Hepatitis C virus (HCV) MedDRA version: 9.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus
Conditions
Sponsors
Tibotec Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this trial: 1. Male and female subjects aged between 18 and 70 years, extremes included. 2. Subjects with documented chronic (diagnosis of hepatitis C > 6 months before the screening period) genotype 2, 3, 4, 5 or 6 HCV infection (confirmed at screening) Note: HCV-infected subjects with hemophilia may be enrolled. 3. HCV treatment-naïve subjects (not receiving or having received any treatment including investigational treatment for HCV with the exception of non-hepatoxic herbal remedies) 4. Patients with either no cirrhosis or up to Child Pugh A (compensated cirrhosis) liver disease. 5. HCV plasma viral load of = 100,000 IU/mL at screening (as assessed by the Taqman assay). 6. Informed Consent Form (ICF) signed voluntarily before the first trial related activity. 7. Able to comply with the protocol requirements and having good accessible veins. 8. Normal weight as defined by a Body Mass Index (BMI: weight in kg divided by the square of height in meters) of 18 to 32 kg/m2, extremes included. 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. Evidence of Child Pugh B or C liver disease at screening; evidence of decompensated liver disease defined as prior or current history of ascites, hepatic encephalopathy, esophageal or gastric varices. 2. 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, non-alcoholic steatohepatitis, or primary biliary cirrhosis. 3. Subjects with diagnosed or suspected hepatocellular carcinoma. 4. Subjects (male or women of childbearing potential) not agreeing to use highly effective birth control methods i.e. two separate forms of contraception, from screening through 90 days after the last dose of TMC435 and to continue if applicable (i.e. when continuing on SoC treatment) as dictated by the approved product information of the medication administered. For details see paragraph 5.2.4. 5. Use of herbal medications, dietary supplements and products containing Hypericum perforatum (e.g. St. John’s wort) in a period of 14 days before the first trial medication intake until end of pharmacokinetic assessments (96 h post last dose of study medication). 6. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the Investigator’s opinion would compromise the subject’s safety and/or compliance with the trial procedures (period of non-drug/alcoholic misuse must at least be 1 month before the first administration of trial medication). 7. A positive urine drug test at screening. Urine will be tested to check the current use of amphetamines, cocaine, and opioids (with the exclusion of methadone or equivalents). 8. Subjects with at least one of the following laboratory abnormalities as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (see Section 7.2, Addendum 2) at screening: - Bilirubin > 1.25x upper limit of laboratory normal range (ULN) (when accompanied by any increase in other liver function test) or > 1.5 x ULN (when other liver functions are in the normal range) - Platelet count < 90,000/mm3; - White blood cell (WBC) count < 2,000 cells/mm3; - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 4; - Any other lab toxicity found to be clinically significant by the Investigator. Note: Retesting of abnormal screening values that lead to exclusion will be allowed once using an unscheduled visit during the screening period. 9. Subjects coinfected with human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2), or hepatitis A or B virus infection (confirmed by hepatitis A antibody immunoglobulin [IgM], or hepatitis B surface antigen [HBsAg]) or active tuberculosis at screening. 10. Subjects with any active clinically significant disease (e.g., cardiac dysfunction, cardio(myo)pathy, cardiac insufficiency, pancreatitis, renal insuffiency), or medical history or physical examination or electrocardiogram (ECG) findings during screening that, in the Investigator’s opinion, would compromise the outcome of the trial. 11. Subjects having uncontrolled/unstable diabetes, active epilepsy or history of epilepsy, history of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt. 12. Subjects enrolled in another clinical trial within 90 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to determine the antiviral activity of TMC435 during 7 days q.d. dosing at 200 mg as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected subjects.;Secondary Objective: The secondary objective of this trial is to determine the safety, tolerability and pharmacokinetic profile of TMC435 during 7 days q.d. dosing at 200 mg as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected subjects.;Primary end point(s): Determine the antiviral activity of TMC435 | — |
Countries
Belgium, Germany
Outcome results
None listed