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A multicenter, prospective study exploring the management model of ZERO-HD in 14 hemodialysis centers in Sichuan Province

A multicenter, prospective study exploring the management model of ZERO-HD in 14 hemodialysis centers in Sichuan Province

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090386
Enrollment
Unknown
Registered
2024-09-29
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

hepatitis C

Interventions

DAAs treatment group:Sofobuvir/Vipataivir (SOF/VEL) 400mg/100mg once daily for 12 weeks (plus ribavirin for 12 weeks in patients with compensated hepatitis C virus genotype 3 cirrhosis
Patients with decompensated cirrhosis may be given ribavirin for 12 weeks or extended to 24 weeks)

Sponsors

Sichuan Academy of Medical Sciences • Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients aged =18 years and undergoing maintenance hemodialysis in 14 hemodialysis centers in Sichuan Province; (2) Newly treated patients who are anti-HCV and HCV RNA positive and not anti-HCV; (3) Patients who agree to join and sign informed consent; (4) Clinical data, medical history, examination records and other data can be fully traceable; (5) Obtain approval from the Ethics Committee.

Exclusion criteria

Exclusion criteria: (1) Age <18 years old; (2) Pregnant or lactating women; (3) has any serious or active physical or mental illness (such as depression) that, in the investigator's opinion, interferes with the subject's treatment, evaluation, or protocol compliance; (4) Combined with HAV, HDV, HEV, HIV and other infected persons; (5) Patients with alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, genetic metabolic liver disease, etc.; (6) suffering from malignant tumors, including hepatocellular carcinoma; (7) Incomplete clinical data, including baseline data, follow-up data or outcome data, could not meet the data analysis of this study. (8) Patients who explicitly refused to participate in this study.

Design outcomes

Primary

MeasureTime frame
HCV RNA;AFP;eGFR;Scr;

Secondary

MeasureTime frame
PLT;HGB;ALT;AST;ALB;TBIL;End-of -treatment virological response,ETVR);Sustained virological response,SVR);

Countries

China

Contacts

Public ContactXiaoxia Geng

Sichuan Academy of Medical Sciences • Sichuan Provincial People's Hospital

gengxiaoxia@126.com+86 189 8183 8225

Outcome results

None listed

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