Status:
COMPLETED
Effect of Boceprevir on HCV-specific T Cell Responses
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Brief 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
Detailed Description
Reconstitution of the antiviral T cell function may represent a component of the anti-viral effect of protease inhibitors. If T cell responsiveness is restored under therapy, potentiation of anti-vira...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01403181
Start Date
April 1 2012
Last Update
November 6 2013
Active Locations (1)
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1
Unit of Infectious Diseases and Hepatology
Parma, Italy, Italy, 43126