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Efficacy and safety of Sofosbuvir and Velpatasvir for Japanese patients with HCV related hepatitis in real-world setting

sofosbuvir/velpatasvir for Japanease patients with hepatitis C - SOF/VEL for hepatitis C in Japan

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050842
Enrollment
60
Registered
2023-04-14
Start date
2023-04-14
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

chronic hepatitis C patients with or without compensated cirrhosis

Interventions

None listed

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects Subjects will be chronic hepatitis C patients with or without compensated cirrhosis who visit or are admitted to the study sites participating in this study between the day of permission to conduct the study and June 2025. Inclusion Criteria 1. The subject is aged 20 years or older at the time of informed consent. 2. Patients with chronic hepatitis C with or without compensated cirrhosis treated with the combination of sofosbuvir and velpatasivir for 12 weeks in routine clinical practice 3. A person who has received sufficient explanation before participation in this research and obtained voluntary consent of the subject himself/herself with sufficient understanding

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1.Patients who are judged by the research lead to be inappropriate for participation in this review 2.Other persons who are judged by the principal investigator to be inappropriate as research subjects *Patients who discontinue treatment due to adverse drug reactions, etc. will not be excluded from the study.

Design outcomes

Primary

MeasureTime frame
HCV-RNA conversion rate at 12 weeks after the end of treatment, occurrence of adverse reactions

Secondary

MeasureTime frame
1) Assessment of the number of visits during treatment, therapeutic effects, and safety 2) Emergence of drug resistance mutations in non-responders 3) Improvement in liver fibrosis and Child-pugh score 4) AFP improvement effect 5) Glucose-Lipid-Related Factors and Therapeutic Effects 6) Effect of virus elimination on renal disorder Adverse events

Countries

Japan

Contacts

Public ContactGOKI suda

Hokkaido University Hospital Department of Gastroenterology and Hepatology

gsudgast@pop.med.hokudai.ac.jp+819012640151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026