Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)(TERMINATED)

This study has been terminated.

(Slow enrollment)

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00255008

First received: November 15, 2005

Last updated: December 2, 2009

Last verified: December 2009

History of Changes

Results First Received: December 5, 2008

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 Drug: ribavirin

Participant Flow

Show Participant Flow

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Genotype 1 SEA PEG-IFN/RIB 48 w	Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
Genotype 1 Caucasian PEG-IFN/RIB 48 w	Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w	Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w	Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
Total	Total of all reporting groups

Baseline Measures

	Genotype 1 SEA PEG-IFN/RIB 48 w	Genotype 1 Caucasian PEG-IFN/RIB 48 w	Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w	Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w	Total
Number of Participants [units: participants]	45	9	33	34	121
Age [units: years] Mean ± Standard Deviation	43.6 ± 11.06	43.6 ± 12.30	46.8 ± 10.56	46.3 ± 10.71	45.2 ± 10.89
Gender [units: participants]
Female	19	4	15	12	50
Male	26	5	18	22	71

Outcome Measures

1. Primary:

Number of Subjects Who Achieved a Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after completion of either up to 24 or 48 weeks of therapy ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

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:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00255008 History of Changes
Other Study ID Numbers:	P04212
Study First Received:	November 15, 2005
Results First Received:	December 5, 2008
Last Updated:	December 2, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

To Top