M, Forns X, Londono MC. Clinical outcomes of patients undergoing antiviral therapy while awaiting liver transplantation. J Hepatol. 2017 Dec;67(6):1168-1176. doi: 10.1016/j.jhep.2017.08.008. Epub 2017 Aug 24.
- Background: PubMed 29750389Perricone G, Duvoux C, Berenguer M, Cortesi PA, Vinaixa C, Facchetti R, Mazzarelli C, Rockenschaub SR, Martini S, Morelli C, Monico S, Volpes R, Pageaux GP, Fagiuoli S, Belli LS; European Liver and Intestine Transplant Association (ELITA). Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting. Liver Int. 2018 Dec;38(12):2170-2177. doi: 10.1111/liv.13878. Epub 2018 May 25.
- Individual participant dataSharing planned: Undecided
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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.
Hong You, Doctor principal investigator
Beijing Friendship Hospita
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Decompensated Cirrhosis, run by Beijing Friendship Hospital at 7 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 6 inclusion and 5 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Contact Hong You, Doctor (861063139019, youhong30@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of re-compensation (time frame: Year 5). 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 NCT05086536, which also lists 4 linked publications.
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 21 Oct 2021.