Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548AM2)(COMPLETED)

This study has been completed.

Study NCT00302081 Information provided by Schering-Plough

First Received on March 10, 2006. Last Updated on April 8, 2010 History of Changes

Results First Received: April 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
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
696 subjects were randomized. 14 subjects never received any study drug and, therefore, were excluded from the Intent to Treat (ITT) population. ITT population consisted of 682 subjects.

Reporting Groups

	Description
PEG2b 1.5/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
PEG2b 1.0/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
PEG2b 1.5/R (16 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

Participant Flow: Overall Study

	PEG2b 1.5/R (24 Weeks)	PEG2b 1.0/R (24 Weeks)	PEG2b 1.5/R (16 Weeks)
STARTED	237	229	230
COMPLETED	181	186	178
NOT COMPLETED	56	43	52
Adverse Event	6	5	4
Lost to Follow-up	21	18	28
Withdrawal by Subject	8	12	8
Protocol Violation	5	1	2
Lack of Efficacy	1	0	5
Death	2	1	0
Other	13	6	5

Baseline Characteristics

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Reporting Groups

	Description
PEG2b 1.5/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
PEG2b 1.0/R (24 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
PEG2b 1.5/R (16 Weeks)	PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

Baseline Measures

	PEG2b 1.5/R (24 Weeks)	PEG2b 1.0/R (24 Weeks)	PEG2b 1.5/R (16 Weeks)	Total
Number of Participants [units: participants]	230	224	228	682
Age [units: years] Mean ± Standard Deviation	38.8 ± 10.2	39.9 ± 11.2	39.7 ± 11.1	39.5 ± 10.9
Gender [units: participants]
Female	91	78	80	249
Male	139	146	148	433

Outcome Measures

1. Primary:

The Number of Participants Who Achieve a Sustained Virologic Response (SVR) [ Time Frame: 24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm. ]

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2. Secondary:

Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up. [ Time Frame: End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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 by Schering-Plough

Publications automatically indexed to this study:

Manns M, Zeuzem S, Sood A, Lurie Y, Cornberg M, Klinker H, Buggisch P, Rössle M, Hinrichsen H, Merican I, Ilan Y, Mauss S, Abu-Mouch S, Horban A, Müller TH, Welsch C, Chen R, Faruqi R, Pedicone LD, Wedemeyer H. Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C. J Hepatol. 2011 Sep;55(3):554-63. Epub 2011 Jan 13.

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00302081 History of Changes
Other Study ID Numbers:	P03548
Study First Received:	March 10, 2006
Results First Received:	April 29, 2009
Last Updated:	April 8, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Israel: Ministry of Health; India: Drugs Controller General of India; Poland: Ministry of Health; Indonesia: National Agency for Drug and Food Control; Singapore: Health Sciences Authority; Malaysia: Ministry of Health; Thailand: Thai Drug Control Division, Food and Drug Administration, Ministry of Public Health