The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus. This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.
Study Type
OBSERVATIONAL
Enrollment
3
IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling
Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling
Incidence of serious adverse events
Time frame: After the inclusion of the subject in the study (defined as the time when the subject signs the informed consent) and up to 30 days after the subject completed or discontinued the study
Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)
Time frame: Assessed at the end of treatment and 24 weeks post-treatment
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