Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

Hepatitis B Clinical Trial

Official title:

Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05086536
• Other study ID #: 2021-P2-224-01
• Status: Not yet recruiting
• Start date: October 15, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2021
• Source: Beijing Friendship Hospital
• Contact: Hong You, Doctor
• Phone: 861063139019
• Email: youhong30[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Hepatitis B
• Liver Cirrhosis

Intervention

Other:
• no intervention
This is a retrospective and observational study.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Baotou Medical Coll	Baotou	Inner Mongolia
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing
China	XiangYa Hospital Central South University	Changsha	Hunan
China	Shandong Provincial Hospital	Jinan	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (7)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing YouAn Hospital, Shandong Provincial Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Shanxi Medical University, The Second Affiliated Hospital of Baotou Medical College, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View Citation

Pascasio JM, Vinaixa C, Ferrer MT, Colmenero J, Rubin A, Castells L, Manzano ML, Lorente S, Testillano M, Xiol X, Molina E, González-Diéguez L, Otón E, Pascual S, Santos B, Herrero JI, Salcedo M, Montero JL, Sánchez-Antolín G, Narváez I, Nogueras F, Giráldez Á, Prieto M, Forns X, Londoño 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of re-compensation	Patients who did not occur further decompensation	Year 5
Secondary	Cumulative incidence of re-compensation	Patients who did not occur further decompensation	Year 1, 2, 3, and 4
Secondary	Annual incidence of second decompensation	Patients who occurred second decompensation	Year 1, 2, 3, 4, and 5
Secondary	Cumulative incidence of liver-related death / liver transplantation	Patients who died of decompensation	Year 1, 2, 3, 4, and 5
Secondary	Cumulative incidence of HCC	Patients who occurred HCC	Year 1, 2, 3, 4, and 5
Secondary	Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group	Child-Pugh	Year 1, 2, 3, 4, and 5
Secondary	Dynamic changes of MELD score in re-compensated and not re-compensated group	MELD	Year 1, 2, 3, 4, and 5
Secondary	Dynamic changes of APRI score in re-compensated and not re-compensated group	APRI	Year 1, 2, 3, 4, and 5
Secondary	Dynamic changes of FIB-4 score in re-compensated and not re-compensated group	FIB-4	Year 1, 2, 3, 4, and 5
Secondary	Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group	Liver stiffness	Year 1, 2, 3, 4, and 5