Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685AM3)(COMPLETED)

This study has been completed.

Study NCT00265395 Information provided by Schering-Plough

First Received: December 13, 2005 Last Updated: October 28, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Hepatitis C, Chronic
Interventions:	Drug: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) Drug: Combination of pegylated interferon alfa-2b and ribavirin

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
1428 patients enrolled; 159 patients qualified as slow responders per treatment week 12 and 24 protocol-specified eligibility criteria; 159 patients were randomized

Reporting Groups

	Description
Standard Therapy (48-week Treatment)	Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
Extended Therapy (72-week Treatment)	Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.

Participant Flow: Overall Study

	Standard Therapy (48-week Treatment)	Extended Therapy (72-week Treatment)
STARTED	86	73
COMPLETED	78	56
NOT COMPLETED	8	17
Adverse Event	3	6
Lost to Follow-up	2	1
Withdrawal by Subject	1	6
Protocol Violation	2	2
Lack of Efficacy	0	1
Administrative	0	1

Baseline Characteristics

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Reporting Groups

	Description
Standard Therapy (48-week Treatment)	Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
Extended Therapy (72-week Treatment)	Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.

Baseline Measures

	Standard Therapy (48-week Treatment)	Extended Therapy (72-week Treatment)	Total
Number of Participants [units: participants]	86	73	159
Age [units: years] Mean ± Standard Deviation	44.5 ± 9.9	46.5 ± 11.6	45.35 ± 10.79
Gender [units: participants]
Female	34	27	61
Male	52	46	98

Outcome Measures

1. Primary:

Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. [ 48 or 72 weeks of treatment plus 24 weeks of follow-up. ]

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