Treatment options for patients with refractory hepatitis B
Clinical Characteristics, Natural Outcome and Treatment Optimization of Refractory Hepatitis B: a Open Label, Prospective, Multi-center Cohort Study
This study is testing if a new combination of hepatitis B medications can help patients who aren't getting better with their current treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 13 sites (Ankang and 12 other locations) |
| Trial ID | NCT05376124 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical characteristics and natural outcomes of patients with refractory hepatitis B, who continue to test positive for the virus despite standard antiviral treatments. It will compare the efficacy and safety of a combination therapy of tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) with entecavir (ETV) against the continuation of the original treatment regimen. The study is multicenter and prospective, involving multiple hospitals to gather comprehensive data on treatment outcomes. The goal is to establish a more effective treatment protocol for patients who do not respond to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic hepatitis B who have not responded to standard antiviral treatments.
Not a fit: Patients with active infections of other hepatitis viruses, decompensated cirrhosis, or hepatocellular carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with refractory hepatitis B.
How similar studies have performed: Previous studies have shown promise in using combination therapies for hepatitis B, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ankang and 12 other locations
- Ankang Central Hospital — Ankang, China (Recruiting)
- Hanzhong 3201 Hospital — Hanzhong, China (Recruiting)
- Qianfhan Hospital — Jinan, China (Recruiting)
- Weinan Central Hospital — Weinan, China (Recruiting)
- Wuhan Union Hospital — Wuhan, China (Recruiting)
- Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
- Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
- Shaanxi Provincial People's Hospital — Xi'an, China (Recruiting)
- Tang-Du Hospital — Xi'an, China (Recruiting)
- Xi'an Central Hospital — Xi'an, China (Recruiting)
- Xijing hospital of air force Medical University — Xi'an, China (Recruiting)
- Yan'an University Affiliated Hospital — Yan'an, China (Recruiting)
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)
Study contacts
- Principal investigator: Yingren Zhao — Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University
- Study coordinator: Yingren Zhao
- Email: zhaoyingren@sohu.com
- Phone: 18691232863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.