Genotype 1 chronic hepatitis C
Conditions
Interventions
Emitasvir phosphate+sofosbuvir:None
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions can enter this study. 1. Age>=18 years old, gender not limited; 2. Clinically diagnosed as chronic hepatitis C: HCV infection has lasted for more than 6 months, or there is an epidemiological history before 6 months, or the date of infection is unknown. Anti-HCV and HCV RNA are positive during screening, and liver histopathological examination is consistent with chronic hepatitis. Or a diagnosis can also be made based on a comprehensive analysis of symptoms, signs, laboratory and imaging examination results; 3. HCV genotype 1 infection (including genotype 1a, genotype 1b, and mixed genotype 1a/1b); 4. The doctor plans to prescribe emitasvir phosphate capsules combined with sofosbuvir tablets; 5. Voluntarily participate in the research and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions are not eligible to enter this study. 1. Previously used direct antiviral agents for treatment; 2. Patients with stage 4-5 chronic kidney disease (eGFR< 30mL/min/1.73m2); 3. Patients with decompensated liver cirrhosis; 4. Patients with malignant tumors; 5. Pregnant or lactating women; 6. Have a history of drug abuse; 7. Currently participating in other interventional clinical trials; 8. Other circumstances where the researcher deems it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained Virological Response 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with HCV RNA< LLOQ at the end of treatment;The changes of the Five-Level EuroQol Five-Dimensional Questionnaire compared with the baseline;Incidence of adverse events;Incidence of serious adverse events;The incidence of serious adverse events related to drugs;The newly added safety information of emitasvir phosphate capsules compared with the pre-market study; | — |
Countries
China
Contacts
Public ContactRongmeng Jiang
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed