Clinical Characteristics, Natural Outcome and Treatment Optimization of Refractory
1 other identifier
observational
110
1 country
13
Brief Summary
Refractory hepatitis B is to point to although standard application nucleoside (acid) analogue treatment undertakes primary treatment and two strengthen treatment, but existence is persistent viremia. Currently, there is no consensus on salvage therapy for patients who remain virus-positive after a second round of antiviral therapy. This is the first multicenter, prospective, parallel controlled, open-label cohort study to compare the efficacy and safety of TDF/TAF combined with ETV1.0mg regimen versus continuation of the original regimen in the treatment of refractory hepatitis B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 3, 2023
October 1, 2022
3 years
May 11, 2022
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Negative HBV-DNA conversion
Negative HBV-DNA conversion at 48 weeks of treatment
48weeks
Liver hardness measurement
3-year liver hardness measurement (LSM value)
3 years
Hepatocellular carcinoma
Incidence and survival of hepatocellular carcinoma.
3 years
Secondary Outcomes (4)
virology indicators
48weeks
Biochemical indexes
3 years
Immunological indicators
3 years
Drug-related adverse reactions
3 years
Other Outcomes (1)
Strain mutation indicators
1year,2years and 3years
Study Arms (2)
original therapy
ETV 0.5mg/ day or TDF 300mg/ day or TAF 25mg/ day continued the original regimen (ETV 1.0mg/ day or TDF 300mg/ day or TAF 25mg/ day), Oral treatment lasted 48 weeks ②TDF 300mg/ day plus ETV 0.5mg/ day on initial treatment continued with the original regimen (TDF 300mg/ day plus ETV 0.5mg/ day) and oral therapy for 48 weeks ③TAF 25mg/ day plus ETV 0.5mg/ day as initial treatment continued the original regimen (TAF 25mg/ day plus ETV 0.5mg/ day) for 48 weeks of oral therapy
rescue therapy
TDF 300mg/ day +ETV 1.0mg/ day or TAF 25mg/ day +ETV 1.0mg/ day, oral treatment for 48 weeks.
Interventions
* Patients on ETV 0.5mg/ day or TDF 300mg/ day or TAF 25mg/ day continued the original regimen (ETV 1.0mg/ day or TDF 300mg/ day or TAF 25mg/ day), Oral treatment lasted 48 weeks ②Patients who received TDF 300mg/ day plus ETV 0.5mg/ day on initial treatment continued with the original regimen (TDF 300mg/ day plus ETV 0.5mg/ day) and oral therapy for 48 weeks ③Patients who received TAF 25mg/ day plus ETV 0.5mg/ day as initial treatment continued the original regimen (TAF 25mg/ day plus ETV 0.5mg/ day) for 48 weeks of oral therapy
TDF 300mg/ day +ETV 1.0mg/ day or TAF 25mg/ day +ETV 1.0mg/ day, oral treatment for 48 weeks.
Eligibility Criteria
Patients with refractory hepatitis B in January 2022 to January 2023 of The First Affiliated Hospital of Xi 'an Jiaotong University、The Second Affiliated Hospital of Xi 'an Jiaotong University、 Xijing Hospital Air Force Medical University 、Tang-du Hospital 、Shaanxi Provincial People's Hospital Xi 'an Central Hospital、 Ankang Central Hospital 、Yan 'an University Affiliated Hospital、 Hanzhong 3201 Hospital Weinan Central Hospital 、The First Affiliated Hospital of Shandong Medical University、Wuhan Union Hospital、The First Affiliated Hospital of Zhengzhou University. All patients were required to sign written informed consent before enrollment
You may qualify if:
- (1) The diagnostic criteria of chronic hepatitis B: HBsAg and/or HBV DNA positive for more than 6 months; (2) Conforming to the definition of refractory hepatitis B (3) Aged between 18 and 70 (including 18 and 70); (4) Willing to accept treatment and sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Ankang Central Hospital
Ankang, China
Hanzhong 3201 Hospital
Hanzhong, China
Qianfhan Hospital
Jinan, China
Weinan Central Hospital
Weinan, China
Wuhan Union Hospital
Wuhan, China
Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Shaanxi Provincial People's Hospital
Xi'an, China
Tang-Du Hospital
Xi'an, China
Xi'an Central Hospital
Xi'an, China
Xijing hospital of air force Medical University
Xi'an, China
Yan'an University Affiliated Hospital
Yan’an, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingren Zhao
Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 17, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
February 3, 2023
Record last verified: 2022-10