Hepatitis C infection
Conditions
Interventions
Telaprevir: white to off-white oval tablets containing 375 mg of telaprevir for
oral administration (Phase III formulation).
Peg-IFN alfa2a (Pegasys®): a solution for subcutaneous injection in a
pre
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18-65 years of age. 2. Chronic genotype 1 hepatitis C infection. Chronic disease status must be confirmed by at least 1 of the following standard criteria: - history of a remote risk factor (e.g., intravenous drug abuse or blood transfusion), or - abnormal alanine aminotransferase (ALT) levels for > 6 months prior to screening (note: elevated ALT is not an inclusion criterion if one of the other criteria for chronic hepatitis C is met), or - diagnosis of hepatitis C > 6 months before the screening period. 3. Naïve of therapy for HCV (including investigational products). 4. Screening laboratory values of the following variables must meet the acceptable values defined below: Laboratory variable Acceptable values Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Bilirubin Within normal range (except for subjects with Gilbert*s Syndrome) Hemoglobin Within normal range All other hematology and clinical chemistry must show no clinically significant abnormalities, as judged by the investigator. 5. Detectable plasma HCV RNA > 10,000 IU/mL at entry. 6. Liver biopsy (preferred) or Fibroscan (alternative) within three years of the screening to assess the degree of liver fibrosis. If no biopsy or Fibroscan results are available at screening, such procedure should be performed as part of the screening procedures. 7. Judged to be in otherwise good health, in the opinion of the investigator. 8. Agree to the use of two effective methods of contraception (as outlined in section 5.2.4 of the protocol) if heterosexually active, unless the male partner has undergone a vasectomy or if the female sexual partner has had a bilateral oophorectomy, or a total hysterectomy, or if she is post-menopausal for at least two years. 9. Willing to refrain from the concomitant use of any medications, substances or foods prohibited in this trial. 10. Informed Consent Form (ICF) signed voluntarily before first trial-related activity. 11. Agree not to participate in other clinical studies (with the exception of observational studies) for the duration of his/her participation in this trial.
Exclusion criteria
Exclusion criteria: 1. Presence of a concomitant medical condition that in the opinion of the investigator could influence the results of the trial or that could represent an additional risk for the administration of the study medication to the subject. 2. Any medical contraindications to Peg-IFN alfa2a, Peg-IFN alfa2b, or RBV therapy including but not limited to the following: - abnormal thyroid stimulating hormone (TSH) levels (except if well-controlled on medication) or poorly controlled thyroid function; - evidence of clinically significant cardiac dysfunction; - history of psychiatric disorders determined by the investigator to contra-indicate the use of IFN-based therapy; - antinuclear antibody (ANA) titer >= 1:320; - history of hemoglobinopathies. 3. History or evidence of cirrhosis or decompensated liver disease defined as a prior or current history of ascites, hepatic encephalopathy, bleeding esophageal or gastric varices. 4. Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson*s disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. 5. Diagnosed or suspected hepatocellular carcinoma. Alfa-fetoprotein at screening must be less than 50 ng/mL, or if higher, absence of a mass on an ultrasound must have been documented. 6. History or suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator*s opinion would compromise the subject*s safety and/or compliance with trial procedures. 7. Human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection. 8. Women who are pregnant, planning on becoming pregnant, or breast feeding, and partners of women who are pregnant or breast feeding. 9. Hypersensitivity to tartrazine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following efficacy parameters will be explored: - The proportion of subjects with undetectable HCV RNA at all assessment time points and after the completion of all anti-HCV therapy (EOT); - Time to first undetectable HCV RNA level; - The proportion of subjects with viral breakthrough (defined as an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA had previously become undetectable at all assessment time points; - The proportion of subjects with partial response (at least 2 log drop from baseline, but not undetectable) at all assessment time points; - HCV RNA values and changes from baseline over time; - Early viral kinetics (antiviral effectiveness - epsilon) and changes in HCV RNA from baseline over time during the first week of treatment and thereafter until EOT; - The proportion of subjects in each treatment arm with sustained viral response 24 weeks after the end of treatment (SVR24). Pharmacokinetics and Pharmacodynamics; the following will be explored: the pharmacokinetics of telaprevir and VRT-127394, Peg-IFNs, and RBV; the possible drug-drug interaction of RBV, telaprevir, and each type of Peg-IFN. | — |
Secondary
| Measure | Time frame |
|---|---|
| NAP | — |
Countries
Netherlands
Outcome results
None listed