Hepatitis C Virus Infection MedDRA version: 9.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV)
Conditions
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. May not have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C 2. Male and female subjects, 18 to 70 years of age, inclusive 3. Genotype 1, chronic hepatitis C with detectable HCV RNA. Genotype must be confirmed during screening. Confirmation that the disease is chronic (as opposed to acute disease of less than 6 months duration) must be by at least 1 of the following criteria: • Diagnosis of HCV >6 months before the screening visit • Abnormal alanine aminotransferase (ALT) levels for >6 months before the screening period (Note: ALT does not have to be elevated to be eligible for the study, but history of elevated ALT can indicate duration of the infection). 4. Screening laboratory values within acceptable ranges 5. Subject must have documentation of a liver biopsy within 1 year before the screening visit, or the subject must agree to have a biopsy performed within the screening period. Liver biopsy must show evidence of hepatitis (demonstrated by inflammation and/or fibrosis). If a biopsy more than 1 year prior to screening has already demonstrated histological cirrhosis, the biopsy does not need to be repeated if this biopsy report can be provided. 6. Subjects (or their female partners) must not be pregnant, or planning to become pregnant throughout the study dosing period and through 6 months post-dosing for female study subjects, 7 months post-dosing for female partners of male study subjects; or they must be permanently sterile or otherwise of non childbearing potential. They must also not be breastfeeding. If of child-bearing potential, female subjects must agree to use 2 effective methods of contraception from screening through 6 months after the last dose of RBV. Male subjects who have a female partner of childbearing potential must agree to use 2 effective methods of contraception from Screening through 7 months after the last dose of RBV unless vasectomized. 7. Willing and able to refrain from the concomitant use of any medications, substances, or foods noted in protocol Section 10.12, from 14 days prior to the first day of dosing through the end of treatment. 8. Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has any contraindications to Peg IFN alfa 2a or RBV therapy, including but not limited to any of the following: • Hypersensitivity to any component of Peg-IFN –alfa-2a or RBV • Hemoglobinopathies (including thalassemia major, sickle-cell disease) • History or other clinical evidence of significant or unstable cardiac disease (e.g. angina, congestive heart failure, recent myocardial infarction, significant arrhythmia) and/or clinically significant ECG abnormalities • Abnormal thyroid function that cannot be controlled effectively by medication • Poorly controlled diabetes mellitus as evidenced by HbA1C = 8.5% at screening • Creatinine clearance = 50mL/min at screening • Antinuclear antibody (ANA) titer ?1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy 2. Evidence of hepatic decompensation in cirrhotic subjects: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or screening laboratory results of any of the following: • International Normalized Ratio (INR) of ?1.5 • Serum albumin 1.8 times the upper limit of normal (ULN), unless history of Gilbert’s disease 3. Any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis 4. Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alfa fetoprotein (AFP) of = 50 ng/mL. If AFP is = 50 ng/mL, absence of a mass must be demonstrated by ultrasound within two months prior to the screening period 5. Active malignant disease or history of malignant disease within 5 previous years (with the exception of treated basal cell carcinoma) 6. Pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study, 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. History of significant craniocerebral trauma or active seizure disorders requiring medication 8. History of organ transplant, with the exception of corneal transplants and skin grafts 9. Medical condition that requires frequent or prolonged use of systemic corticosteroids (e.g., severe asthma, severe arthritis or autoimmune conditions, organ transplantation, adrenal insufficiency, etc.) 10. Autoimmune-mediated disease (e.g., Crohn’s disease, ulcerative colitis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis) 11. History of acute pancreatitis within 5 years prior to the screening visit 12. History or other evidence of severe retinopathy or clinically significant ophthalmological disorder due to diabetes mellitus or hypertension. For subjects with a history of hypertension or diabetes, written clearance from an ophthalmologist has to be obtained before the start of treatment 13. History or other clinical evidence of chronic pulmonary disease associated with functional impairment 14. History of hemophilia 15. Evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis 16. Currently abusing illicit drugs (n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rates of SVR among treatment-naïve HCV genotype 1 subjects treated with telaprevir in combination with peginterferon alfa 2a (Peg IFN alfa-2a) and ribavirin (RBV) who achieve eRVR (defined as undetectable hepatitis C virus [HCV] RNA at Week 4 and at Week 12), and either stop treatment at 24 weeks or continue treatment to 48 weeks.;Secondary Objective: To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with genotype 1 chronic hepatitis C.;Primary end point(s): Proportion of randomized subjects achieving sustained viral response (SVR), demonstrated by achieving undetectable HCV RNA 24 weeks after last dose of study treatment | — |
Countries
Belgium, Netherlands
Outcome results
None listed