A study to find out the how your body reacts, absorbs, metabolizes and eliminates a combination of drugs and their ability to reduce the activity of a virus that causes permanent inflammation of the liver (Hepatitis C virus).

• Conditions: Chronic Hepatitis C; 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: EUCTR2011-004129-28-SK
• Lead Sponsor: F. Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-06
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Gender : Male and Female
• History of CHC GT 1 or GT 4, documented with HCV genotype and serum HCV RNA of > 1 x 105 IU/mL at Screening.
• HCV-treatment-naive Cohort 1 (ie, have never received treatment for their condition including but not limited to IFN-based therapy, RBV, or other anti-viral agents with established or perceived activity against HCV).
• HCV prior P/R null responders for Cohort 2. Documentation of previous treatment failure after starting treatment with approved doses of PEG-IFN plus RBV. Patients must have been adherent to previous therapy and have taken a minimum of approximately 80% of the previous course of therapy for a least the first 12 weeks as estimated by the investigator in consultation with the patients and must have failed treatment as a consequence of null virologic response (<2 log 10 reduction in HCV RNA at week 12).
• Liver biopsy confirming cirrhosis: Knodell score = 4, Metavir score = 4, Batts & Ludwig score = 4, or Ishak modified HAI score = 5
• Compensated cirrhosis (Child-Pugh A)
• Patients must have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 6 months prior to Screening), and a serum alfa-fetoprotein (AFP) <100ng/mL (< 100 µg/L at Screening).

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices).
• For Cohort 2: Patients who discontinued previous P/R therapy due to reasons other than null response (eg, intolerability, lost to follow up, noncompliance).
• Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, alfa-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson’s disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy.
• Positive Hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV) antibody at Screening.
• Use of blood transfusion growth factors (including, but not limited to, granulocyte colony stimulating factor or erythropoietin) or any other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within 3 months before Screening
• History of severe psychiatric disease
• Laboratory parameters: ALT > 10x ULN; Bi =1.5x ULN; serum amylase or lipase > 1.5 x ULN; Hgb < 12- g/L (males), < 120 g/L (females): HA1c =8.5;CrCl < 70 mL/min, microproteinuria and Uprotein/Cr ratio = 0.3 (33.89 mg/mmoL; ANC = 1500 /µL; platelets = 90,000/µL

Study & Design

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