SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China
| Registry | NCT04948801 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 150 (Estimated) |
| Sponsor | Third Affiliated Hospital, Sun Yat-Sen University (Other) |
| Conditions | Hepatitis C |
| Interventions | Epclusa (sofosbuvir and velpatasvir) (Drug) |
| Dates | start 2018-12-08, primary completion 2021-12-01 (estimated), completion 2021-12-30 (estimated), first posted 2021-07-02, last updated 2021-07-02 |
| Locations | 1 site in China |
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All trials for Hepatitis C All trials of Epclusa (sofosbuvir and velpatasvir)
150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.
This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| genotype 3a HCV | Drug: Epclusa (sofosbuvir and velpatasvir) | genotype 3a hepatitis C | |
| genotype 6 HCV | Drug: Epclusa (sofosbuvir and velpatasvir) | genotype 6 hepatitis C | |
| genotype 3b HCV | Drug: Epclusa (sofosbuvir and velpatasvir) | genotype 3b hepatitis C |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * HCV RNA ≥ 15 IU/Ml at Screening * HCV genotype 3a ,3b and 6 * Hepatitis C without decompensated cirrhosis of the liver Exclusion Criteria: * Patients failed to previous NS5A-containing DAAs therapy * Decompensated cirrhosis * HCC * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
| Facility | City | Country | Status |
|---|---|---|---|
| Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong | China | Recruiting |