Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548AM2)(COMPLETED)

This study has been completed.

Study NCT00302081 Information provided by Schering-Plough

First Received: March 10, 2006 Last Updated: June 24, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Parallel Assignment
Condition:	Hepatitis C, Chronic
Interventions:	Biological: peginterferon alfa-2b (SCH 54031) Drug: ribavirin (SCH 18908)

Participant Flow

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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
696 subjects were randomized. 14 subjects never received any study drug and, therefore, were excluded from the Intent to Treat (ITT) population. ITT population consisted of 682 subjects.

Reporting Groups

	Description
PEG2b 1.5/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
PEG2b 1.0/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
PEG2b 1.5/R (16 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

Participant Flow: Overall Study

	PEG2b 1.5/R (24 Weeks)	PEG2b 1.0/R (24 Weeks)	PEG2b 1.5/R (16 Weeks)
STARTED	237	229	230
COMPLETED	181	186	178
NOT COMPLETED	56	43	52
Adverse Event	6	5	4
Lost to Follow-up	21	18	28
Withdrawal by Subject	8	12	8
Protocol Violation	5	1	2
Lack of Efficacy	1	0	5
Death	2	1	0
Other	13	6	5

Baseline Characteristics

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Reporting Groups

	Description
PEG2b 1.5/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
PEG2b 1.0/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
PEG2b 1.5/R (16 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

Baseline Measures

	PEG2b 1.5/R (24 Weeks)	PEG2b 1.0/R (24 Weeks)	PEG2b 1.5/R (16 Weeks)	Total
Number of Participants [units: participants]	230	224	228	682
Age [units: years] Mean ± Standard Deviation	38.8 ± 10.2	39.9 ± 11.2	39.7 ± 11.1	39.5 ± 10.9
Gender [units: participants]
Female	91	78	80	249
Male	139	146	148	433

Outcome Measures

1. Primary:

The Number of Participants Who Achieve a Sustained Virologic Response (SVR) [ 24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm. ]

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