A study to compare two dosing schedules (every 8 hours versus twice daily) for telaprevir when combined with pegylated interferon alfa-2a, ribavirin and hepatitis C virus genotype 1 in patients with HCV-1 who were never treated before.
- Conditions
- Hepatitis C Virus (HCV)MedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-021628-84-GB
- Lead Sponsor
- Janssen Infectious Diseases BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 704
1. Subject is a man or a woman between 18 and 70 years of age, inclusive.
2. Subject has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL.
Genotype must be confirmed during screening. Chronic infection status must be
confirmed by detectable HCV RNA more than 6 months before the screening visit or by histological diagnosis of chronic hepatitis based on the liver biopsy.
3. Subjects should not have had any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C.
4. Subject is judged to be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
5. Subject must have documentation of a liver biopsy within 2 years before the screening visit or the subject must agree to have a biopsy performed within the screening period. If a biopsy more than 2 years prior to screening has already demonstrated histological cirrhosis, the biopsy does not need to be repeated if the biopsy report can be provided.
6. Subjects with cirrhosis should have serum alpha-fetoprotein (AFP) = 50 ng/mL. If AFP> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period. In case the ultrasound results are ambiguous, a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan should be performed. If a subject was screened for hepatocellular carcinoma within 5 months of the screening visit, this screening (ultrasound, CT, or MRI) can be used to fulfill the inclusion criterion.
7. If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV.
Note: Hormonal contraceptives may not be reliable when taking telaprevir. Therefore, to be eligible for this study, subjects should use 2 other effective birth control methods during telaprevir treatment and for 2 months after the last intake of telaprevir
8. Subject or female partner is not pregnant, planning to become pregnant, or breastfeeding.
All female subjects must have a negative serum ß-human chorionic gonadotropin
(ß-hCG) pregnancy test at screening.
9. Subject is willing/able to adhere to the prohibitions and restrictions specified in this protocol.
10. Subject must have signed an Informed Consent Form (ICF) including consent to IL28B testing, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
11. Subjects should agree not to participate in other clinical studies for the duration of their participation in this study, except for noninterventional or observational studies and only after prior approval of the sponsor.
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 688
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
1. Subject is infected or co-infected with HCV of another genotype than genotype 1.
2. Subject is infected with HCV genotype 1 exhibiting more than one subtype.
3. Subject presents a contraindication to the administration of Peg-IFN-alfa-2a or RBV, including but not limited to any of the following:
- hypersensitivity to Peg-IFN-alfa-2a, RBV, or any of their components;
- hemoglobinopathies;
- history or clinical evidence of significant cardiac disease and/or clinically significant ECG abnormalities;
- abnormal thyroid function that is not adequately controlled;
- poorly controlled diabetes mellitus as evidenced by hemoglobin A1c (HbA1c) = 8.5% at screening;
- creatinine clearance = 50 mL/min at screening;
- antinuclear antibody (ANA) titer = 1:640 at screening or other evidence of autoimmune-mediated disease.
4. Subject has known allergies, hypersensitivity, or intolerance to telaprevir or its excipients
5. Subject uses disallowed therapies.
6. Subject has a pre-existing psychiatric condition, including but not limited to:
- severe depression or hospitalization for depression;
- schizophrenia, bipolar illness, severe anxiety, or personality disorder;
- a period of disability or impairment due to a psychiatric disease within the past 5 years.
7. Subject has history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
- International Normalized Ratio (INR) of = 1.5;
- Serum albumin < 3.3 g/dL;
- Serum total bilirubin > 1.8 times upper limit of laboratory normal range (ULN), unless isolated or in subjects with Gilbert’s Syndrome.
8. Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, Nonalcoholic Steatohepatitis (NASH), or primary biliary cirrhosis.
9. Subject has active malignant disease or history of malignant disease within the past 5 years.
10. Subject has history of seizure disorders.
11. Subject has congenital or acquired prolonged QT interval, a history of nonsustained or sustained ventricular tachycardia, or a history of drug-induced QT prolongation and/or Torsade de Pointes.
12. Subject has history of organ transplant that requires chronic immunosuppression. Note: corneal, skin, and hair grafts are allowed.
13. Subject has a medical condition that requires chronic or intermittent use of systemic corticosteroids.
14. Subject has history or other evidence of clinically significant retinopathy or ophthalmological disorder, including but not limited to disorders due to diabetes mellitus or hypertension. Clearance by an ophthalmologist is required within 3 months prior to screening or within the screening period for all subjects with diabetes mellitus, hypertension, or known retinal disorders. The ophthalmologist should conduct a fundoscopic exam, which should be documented in the subjects’ records. The findings of the exam must also be recorded on the electronic Case Report Form (eCRF).
15. Subject has clinical evidence of chronic pulmonary disease associated with functional impairment.
16. Subject has evidence of hemophilia or other bleeding disorder.
17. Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis.
18. Subject has human immunodeficiency virus (HIV) or hepatitis B virus (H
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method