The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment (POWER)

September 19, 2023 updated by: The Second Affiliated Hospital of Chongqing Medical University

To Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in Chronic Hepatitis B (CHB) Patients With Low-level Viraemia (LLV) After Entecavir Treatment

The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is:

  • The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
  • What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia.

Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment.

Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China, 400010
        • Not yet recruiting
        • Chongqing University Three Gorges Central Hospital
        • Contact:
          • Xuan An
      • Guangxi, China
        • Not yet recruiting
        • Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Minghua Su
      • Jilin, China
        • Not yet recruiting
        • Hepatobiliary disease of Jilin Province
        • Contact:
          • Hui Chen
      • Kunming, China
        • Not yet recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:
          • Jiawei Geng
      • Kunming, China
        • Not yet recruiting
        • The Second People's Hospital of Yunnan Province
        • Contact:
          • Hui Li
      • Nanjing, China
        • Not yet recruiting
        • Nanjing Second Hospital
        • Contact:
          • Wei Ye
      • Ningbo, China
        • Recruiting
        • The Second Hospital of Ningbo
        • Contact:
          • Airong HU
      • Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Lihong QU
      • Shanghai, China
        • Not yet recruiting
        • Shuguang Hospital, Shanghai, China.
        • Contact:
          • Xuehua Sun
      • Shenyang, China
        • Not yet recruiting
        • The Sixth People's Hospital of Shenyang
        • Contact:
          • Xiaofeng Wu
      • Taicang, China
        • Not yet recruiting
        • The First People's Hospital of Taicang
        • Contact:
          • Yonglan Pu
      • Zibo, China
        • Not yet recruiting
        • The Fourth People's Hospital Of Zibo
        • Contact:
          • Gang Li
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Peng Hu, PhD
          • Phone Number: +86 13608338064
          • Email: hp_cq@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population was chronic hepatitis B patients with LLV (HBV DNA from 20-to 2000IU/mL) of ETV treatment from multiple centers across mainland China.

Description

Inclusion Criteria:

  1. Must be able to understand and sign a written informed consent, which must be obtained prior to screening.
  2. Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 years (based on the date of signed informed consent). Female subjects of childbearing age with a negative serum pregnancy test.
  3. Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months.
  4. Subjects treated with ETV over 1 year will be able to be enrolled in the study.
  5. Subjects with 20 ≤ HBV-DNA < 2000 IU/mL at screening (including intermittent and continuous low-level viraeima).
  6. Must be willing and able to comply with all study requirements.

Exclusion Criteria:

  1. Female patients who are pregnant or breastfeeding or who plan to become pregnant during the study period.
  2. Men and women of childbearing potential who are unwilling to use an "effective" method of contraception as defined in the protocol during the study period.
  3. Co-infection with HAV HCV, HIV, HDV or HEV; or co-infection with autologous liver, metabolism-related fatty liver, or drug-induced liver injury.
  4. Diagnosis of hepatocellular carcinoma by imaging (with evidence of hepatocellular carcinoma)
  5. Patients who have received a solid organ or bone marrow transplant
  6. History of malignancy within 5 years prior to screening, except for specific tumors cured by surgical resection (basal cell dermal skin cancer, etc.); patients evaluated for probable malignancy were ineligible.
  7. Currently receiving treatment with immunomodulators (e.g., corticosteroids), investigational drugs, nephrotoxic drugs, or drugs capable of regulating renal excretion. Drugs that modulate renal excretion.
  8. Renal, cardiovascular, pulmonary, or neurological disease that is considered severe by the investigator.
  9. Severe bone disease (e.g., osteochondrosis, chronic osteomyelitis, osteogenesis imperfecta, chondromalacia) or multiple fractures.
  10. Subjects receiving a contraindicated combination drug (subjects receiving a contraindicated drug require a minimum 30-day washout period) and known hypersensitivity reactions to study drugs, metabolites or formulation excipients.
  11. Current alcohol or drug abuse that, in the investigator's judgment, may interfere with the subject's compliance with study requirements.
  12. Any other clinical condition that, in the opinion of the investigator, would render the subject unsuitable for the study or unable to comply with the dosing requirements medical condition or prior treatment.
  13. Prior or existing clinical liver failure (Child-Pugh score ≥ grade B).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ETV group
Participants in this group will continue ETV daily until the end of the study.
TMF group
Participants in this group will switch to TMF 25 mg, daily until the end of the study.
Drug: TMF
switch ETV to TMF
Other Names:
  • Heng Mu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48.
Time Frame: 48 weeks
Undetectable HBV DNA is defined as below 20 IU/mL.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 24.
Time Frame: 24 weeks
Undetectable HBV DNA is defined as below 20 IU/mL.
24 weeks
The proportions of ALT normalization in patients treated with ETV and TMF at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
There are two criteria for ALT normalization. Criteria1: below 40 U/L. Criteria2: Males: ALT<30U/L, female: ALT<19U/L.
24 weeks and 48 weeks
Comparing pgRNA levels from baseline at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Comparing HBcrAg levels from baseline at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
The proportions of undetectable pgRNA in patients treated with ETV and TMF at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
Undetectable pgRNA is defined as below 100 pg/mL.
24 weeks and 48 weeks
The proportions of undetectable HBcrAg in patients treated with ETV and TMF at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Comparing degree of liver fibrosis from baseline at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
Evaluation of liver fibrosis including Fibroscan, APRI and FIB-4.
24 weeks and 48 weeks
Comparing the change of creatinine clearance rate from baseline at week 24 and 48.
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
The types, incidence and severity of adverse events and serious adverse events during treatment were evaluated in both groups
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Peng Hu, phD, The Second Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-10234-A005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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