Hepatopathy
Conditions
Interventions
Case series:Vemlidy treatment regimen
Sponsors
Nanfang Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients (aged 12 years and older with body weights of at least 35 kg) who are Chinese and living in China; 2. Patients with chronic HBV infection eligible for treatment with Vemlidy as indicated in the approved prescribing information in China; 3. Patients who have been informed of all pertinent aspects of the study and have voluntarily signed an informed consent form (patients under 18 years of age must also have signed consent from a legal guardian who has been informed of all pertinent aspects of the study).
Exclusion criteria
Exclusion criteria: 1. Patients treated with Vemlidy outside of the approved prescribing information in China; 2. Concurrent participation in clinical trial of HBV treatment (except trials not testing investigational medicinal products and based on a purely observational setting); 3. Patients who have a contraindication as indicated under Vemlidy prescribing information in China; 4. Patients planning on leaving the country during the study period; 5. Patients deemed by the investigator to be unlikely to maintain regular medical follow-up through at least 48 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events(AEs) and incidence of special situation report(SSRs) occurring during the study period while on Vemlidy, and within 30 days after the end of the study period or within 30 days after termination of Vemlidy treatment;Virologic success at 48 weeks after initiation of Vemlidy, defined as the proportion of patients with plasma HBV DNA levels below the limit of quantification;Results of HBsAg, HBsAb, HBeAg, HBeAb, ALT before and after Vemlidy treatment. 1. Proportion of subjects with ALT normalization 2. Proportion of subjects with HBsAg or HBeAg loss 3. Proportion of subjects with seroconversion to HBsAb; | — |
Countries
China
Contacts
Public ContactAlan Zhao
Gilead Sciences Shanghai Parmaceutical Technology Co.,Ltd.
Outcome results
None listed