Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538AM1 Part 1)(COMPLETED)

This study has been completed.

Study NCT00104052 Information provided by Schering-Plough

First Received: February 22, 2005 Last Updated: October 13, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group 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
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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

Baseline Characteristics

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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.

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

Outcome Measures

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. ]

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Measure Type	Primary
Measure Title	Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment
Measure Description	SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment
Time Frame	Up to 48-week treatment duration. Follow-up of 24 weeks.
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Carry Forward analysis of participants who received at least one dose of study medication. This dataset includes one subject with undetectable HCV-RNA at Follow-up Week 12 (FW 12) but missing data at FW 24; this subject was considered a sustained responder in the Carry Forward analysis.

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.

Measured Values

	PEG-Intron Plus REBETOL
Number of Participants Analyzed [units: participants]	107
Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment [units: Participants]	70

Statistical Analysis 1 for Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment

Groups ^[1]	PEG-Intron Plus REBETOL
Normal approximation to the binomial ^[2]	0.654
95% Confidence Interval	( 0.564 to 0.744 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant estimation information:
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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
NONE

Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02538: Part 1
Study First Received:	February 22, 2005
Results First Received:	November 14, 2008
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00104052 History of Changes
Health Authority:	United States: Food and Drug Administration