Chronic Hepatitis C Genotype 1 Virus Infection (Treatment-Naive Patients) MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Product Name: HCV-Protease
Product Code: RO5190591/F02 (ITMN-191)
Pharmaceutical Form: Capsule, soft
Current Sponsor code: RO519-0591/F02 (ITMN-191)
Concentration unit: mg milligram(s)
Concentration t
Sponsors
F.Hoffmann-La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years and older 2. Serologic evidence of CHC infection by an anti-HCV antibody test (current or historical) 3. Evidence of chronic hepatitis C infection > 6 months duration 4. Evidence of hepatitis C genotype 1 infection by molecular assay 5. Serum HCV RNA quantifiable at = 50,000 IU/mL as demonstrated by the Roche COBAS TaqMan HCV Test 6. HCV treatment-naïve (i.e. have never received treatment for CHC, including but not limited to IFN-based therapy, ribavirin, or other anti-viral agents with established or perceived activity against the HCV virus) 7. Liver biopsy within the past 24 months showing clear absence of advanced fibrosis or cirrhosis (as indicated in Appendix 1). Liver biopsy should be scored using one of the scoring methods in Appendix 1. 8. Normal cardiac troponin I (cTnI) value at the screening visit (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Infection with any HCV genotype other than genotype 1 or an indeterminate or mixed genotype. Genotype 1 pts w indeterminate or mixed subtypes will be allowed 2. History of having received any IMP = 3m prior to the 1st dose of study drug or the expectation that such drugs will be used during the study. Pts enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes Pts who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excl 4. + test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab 5. History or other evidence of a medical condition associated with chronic liver disease other than HCV 6. Females who are pregnant or breast feeding 7. Male partners of females who are pregnant 8. BMI 1.5* the upper limit of normal at screening 13. The use of colony stimulating factors such as granulocyte colony stimulating factor (G-CSF), erythropoietin, blood transfusion or other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within the last 6m 14. Hist of severe psychiatric disease, incl psychosis and/or severe depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease. In add, pts w a concurrent psychiatric condition or history of a psychiatric condition that, in the opinion of the Inv and/or Psychiatrist, would compromise participation in this study 15. Hist of immunologically mediated disease 17. Poorly controlled hypertension, with a hist of poor adherence to antihypertensive therapy or screening or baseline blood pressure of systolic = 160 mmHg and/or diastolic =100 mmHg 18. Type I or II diabetes with HbA1C > 8.5% at the Screening Visit 19. Hist or other evidence of chronic pulmonary disease associated with functional limitation 20. Hist of severe cardiac disease. In add, pts w doc or presumed coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease should not be enrolled 21. Pts w higher potential for QTC prolongation; defined by QTC = 450 ms, or notable resting bradycardia 100 beats/min or personal or family history of congenital long QT syndrome or sudden death 22. Hist of uncontrolled severe seizure disorder 23. Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2y. 24. Hist of any systemic anti-neoplastic or immunomodulatory treatment (incl supraphysiologic doses of steroids and radiation) = 6m prior to the 1st dose of study drug or the expectation that such treatment will be needed at any time during the study 25. Poorly controlled thyroid dysfunction 26. Hist or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history /other evidence of severe retinopathy 27. Hist of major organ transplantation with an existing functional graft 28. Hist or other evidence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability, and effect on virologicalresponse of a 12 weeks duration of RO5190591 incombination with Pegasys and Copegus compared to thecombination of Pegasys and Copegus alone in treatment-naïvepatients with chronic hepatitis C genotype 1 virus infection;Secondary Objective: To evaluate the pharmacokinetics of RO5190591 in combination with Pegasys and Copegus To evaluate the viral resistance profile of RO5190591 in combination with Pegasys and Copegus;Primary end point(s): The primary measure of efficacy is SVR defined as the percentage of patients with undetectable HCV RNA as measured by the Roche COBAS TaqMan HCV Test (detection limit = 15 IU/mL) 24 weeks after end of treatment (SVR-24; a single last HCV RNA undetectable = 20 weeks after last dose). Patients without HCV RNA measurements at the end of the 24-week treatment-free follow-up period will be considered non-responders. This definition of SVR will be “SVR according to actual treatment period”. | — |
Countries
Austria, France, Germany, Italy
Outcome results
None listed