A phase IV Study to Evaluate the Safety and Effectiveness of Sofosbuvir-containing Treatment Regimens in Patients with Chronic Hepatitis C Virus (HCV) Infection in a Chinese Real-World Setting

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023342

Enrollment

Unknown

Registered

2019-05-23

Start date

2019-05-28

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV

Interventions

Case series:Case series

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Chinese patients with chronic hepatitis C infection, who are eligible to initiate sofosbuvircontaining regimens, according to the local prescribing information approved by CNDA. 2. Chinese patients eligible for sofosbuvir-containing regimen in accordance with the approved product information; 3. Patients who provide written and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Participating in clinical trial of HCV treatment in same time (except trials not testing investigational medicinal products); 2. Unable to complete the treatment and unable to follow up for verification of SVR at week 12; 3. Patients being treated with generic SOF regimen.

Design outcomes

Primary

Measure	Time frame
the rates of AEs;	—

Secondary

Measure	Time frame
SVR12 rates;	—

Countries

China

Contacts

Public ContactAlan Liping Zhao

Gilead Sciences Shanghai Parmaceutical Technology Co.,Ltd.

alan.zhao@gilead.com+86 18618178535

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026