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

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 - ESPRiT study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007704

Enrollment

140

Registered

2012-04-09

Start date

2012-02-01

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

(IL28B Major Allele) Telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 12 additional weeks of peginterferon alfa 2b and ribavirin (IL28B Minor Allele) Telaprevir plus peginte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Serogroup 1 and high virus load(>=5 logIU/mL)(regardless of previous IFN treatment) 2) neutorphil : >=1,000/uL Platelet : >=70,000/uL Hemoglobin : >=10g/dL (less than three months before treatment start) 3) Patients with ECOG Performance Status (PS) of 0 or 1 4) IL28B SNP(rs8099917)is known.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Sustend virologic response (SVR)	—

Secondary

Measure	Time frame
(1)End of treatment response (ETR) (2)Virologic response at 12 week after the end of therapy (3)Changes in HCV RNA level (4)Dose of telaprevir (5)Adverse events	—

Countries

Japan

Contacts

Public ContactHiroki Ikeda

St. Mariaana University School of Medicine Gastroenterology and Hepatology

ikedahi@marianna-u.ac.jp044-977-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026