Clinical Characteristics, Natural Outcome and Treatment Optimization of Refractory

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · May 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with chronic hepatitis B who have not responded to standard antiviral therapies. The researchers want to compare the effectiveness and safety of a combination treatment (TDF/TAF with ETV) to continuing the original treatment that hasn't worked. This trial is important because many patients still have the virus in their bodies even after receiving multiple rounds of treatment, and there is currently no agreed-upon method for helping these patients.

To be eligible for this trial, participants need to be between 18 and 70 years old and have been diagnosed with chronic hepatitis B for at least six months. They should also be willing to participate and provide informed consent. However, certain individuals, such as those who are pregnant, have other active infections, or serious health conditions affecting their liver or mental health, will not be able to join. If someone participates in this trial, they can expect to receive either the new combination treatment or continue with their current regimen, along with regular check-ups to monitor their health. This trial is currently recruiting participants, so eligible patients have the opportunity to contribute to important research that could lead to better treatments for chronic hepatitis B.

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Eligibility criteria

• 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.
• Exclusion Criteria:
• • (1) Pregnant women or lactating women; (2) with active HEPATITIS A, hepatitis C, and hepatitis D (in hospitals where conditions permit), hepatitis E and/or HIV infection; (3) Decompensated cirrhosis (Child-Pugh score 6); (4) Symptoms and signs of hepatocellular carcinoma, AFP\> Patients with 100ng/ml of AFP would be excluded, but patients whose AFP remained stable (increased by less than 10%) for more than 3 months prior to the trial could be enrolled in patients whose liver tumors were excluded by liver imaging if AFP\> 20ng/mL but 100ng/mL can be selected; (5) In addition to viral hepatitis, other history or evidence related to chronic liver disease (such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure, thalassemia); (6) a history of serious mental illness, especially depression severe mental illness is defined as at least 3 months before the above treatment dose antidepressant or antipsychotic drug treatment of severe depression or psychosis, or there are any medical history: once for attempted suicide was hospitalized due to mental illness, or had a disability due to mental illness; (7) a history of severe seizures or current use of anticonvulsants; (8) a history of chronic lung disease related to functional limitations; (9) A history of severe heart disease (NYHA grade III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring continued treatment, unstable angina or other important cardiovascular disease); (10) patients who are participating in other trials or have been treated with the study drug in the 12 weeks prior to screening; (11) Patients with a history of allergy to ETV, TDF and TAF; In addition to the above exclusion criteria, patients who meet any of the contraindications in the experimental drug description; (12) Unable or unwilling to provide informed consent or comply with the requirements of the study.