Clinical trial NCT05086536: Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
Official title: Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Decompensated Cirrhosis
Keywords: re-compensation
treatment-naive
HBV
decompensation
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: Shandong Provincial Hospital
name: The Affiliated Hospital of Qingdao University
name: The First Affiliated Hospital of Shanxi Medical University
name: Xiangya Hospital of Central South University
name: The Second Affiliated Hospital of Baotou Medical College
First posted: 2021-10-21
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HBV-decompensated cirrhosis patients who occurred first decompensated events and initiated antiviral therapy within 3 months.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
2. Initiating antiviral therapy within 3 months of the first decompensated events;
3. Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
4. Clinical outcomes were classified:

   1. Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
   2. With ≥ 2 episodes of decompensation: medical records for decompensation were available.

Exclusion Criteria:

1. Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
2. Liver transplantation /death within 6 months of first decompensated events;
3. complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
4. Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
5. Pregnant women.

Primary outcomes:
measure: Cumulative incidence of re-compensation
timeFrame: Year 5
Secondary outcomes:
measure: Cumulative incidence of re-compensation
timeFrame: Year 1, 2, 3, and 4
measure: Annual incidence of second decompensation
timeFrame: Year 1, 2, 3, 4, and 5
measure: Cumulative incidence of liver-related death / liver transplantation
timeFrame: Year 1, 2, 3, 4, and 5
measure: Cumulative incidence of HCC
timeFrame: Year 1, 2, 3, 4, and 5
measure: Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group
timeFrame: Year 1, 2, 3, 4, and 5
measure: Dynamic changes of MELD score in re-compensated and not re-compensated group
timeFrame: Year 1, 2, 3, 4, and 5
measure: Dynamic changes of APRI score in re-compensated and not re-compensated group
timeFrame: Year 1, 2, 3, 4, and 5
measure: Dynamic changes of FIB-4 score in re-compensated and not re-compensated group
timeFrame: Year 1, 2, 3, 4, and 5
measure: Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group
timeFrame: Year 1, 2, 3, 4, and 5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
state: Beijing
city: Changsha
country: China
facility: XiangYa Hospital Central South University
state: Hunan
city: Baotou
country: China
facility: The Second Affiliated Hospital of Baotou Medical Coll
state: Inner Mongolia
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Beijing Friendship Hospita
name: Hong You, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Belli 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.
citation: Pascasio 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.
citation: Perricone 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.