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 naïve subjects with chronic genytype 1 hepatitis C infection.

• Conditions: Hepatitis C infection; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2007-001044-44-AT
• Lead Sponsor: Tibotec BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-11
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Male and female subjects 18-65 years of age, inclusive.
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.
Note: To ensure an equal balance between the sub-genotypes 1a and 1b, the number of patients from either sub-genotype will be limited to a maximum of 60% of the total number of patients.
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/mm3
Platelet count: = 100,000/mm3
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 visit to assess the degree of liver fibrosis and the reports from either diagnostic procedure are documented in the subject’s medical chart. 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. Female subjects of childbearing potential must agree to the use of two effective methods of contraception, if heterosexually active, from screening until 4 months after last dose of RBV.
Non-vasectomized male subjects who have a female partner of childbearing potential must agree to the use of two effective methods of contraception, if heterosexually active, from screening until 7 months after last dose of RBV.
Note: Hormonal contraceptives may not be reliable when taking telaprevir.
Therefore, to be eligible for this trial, female subjects should use 2 barrier methods during telaprevir treatment and the subsequent month. Barrier contraceptives include but are not limited to the following methods: male condom, diaphragm with spermicidal jelly, cervical cap, or female condom.
(note that the female condom should not be used simultaneously with a latex male condom because the friction between the two condoms may cause the condoms to break)
As of one month after completion of telaprevir treatment, hormonal contraceptives can be used as one of the 2 required efficient methods of birth control.
Note: The use of birth control methods does not apply if 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.
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

Exclusion Criteria

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 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;
- evidence of autoimmune disease;
- 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 evidence 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 or MRI must be documented within the screening period.
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 breastfeeding, and partners of women who are pregnant or breastfeeding.
9. Hypersensitivity to tartrazine.
10. Subject participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified