Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PEG-Intron Plus REBETOL	SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.

Participant Flow:   Overall Study

	PEG-Intron Plus REBETOL
STARTED	107
COMPLETED	78
NOT COMPLETED	29
Adverse Event	1
Lack of Efficacy	26
Discontinuation unrelated to treatment	2

Reporting Groups

	Description
PEG-Intron Plus REBETOL	SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.

Baseline Measures

	PEG-Intron Plus REBETOL
Number of Participants   [units: participants]	107
Age   [units: years] Mean ± Standard Deviation	9.7 ± 4.0
Gender   [units: participants]
Female	56
Male	51

1.  Primary:

Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment   [ Up to 48-week treatment duration. Follow-up of 24 weeks. ]