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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Measure Type	Primary
Measure Title	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.
Measure Description	LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)
Time Frame	48 or 72 weeks of treatment plus 24 weeks of follow-up.
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.
According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24).

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.

Measured Values

	Standard Therapy (48-week Treatment)	Extended Therapy (72-week Treatment)
Number of Participants Analyzed [units: participants]	86	73
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. [units: Participants]	37	35

Statistical Analysis 1 for 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.

Groups ^[1]	All groups
Method ^[2]	Asymptotic Z-test
P Value ^[3]	0.6445
SVR Rate Difference ^[4]	-4.9
95% Confidence Interval	( -20.4 to 10.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	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
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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