Effect of Boceprevir on HCV-specific T Cell Responses

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Analysis of HCV-specific T cell responses in patients treated with boceprevir to assess whether therapy can induce restoration of the T cell function and to what extent this recovery can be achieved

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma
• Treatments: Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

• 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

• A liver biopsy performed prior to baseline (Day 1) with evidence of chronic HCV infection

• 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) ≥ 12 g/dl WBC ≥ 2.500 cells/μL with absolute neutrophil count ≥ 1500 cells/μL If a woman of childbearing potential, must have negative serum β-human chorionic gonadotropin (β-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

Exclusion Criteria:

• 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

• Ongoing alcohol abuse

• History of clinical relevant drug abuse

• Positive urine screen for cocaine, opiate etc, or methadone use