A Randomized, Open-Label, Multicenter Study Examining the Effects of 24 Versus 48 Weeks of Combination Therapy with PEGASYS® (Peginterferon alfa-2a 40KD) plus COPEGUS® (Ribavirin) on Sustained Virological Response in Patients with Chronic Hepatitis C, Genotype 2 or 3 who do not Achieve a Rapid Viral Response - NCORE 2/3
- Conditions
- Chronic hepatitis CMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2007-004993-15-BE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Male and female patients greater than or equal to 18 years of age at treatment initiation
Serologic evidence of chronic hepatitis C (CHC) infection by an anti-HCV antibody test prior to therapy
Patients with CHC genotype 2 or 3
Patients in whom therapy with PEGASYS® plus COPEGUS® was initiated at the discretion of the investigator according to local standard of care with PEGASYS® 180µg/week plus COPEGUS® 800 mg/d or 1000/1200 mg/d adhering to the sections: Contraindications” and Special Warnings and Precautions” of the current summaries of product characteristics (SPCs) / US Product Information (USPI) / local labeling (Please refer to the Investigator’s Folder for local labeling).
Quantifiable Serum HCV RNA >43 IU/mL by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test within 3 months prior to treatment initiation with PEGASYS® plus COPEGUS®
Detectable Serum HCV RNA by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after 4 weeks of treatment with PEGASYS® plus COPEGUS® (i.e. 21 to 35 days after start of treatment)
Information on PEGASYS® and COPEGUS® compliance including dose modifications and treatment interruptions during the first 6-8 weeks of treatment have to be available and are documented in the patient chart
Patient must be able to comply with the adherence assessments during the study
Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score less than or equal to 6)
Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug (i.e. treatment week 6-8)
All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion
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 at Study Entry (treatment week 6-8)
• Women with ongoing pregnancy or breast feeding
• Male partners of women who are pregnant
• Patients with CHC genotype 1
• Pegylated interferon, standard interferon or ribavirin therapy at any time prior to
initiation of the current therapy with PEGASYS® plus COPEGUS®
• Any investigational drug within less than or equal to 6 weeks prior to the first dose
of the current therapy with PEGASYS® plus COPEGUS®
• Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)
• History or other evidence of decompensated liver disease (Coagulopathy,
hyperbilirubinemia, hepatic encephalopathy, hypo-albuminemia, ascites, and
bleeding from esophageal varices are conditions consistent with
decompensated liver disease)
• Signs or symptoms of hepatocellular carcinoma
• Not adequately controlled thyroid dysfunction, diabetes mellitus or psychiatric
disorders
• Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or
clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or
hypertension)
• Any form of substance abuse (including excessive alcohol consumption) that
precludes successful participation in the study at the discretion of the investigator
• Inability or unwillingness to provide written informed consent or abide by the
requirements of the study
Exclusion Criteria at Randomization (treatment week 24):
• Patients who did NOT achieve an early virological response at week 12 (EVR
defined as undetectable HCV RNA or a drop of =2-log10 measured 71 to 98 days
after start of treatment)
• Neutrophil count <500 cells/mm3 or platelet count <25,000 cells/mm3 or
hemoglobin <8.5 g/dL
• Patients who discontinued study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method