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 of naïve subjects with chronic genotype 1 hepatitis C infection - ND
- Conditions
- CHRONIC GENOTYPE 1 HEPATITIS CMedDRA version: 6.1Level: PTClassification code 10019744
- Registration Number
- EUCTR2007-001044-44-IT
- Lead Sponsor
- TIBOTEC BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Subjects who meet all of the following criteria are eligible for this trial. 1. Male and female subjects 18-65 years of age. 2. Chronic genotype 1 hepatitis C infection. Chronic (non-acute) 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 - 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 in protocol Pag 17.4. 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 non invasive method to assess degree of liver fibrosis within three years of the screening visit. 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 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 noted in Section 5.3.10.1. of protocol 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects meeting one or more of the following criteria cannot be selected. 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 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 >or=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. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective is to explore the efficacy, safety, tolerability, pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg-IFN alfa2a (Pegasys) and RBV (Copegus) or Peg-IFN alfa2b (PegIntron) and RBV (Rebetol);Secondary Objective: na;Primary end point(s):
- Secondary Outcome Measures
Name Time Method