Effectiveness and safety of simeprevir-basd triple therapy for chronic hepatitis C in multicenter study

Effectiveness and safety of simeprevir-basd triple therapy for chronic hepatitis C in multicenter study - Effectiveness and safety of simeprevir-basd triple therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014568

Enrollment

400

Registered

2014-07-16

Start date

2013-12-01

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients infected with chronic hepatitis C virus genotype 1

Exclusion criteria

Exclusion criteria: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen (2) clinical or biochemical evidence of hepatic decompensation (Child-Pugh B or C, ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (hemochromatosis, autoimmune hepatitis, or primary biliary cirrhosis) (4) excessive active alcohol consumption (a daily intake of more than 40g of ethanol), drug abuse or severe mental disorder (5) the presence of active cancer at entry (6) experienced treatment with telaprevir

Design outcomes

Primary

Measure	Time frame
Sustained viral response (SVR)	—

Secondary

Measure	Time frame
Factors associated with SVR Adverse effects (anemia) Efficacy and safety for older patients	—

Countries

Japan

Contacts

Public ContactEiichi Ogawa

Kyushu University Hospital Department of General Internal Medicine

eogawa@gim.med.kyushu-u.ac.jp092-642-5909

Outcome results