Can protective T cell responses be improved by telaprevir therapy in patients with chronic hepatitis C who have deeply inhibited HCV-specific T cells?

• Conditions: Chronic active hepatitis C never treated previously with anti-HCV therapies; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004138-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-22
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Be a man or woman between 18 and 70 years of age • Sign the informed consent document indicating that they understand the purpose of and procedures required for the immunological study • Have evidence of HCV infection with genotype 1 (molecular assay) diagnosed at least 6 months before the baseline • Have documented mild or moderate liver fibrosis (Metavir F0-F2 or Ishak 0-2) assessed by liver biopsy in the past 12 months • Have a favorable IL28B genotype (CC) • BMI < 30 • Absence of contraindications to pegInterferon and ribavirine • If a women of childbearing potential, must have a negative serum ? human chorionic gonadotropin (? hCG) or urine pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment. • If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 4 months (female subject) or 7 months (male subject) after RBV therapy has ended.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Pregnant woman or woman who wants to become pregnant during the course of the study • Infected or coinfected with HCV of a genotype other than genotype 1 • CT or TT genotype of IL28, presence of severe fibrosis at the liver biopsy (Metavir > 2 o Ishak > 2) • History of hemoglobinopathy, sarcoidosis, invasive neoplasia diagnosed or treated in the previous 5 years • History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease • Co-infection with HBV or HIV • Chronic use of systemic immunepressive agents • Presence of autoimmune disorders; patients with hypothyroidism and normal TSH can be enrolled • History of severe heart or chronic pulmonary diseases • History of solid organ transplantation • Suspected hepatocellular carcinoma • Alcohol or drug abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified