Efficacy and Safety of Extended Triple Therapy, Peginterferon, Ribavirin and Telaprevir (Telavic) for Genotype1 and High Viral Load Chronic Hepatitis C Patients with IL28B Minor Allele
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000007704
- Lead Sponsor
- St. Mariaana University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
Not provided
1) Patients with HBs antigen positive 2) Pregnant or lactating women, or women who may become pregnant 3) Patients with allergy to telaprevir 4) Patients with severe skin reactions when telaprevir administered 5) Patients with allergy to ribavirin and/or other nucleoside analogs 6) Patients with allergy to IFN 7) Patients with severe heart disease 8) Patients with hemoglobinopathy 9) Patients with contraindicated drugs as below (a)Antiarrhythmics Quinidine Sulfate Bepridil Hydrochloride Hydrate Flecainide Acetate Propafenone Hydrochloride Amiodarone Hydrochloride (b)Ergot derivatives Ergotamine tartrate Dihydroergotamine mesilate Ergometrine maleate Methylergometrine maleate (c)HMG-CoA reductase inhibitors Lovastatin Simbastatin Atorvastatin calcium hydrate (d)PDE5 inhibitors Vardenafil Hydrochloride Hydrate Sildenafil Citrate (for treatment of pulmonary arterial hypertension) Tadalafil (for treatment of pulmonary arterial hypertension) (e)Others Pimozide Triazolam Alfuzosin Blonanserin Colchicine (to patients with liver disorder and/or renal disorder) Rifampicin 10) Patients with renal failure and/or renal dysfunction (=>50mL/min.) 11) Patients with severe psychosis such as severe depression, suicidal ideation or attempt or with history of severe psychosis 12) Patients with autoimmune hepatitis 13) Patients receiving shosaiko-to 14) Patients with history of hypersensitivity to biological products 15) Patients taking other test drugs less than three months before treatment start 16) Patients who were not suitable for this trial judged by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method