A Study of RO5024048 in Combination With Telaprevir, Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 who were prior null responders to Pegylated Interferon/Ribavirin Treatment

• Conditions: Chronic Hepatitis C (CHC), Genotype 1; MedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002715-28-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

? Male or female aged 18 years and older
? Serologic evidence of CHC infection by an anti-HCV antibody (Ab) test (current or historical)
? Evidence of CHC infection > 6 months duration
? Serum HCV RNA quantifiable at ? 50,000 IU/mL as demonstrated by the Roche COBAS® TaqMan® HCV Test
? Evidence of HCV genotype 1a or 1b infection by molecular assay
? The following information related to the patient?s response to the previous course of PEG-IFN/RBV therapy must be available in the medical records of the patient: (1) approved doses of prior PEG-IFN/RBV treatment and the start/end date of previous treatment with PEG-IFN/RBV, (2) documentation of previous dose modifications or interruptions (or lack thereof) to ensure documentation of previous compliance with therapy, (3) HCV RNA prior to the start of previous treatment and at 12 weeks after the start of treatment (window of Week 11 to Week 16) showing a null response, defined as a < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV, (4) HCV assay used, and (5) limit of detection of the assay used.
? Chronic liver disease consistent with CHC infection as seen via biopsy, using the scoring methods in Appendix B. Patients not yet designated as having cirrhosis or incomplete/transition to cirrhosis must have had a liver biopsy consistent with CHC within 24 calendar months of the first dose. For patients with cirrhosis or incomplete/transition to cirrhosis, there is no time frame for the biopsy.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

? Positive test at screening for anti?hepatitis A virus (HAV) IgM Ab, hepatitis B surface antigen (HBsAg), or anti-HIV Ab
? History of having received RO5024048/telaprevir or any cross-resistant DAA agent at any previous time or use of any other systemic antiviral therapy with established or perceived activity against HCV ? 3 months prior to the first dose of study drug
? History of having received any investigational drug ? 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study.
? History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, Wilson?s disease, alpha-1 antitrypsin deficiency, alcoholic liver disease, and/or toxin exposure)
? Females who are pregnant or breastfeeding
? Males with female partners who are pregnant
? Absolute neutrophil count (ANC) < 1.5 × 103 cells/?L (< 1.5 × 109 cells/L)
? Platelet count < 90 × 103 cells/?L (< 90 × 109 cells/L)
? Hemoglobin concentration < 12 g/dL (120 g/L) in females or < 13 g/dL (130 g/L) in males or a baseline increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or in those for whom anemia would be medically problematic
? 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 6 months
? Any patient with a history of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease who does not agree to have a psychiatric evaluation at screening and who does not agree to have continued monitoring by a mental health specialist at least every 4 weeks during the study
? History of immunologically mediated disease (e.g., vasculitis, cryoglobulinemia, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis requiring more than intermittent non-steroidal anti-inflammatory medications for management).
? History or other evidence of decompensated liver disease. Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
? Serum creatinine > 1.5 times the ULN
? History of pre-existing renal disease. Patients with a history of nephrolithiasis will be allowed.
? Estimated creatinine clearance (CRCL) of ? 70 mL/min (? 1.17 mL/sec), calculated by the Cockcroft-Gault formula (see Appendix C)
? Type 1 or 2 diabetes with glycosylated hemoglobin (HbA1c) of ? 8.5% at the screening visit
? History or other evidence of chronic pulmonary disease associated with functional limitation
? History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina, or other significant cardiovascular disease).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified