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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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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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
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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:	P03685, SUCCESS
Study First Received:	December 13, 2005
Results First Received:	May 15, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00265395 History of Changes
Health Authority:	Spain: Ethics Committee