PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370AM2)(COMPLETED)

This study has been completed.

Study NCT00039871 Information provided by Schering-Plough

First Received: June 13, 2002 Last Updated: October 13, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions:	Hepatitis Hepatitis C, Chronic Fibrosis Liver Cirrhosis
Interventions:	Biological: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: REBETOL (ribavirin; SCH 18908)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolled 2333; 21 subjects excluded due to Good Clinical Practice (GCP) non-compliance.

Reporting Groups

	Description
PegIntron Plus Rebetol	No text entered.

Participant Flow: Overall Study

	PegIntron Plus Rebetol
STARTED	2312^[1]
COMPLETED	928
NOT COMPLETED	1384
Adverse Event	165
Lost to Follow-up	18
Protocol Violation	24
Withdrawal by Subject	97
Did not meet eligibility criteria	11
Administrative	1
Discontinued at Week 12 per protocol	1061
Never entered follow-up	7

[1]	Enrolled 2333; 21 subjects excluded due to GCP non-compliance

Baseline Characteristics

Reporting Groups

	Description
PegIntron Plus Rebetol	No text entered.

Baseline Measures

	PegIntron Plus Rebetol
Number of Participants [units: participants]	2312
Age [units: number of subjects]
<=18 years	0
Between 18 and 65 years	2267
>=65 years	45
Age [units: years] Mean ± Standard Deviation	49.2 ± 8.1
Gender [units: number of subjects]
Female	662
Male	1650
Hepatitis C Virus (HCV) Genotype [units: number of participants]
Genotype 1	1859
Genotype 2	75
Genotype 3	293
Genotype 4	68
Nontypable	8
Missing	9
METAVIR Fibrosis score^[1] [units: number of participants]
F1	2
F2	658
F3	676
F4	974
Missing	2

[1]	The METAVIR scoring system for hepatic fibrosis is as follows: F0= no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3= septal fibrosis without cirrhosis F4= cirrhosis

Outcome Measures

1. Primary:

Sustained Virologic Response (SVR) Rate [ Assessed at end of 24 weeks posttreatment follow-up ]

Show Outcome Measure 1

2. Secondary:

Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 [ 24 weeks posttreatment ]

Show Outcome Measure 2

3. Secondary:

Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 [ 24 weeks posttreatment ]

Show Outcome Measure 3