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Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis

Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis - Efficacy and safety of Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000038587
Enrollment
400
Registered
2019-11-15
Start date
2019-10-25
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

type C decompensated cirrhosis

Interventions

None listed

Sponsors

Nippon Medical School, Division of Gastroenterology and Hepatology, Department of Internal Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Cases of introducing Sofosbuvir / Velpatasvir combination therapy for type C decompensated cirrhosis (2)Age: 18 years old or older (3)Gender: No matter what (4)Hospitalization / outpatient: no question

Exclusion criteria

Exclusion criteria: (1)Patients with a history of hypersensitivity to the ingredients of this drug (2)Patients with severe renal dysfunction (eGFR <30 mL / min / 1.73m2) or renal failure requiring dialysis (3)Patients taking the following drugs Foods containing carbamazepine, phenytoin, phenobarbital, rifampicin, hypericum (St. John's wort) (4)Patient who is pregnant or breastfeeding (5)Patients with hepatocellular carcinoma and other cancers (6)patients who are judged to be inappropriate for participation in the study by the study doctor

Design outcomes

Primary

MeasureTime frame
SVR12 rate (Percent of patients with negative HCV RNA 12 weeks after the end of treatment)

Secondary

MeasureTime frame
(1) Patient background: age, sex, height, weight, complications, medical history (2) Subjective symptoms (3) Presence or absence of liver-related complications: hepatic edema, hepatic encephalopathy, esophageal / gastric varices (4) Clinical laboratory items

Countries

Japan

Contacts

Public ContactHayama Korenobu

Nippon Medical School Division of Gastroenterology and Hepatology, Department of Internal Medicine

leaf0710@nms.ac.jp0338222131

Outcome results

None listed

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