A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naive subjects with chronic genotype 1 hepatitis C infection.

Phase 2

Completed

Conditions: Hepatitis C infection
10019654
10047438

Registration Number: NL-OMON30970

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

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.