Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis

Study of drug resistance virus in oral agents to genotype 1 chronic hepatitis - Study of drug resistance virus to genotype 1 chronic hepatitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019391

Enrollment

200

Registered

2015-10-20

Start date

2015-09-25

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

Genotype 1 chronic hepatitis C

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients were 20 to 85years of chronic HCV genotype 1 infection. Patients received the second generation oral agents(ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir etc.) 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 were excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse were also excluded.

Design outcomes

Primary

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

Secondary

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

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