Chronic hepatitis C
Conditions
Interventions
None listed
Sponsors
Chugai pharmaceutical CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who received treatment with IFN (including PEG IFN) plus RBV and did not reach sustained virological response (SVR).
Exclusion criteria
Exclusion criteria: 1. Despite of administering adequate doses of PEG IFN plus RBV for 48weeks, HCV RNA did not become negative by 36weeks 2. Patients who have had treatment of PEG IFN plus RBV for 72weeks 3. Coadministration of Shosaikoto 4. History of interstitial pneumonia 5. Autoimmune hepatitis 6. Hypersensitivity to PEG IFN or RBV or to any of the excipients or biological products or nucleotide analogs 7. Low birth weight baby, neonate, infant or children under age 3 8. Pregnancy, uncertainty pregnancy or brest feeding women 9. Uncontrolled cardiac disease 10. Hemoblobinopathies (e.g. thalassemia, sickle cell anemia) 11. Chronic renal failure or CCl<50mL/min of renal dysfunction 12. Histry or presence of severe depression, severe neuropsychiatric disorder with suicidal ideation or suicide attempt 13.Severe hepatic dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response (SVR) rate and confirmation of the safety profile including greater than 48wks treatment period | — |
Countries
Japan
Contacts
Public ContactAyaka Shimizu
Chugai pharmaceutical CO. LTD Real World Data Science Dept.
Outcome results
None listed