Effect of boceprevir therapy on protective T cell responses : perspectives of novel therapies based on the stimulation of immune responses and of novel monitoring strategies based on the use of immunological parameters
- Conditions
- Chronic active hepatitis C never treated previously with anti-viral terapieMedDRA version: 14.0Level: PTClassification code 10019755Term: Hepatitis chronic activeSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-002911-27-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
· Male or female, aged from 18 to 70 years old, inclusive. · Willing and able to provide written informed consent · Chronic HCV infection for at least 6 month prior to baseline (Day 1) in subjects currently positive for HCV-RNA and anti-HCV antibody documented by: · A positive anti-HCV antibody test, positive HCV-RNA assay, or HCV genotype test at least 6 month prior to baseline (Day 1) or · Subjects must have liver biopsy results (performed no more than two years prior the screening) indicating the absence of cirrhosis · HCV infection limited to genotype 1 · Detectable plasma HCV-RNA at screening · BMI between 18 and 36 Kg/m2 · Eligible subjects must also be HCV treatment-naïve, defined as no prior exposure to PEG-INF and ribavirin, and must be eligible to standard of care therapy with PEG/RBV · Subjects must have the following laboratory parameters at screening: ALT and AST £ 5 x upper limit of normal range (ULN) Hemoglobin (Hb) ³ 12 g/dl WBC ³ 2.500 cells/mL with absolute neutrofil count ³ 1500 cells/mL If a woman of childbearing potential, must have negative serum b-human chorionic gonadotropin (b-HCG) 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 A female subjects of childbearing potential and nonvasectomized male subjects with a female partners of childbearing potential must agree that they and their partner will use effective contraception (two separate forms of contraception simultaneously, one of which must be a male condom with spermicide) from screening throughout the duration of study treatment and for at least 7 months
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
· Pregnant women or women who may wish to become pregnant during the course of the study · Male with a female who is pregnant or is planning to become pregnant within seven month the study of anticipated last dose of ribavirin · Evidence of infection or co-infection with a no-genotype 1 HCV-strain · History of hemoglobinopathy · History of sarcoidosis · History of invasive malignancy diagnosed or treated within 5 years. · Untreated or significant psychiatric illnesses including severe depression, schizophrenia, psychosis, history of a suicide attempt · Co-infection with HBV or HIV · Chronic use of systemic immunosuppressive agents · Presence of autoimmune disorders; subjects with treated hypothyroidism with normal TSH may be enrolled · History of significant cardiac disease · Clinical evidence of chronic pulmonary disease · Known cirrhosis · History of solid organ transplantation · Suspicion of hepatocellular carcinoma · Chronic liver disease of a non-HCV etiology · Ongoin alcohol abuse · History of clinical relevant drug abuse · Positive urine screen for cocaine, opiate etc, or methadone use
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method