chronic hepatitis B
Conditions
Interventions
adolescents (aged 12 to < 18 years) with chronic hepatitis B:tenofovir alafenamide
Sponsors
The third hosptial of zhenjiang affiliated jiangsu university
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent (for children and parents/legal guardians); 2. Male or non pregnant, non lactating female, aged 12 to 18 years; 3. Documented evidence of chronic hepatitis B (such as HBsAg positivity>=6 months); 4. The subjects must be able to follow the medication instructions for the study administration and be able to complete the evaluated study schedule.
Exclusion criteria
Exclusion criteria: 1. Men and women with reproductive potential who are unwilling to use "effective" and agreed contraceptive methods during the research period; 2. Clinical major diseases (except chronic hepatitis B) or any other major medical diseases that the researchers think may interfere with the treatment, evaluation or compliance of the subject; 3. Gastrointestinal disorders or postoperative conditions that may interfere with absorption (for example, gastric bypass surgery or severe ulcerative colitis); 4. Difficulty in blood collection and/or poor venous access; 5. Within the past 2 years, hospitalization due to mental illness, attempted suicide, and/or disability for a period of time. Patients with mental disorders who have been well controlled in a stable treatment plan for at least 12 months before screening, or those who have not required medication in the past 12 months, can be included; 6. Severe drug allergy (such as allergic reaction or hepatotoxicity); 7. Clinically related drug or alcohol abuse within 12 months after screening, including any uncontrolled drug use within 6 months after screening. Positive drug screening will exclude subjects unless they can be explained with prescription drugs; Diagnosis and prescription must be approved by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA;ALT;HBsAg;HBeAg;Renal function;Determination of inorganic phosphorus and calcium;Blood Lipid determination; | — |
Countries
China
Contacts
Public ContactTan Youwen
The third hosptial of zhenjiang affiliated jiangsu university
Outcome results
None listed