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 werenever treated before.

Phase 1

Conditions: Hepatitis C Virus (HCV)
MedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2010-021628-84-BE

Lead Sponsor: Tibotec BVBA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 704

Inclusion Criteria

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 and normal abdominal ultrasound. If AFP > 50 ng/mL or ultrasound abnormal, absence of a mass must be demonstrated by a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. If a subject was screened for hepatocellular carcinoma within 5 months of the screening visit, this screening (ultrasound, CT, 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

Exclusion Criteria

1. Subject is infected or co-infected with HCV of another genotype than genotype 1.
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 (including thalassemia major, sickle-cell disease);
- history or clinical evidence of significant cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia) 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 (e.g., Crohn’s disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, and autoimmune hepatitis).
4. Subject has known allergies, hypersensitivity, or intolerance to telaprevir or its excipients.
5. Subject uses disallowed therapies (see Section 8).
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 (with the exception of treated basal cell carcinoma).
10. Subject has history of seizure disorders (except for childhood seizures that have not persisted).
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 or a similarly qualified healthcare provider (e.g., an optometrist) 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 or similarly qualified healthcare provider should cond

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