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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05086536
Other study ID # 2021-P2-224-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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