In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
sc weekly
iv weekly
sc twice weekly
iv twice weekly
Unnamed facility
Berlin, Germany
Unnamed facility
Frankfurt am Main, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Leipzig, Germany
HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration
Time frame: 11 months
Evaluation of predictors of response to i.v. treatment
Time frame: 11 months
Effect of waist to hip ratio on pharmacokinetics
Time frame: 11 months
Effect of waist to hip ratio on viral response
Time frame: 11 months
Incidence of adverse events
Time frame: 11 months
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