Chronic hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Trade Name: Pegasys
Product Name: Peginterferon alpha-2a
Product Code: Ro 25-8310/J13 & V01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2a
CAS Number: 198153-51
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 mesuared 71 to 98 days after start of treatment) - Neutrophil count <500cells/mm3 or platelet count <25,000 cells/mm3 or hemoglobin <8.5 g/dl - Patients who discontinued study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus COPEGUS® (ribavirin) combination therapy given for 24 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end (sustained virological response, SVR) in patients with chronic hepatitis C (CHC) virus infection and Genotype 2/3, who do not achieve a rapid viral response (RVR, defined as undetectable HCV RNA by the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at week 4 but have an early virological response at week 12 (EVR, defined as undetectable HCV RNA or a drop of =2-log10);Secondary Objective: - To evaluate the effect of PEGASYS plus COPEGUS combination therapy given for 24 weeks versus 48 weeks on the clearance of HCV viremia 72 weeks after treatment initiation (FDA request) - To compare the effect of PEGASYS® plus COPEGUS® given for 24 weeks versus 48 weeks on end of treatment response and relapse rates - To evaluate prognostic factors for sustained virological response and relapse in the two randomized treatment groups - To compare the safety of PEGASYS plus COPEGUS given for 24 versus 48 weeks - To investigate the impact of the COPEGUS® starting dose (800 mg/d versus 1000/1200 mg/d in combination with PEGASYS®) on virological response - To describe the safety of PEGASYS plus COPEGUS at a starting dose of 800 mg/d versus 2000/1200 mg/d - Pharmacoeconomic evaluation and comparison of the two study arms;Primary end point(s): Sustained virological response (SVR) defined as percentage of patients with undetectable HCV RNA as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 24 and 48 week treatment periods (a single last HCV RNA PCR measured =day 308 after treatment initiation for patients not randomized or from group A and =day 477 for group B) | — |
Countries
Austria, Belgium, Germany
Outcome results
None listed