Clinical Characteristics, Natural Outcome and Treatment Optimization of Refractory

NCT ID: NCT05376124

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Refractory sex hepatitis B is to point to although standard application nucleoside (acid) analogue treatment undertakes first treat and 2 strengthen treat cure, but existence is persistent viraemia. These patients have active liver inflammation and are at high risk for progression to cirrhosis or primary liver cancer due to persistent virus-positive symptoms. Therefore, it is of great significance to find an effective antiviral program for refractory hepatitis B to reduce the fatality rate of hepatitis B in China. At present, the guidelines recommend that patients with drug resistance to Entecavir (ETV) be treated with tenofovir fumarate (TDF) or propofol tenofovir fumarate (TAF), and clinical studies in China have confirmed that increased dosage of entecavir to 1.0mg can be used as the treatment of drug resistance to entecavir. TDF and TAF resistant patients can be treated with entecavir 0.5mg. However, currently there is no consensus on salvage treatment for patients who remain virus-positive after a second round of antiviral therapy. Previous studies have shown that TDF/TAF combined with ETV 1.0mg as a rescue regimen has no obvious adverse drug reactions. This is the first multicenter, prospective, parallel controlled, open-label cohort study to compare the efficacy and safety of TDF/TAF combined with ETV 1.0mg regimen versus continuation of the original regimen in the treatment of refractory hepatitis B. Meanwhile, long-term outcomes of refractory hepatitis B patients, such as survival, cirrhosis and primary liver cancer, were observed. In addition, the effects of refractory hepatitis B virus strain, host and other clinical characteristics on the antiviral efficacy of nucleoside (acid) analogue were compared with those of patients with initial treatment and secondary enhancement of nucleoside (acid) analogue response. The results of this study are expected to provide a new perspective for the treatment of refractory hepatitis B and provide direct evidence for the formulation of guidelines for the diagnosis and treatment of chronic hepatitis B in China and even internationally.

Conditions

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Hepatitis B, Chronic Virus Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

original therapy

Intervention Type OTHER

* 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

rescue therapy

TDF 300mg/ day +ETV 1.0mg/ day or TAF 25mg/ day +ETV 1.0mg/ day, oral treatment for 48 weeks.

rescue therapy

Intervention Type OTHER

TDF 300mg/ day +ETV 1.0mg/ day or TAF 25mg/ day +ETV 1.0mg/ day, oral treatment for 48 weeks.

Interventions

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original therapy

* 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

Intervention Type OTHER

rescue therapy

TDF 300mg/ day +ETV 1.0mg/ day or TAF 25mg/ day +ETV 1.0mg/ day, oral treatment for 48 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingren Zhao

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University

Locations

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Ankang Central Hospital

Ankang, , China

Site Status RECRUITING

Hanzhong 3201 Hospital

Hanzhong, , China

Site Status RECRUITING

Qianfhan Hospital

Jinan, , China

Site Status RECRUITING

Weinan Central Hospital

Weinan, , China

Site Status RECRUITING

Wuhan Union Hospital

Wuhan, , China

Site Status RECRUITING

Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status RECRUITING

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, , China

Site Status RECRUITING

Tang-Du Hospital

Xi'an, , China

Site Status RECRUITING

Xi'an Central Hospital

Xi'an, , China

Site Status RECRUITING

Xijing hospital of air force Medical University

Xi'an, , China

Site Status RECRUITING

Yan'an University Affiliated Hospital

Yan’an, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingren Zhao

Role: CONTACT

18691232863

Yushan Liu

Role: CONTACT

15102901360

Facility Contacts

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Kui Li

Role: primary

13571422201

Yongmei Lin

Role: primary

13109188835

Hongbin Li

Role: primary

13468902958

Yingli He

Role: primary

18991232863

Nan Yang

Role: backup

13572227780

Fanpu Ji

Role: primary

15319435860

Hong Du

Role: primary

Other Identifiers

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XJTU1AF2021CRF-006

Identifier Type: -

Identifier Source: org_study_id

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