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

Last updated: September 19, 2023
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis B

Liver Disorders

Hepatitis

Treatment

TMF

Clinical Study ID

NCT05755776
HS-10234-A005
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be able to understand and sign a written informed consent, which must be obtainedprior to screening.
  2. Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65years (based on the date of signed informed consent). Female subjects of childbearingage with a negative serum pregnancy test.
  3. Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6months.
  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 andcontinuous low-level viraeima).
  6. Must be willing and able to comply with all study requirements.

Exclusion

Exclusion Criteria:

  1. Female patients who are pregnant or breastfeeding or who plan to become pregnantduring the study period.
  2. Men and women of childbearing potential who are unwilling to use an "effective" methodof 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 hepatocellularcarcinoma)
  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 tumorscured by surgical resection (basal cell dermal skin cancer, etc.); patients evaluatedfor probable malignancy were ineligible.
  7. Currently receiving treatment with immunomodulators (e.g., corticosteroids),investigational drugs, nephrotoxic drugs, or drugs capable of regulating renalexcretion. Drugs that modulate renal excretion.
  8. Renal, cardiovascular, pulmonary, or neurological disease that is considered severe bythe investigator.
  9. Severe bone disease (e.g., osteochondrosis, chronic osteomyelitis, osteogenesisimperfecta, chondromalacia) or multiple fractures.
  10. Subjects receiving a contraindicated combination drug (subjects receiving acontraindicated drug require a minimum 30-day washout period) and knownhypersensitivity reactions to study drugs, metabolites or formulation excipients.
  11. Current alcohol or drug abuse that, in the investigator's judgment, may interfere withthe subject's compliance with study requirements.
  12. Any other clinical condition that, in the opinion of the investigator, would renderthe subject unsuitable for the study or unable to comply with the dosing requirementsmedical condition or prior treatment.
  13. Prior or existing clinical liver failure (Child-Pugh score ≥ grade B).

Study Design

Total Participants: 204
Treatment Group(s): 1
Primary Treatment: TMF
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400010
    China

    Active - Recruiting

  • Chongqing University Three Gorges Central Hospital

    Chongqing, 400010
    China

    Site Not Available

  • Affiliated Hospital of Guangxi Medical University

    Guangxi,
    China

    Site Not Available

  • Guizhou Provincial People's Hospital

    Guiyang,
    China

    Site Not Available

  • Hepatobiliary disease of Jilin Province

    Jilin,
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming,
    China

    Site Not Available

  • the Second People's Hospital of Yunnan Province

    Kunming,
    China

    Site Not Available

  • Nanjing Second Hospital

    Nanjing,
    China

    Site Not Available

  • The Second Hospital of Ningbo

    Ningbo,
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shuguang Hospital, Shanghai, China.

    Shanghai,
    China

    Site Not Available

  • The Sixth People's Hospital of Shenyang

    Shenyang,
    China

    Site Not Available

  • Shijiazhuang Fifth Hospital

    Shijiazhuang,
    China

    Site Not Available

  • The First People's Hospital of Taicang

    Taicang,
    China

    Site Not Available

  • The Fourth People's Hospital of Zibo

    Zibo,
    China

    Site Not Available

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