Effectiveness of simeprevir-based triple therapy for patients with telaprevir failure

Effectiveness of simeprevir-based triple therapy for patients with telaprevir failure - Effectiveness of simeprevir for patients with telaprevir failure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016205

Enrollment

Registered

2015-01-13

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: 1. Patients infected with chronic hepatitis C virus genotype 1 2. Telaprevir-experienced patients

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

Design outcomes

Primary

Measure	Time frame
Sustained virological response (SVR)	—

Secondary

Measure	Time frame
1. Predictors associated with SVR 2. Safety of simeprevir-based triple therapy 3. Association between HCV variants and efficacy	—

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