The evaluation of liver fibrosis by acoustic radiation force impulse (ARFI) in hemodialysis patients with chronic hepatitis C

Not Applicable

• Conditions: chronic hepatitis C

• Registration Number: JPRN-UMIN000011248
• Lead Sponsor: Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients under 20 years old 2) Patients with co-infection with hepatitis B virus 3) Patients with co-infection with human immunodeficiency virus 4) Patients with alcoholic liver disorder or autoimmune hepatitis 5) Patients with uncompensated cirrhosis or hepatic failure 6) Patients with multiple organ failure or immunological deficiency 7) Patients with severe depression or past history of psychiatric disorder 8) Patients in pregnancy or lactating or patients who expect to become pregnant 9) Patients whose hemoglobin levels are less than 8.5g/dL 10) Patients whose platelet counts are less than 25,000/microL 11) Patients whose neutrophil counts are less than 500 /microL 12) Patients whom investigator disqualified

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- The accuracy of ARFI for evaluation of liver fibrosis in hemodialysis patients with chronic hepatitis C - Comparison of the degree of liver fibrosis between hemodialysis patients with CH-C, non-hemodialysis patients with CH-C and hemodialysis patients without HCV infection - Comparison for progression rate of fibrosis by ARFI between CH-C patients with or without hemodialysis - Comparison for cumulative incidence of HCC by ARFI between CH-C patients with or without hemodialysis - Investigating sustained virological response rate (the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment) of Peg-IFN alpha mono-therapy in CH-C patients with hemodialysis - Comparison of regression rate of liver fibrosis and suppressive effect on HCC incidence of Peg-IFN alpha mono-therapy in CH-C patients with hemodialysis between CH-C patients with or without HD and HD patients without HCV infection