Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00687544

First received: May 27, 2008

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

Results First Received: September 22, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Hepatitis C, Chronic Hepacivirus HIV Infections
Interventions:	Biological: Peginterferon alfa-2b (SCH 054031) Drug: Ribavirin (SCH 018908)

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-IFN + RBV	Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Participant Flow: Overall Study

	PEG-IFN + RBV
STARTED	11
COMPLETED	0
NOT COMPLETED	11

Baseline Characteristics

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Reporting Groups

	Description
PEG-IFN + RBV	Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Baseline Measures

	PEG-IFN + RBV
Number of Participants [units: participants]	11
Age [units: Participants]
<=18 years	0
Between 18 and 65 years	11
>=65 years	0
Gender [units: participants]
Female	0
Male	11
Region of Enrollment [units: participants]
Indonesia	11

Outcome Measures

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1. Primary:

Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: Week 48 or Week 72 (depending on duration of treatment) ]

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2. Primary:

Number of Participants Who Achieved Virologic Response (VR) [ Time Frame: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks) ]

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3. Primary:

Number of Participants Who Achieved Sustained Biochemical Response (SBR) [ Time Frame: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks) ]

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4. Secondary:

Number of Participants Experiencing Opportunistic Infection [ Time Frame: Throughout the study (up to 72 weeks) ]

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5. Secondary:

Number of Participants Who Died [ Time Frame: Throughout the study (up to 72 weeks) ]

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6. Secondary:

Number of Participants Experiencing Adverse Events [ Time Frame: Throughout the study (up to 72 weeks) ]

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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. Restriction Description: The Principal Investigator agrees not to publish/present any interim results without sponsor's prior written consent and agrees to provide sponsor 45 days written notice prior to submission for publication/presentation to permit the sponsor to review copies. The sponsor shall have the right to review and comment, including editing.

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
The study was terminated early due to low enrollment. The primary and secondary outcomes were not evaluated. A formal safety analysis was not performed for the 11 participants enrolled in the study.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00687544 History of Changes
Other Study ID Numbers:	P04469
Study First Received:	May 27, 2008
Results First Received:	September 22, 2011
Last Updated:	December 22, 2011
Health Authority:	Indonesia: National Agency of Drug and Food Control

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