Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy to genotype 2 chronic hepatitis

Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy to genotype 2 chronic hepatitis - Study of drug resistance virus in Sofosbuvir/Ribavirin combination therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000017755

Enrollment

200

Registered

2015-06-10

Start date

2015-06-10

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

Genotype 2 chronic hepatitis C

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients are 20 to 85 years old of genotype 2 chronic hepatitis C patients. Patients are prescribed p.o. sofosbuvir of 400 mg/day combined with ribavirin of 600-1000 mg/day for 12 weeks.

Exclusion criteria

Exclusion criteria: Patients with decompensated liver disease, coinfection with hepatitis B virus or human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease are excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse are also excluded.

Design outcomes

Primary

Measure	Time frame
The dynamic state of drug resistance virus is studied before pre-treatment and viral breakthrough.	—

Secondary

Measure	Time frame
HCV RNA levels are assessed at pre treatment and 2, 4, 8, 12weeks or end of treatment and at 12 and 24 weeks after completion of treatment, and routine biochemical and hematological tests are also assessed.	—

Countries

Japan

Contacts

Public ContactHideki Fujii

Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology

fuhideki@koto.kpu-m.ac.jp075-251-5519

Outcome results