Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed) (RE-CHUT)

This study has been terminated.

(Low enrollment)

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00725842

First received: July 28, 2008

Last updated: June 25, 2012

Last verified: June 2012

History of Changes

Results First Received: June 13, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Hepatitis C Hepatitis C, Chronic
Interventions:	Biological: Peg-IFN alfa-2b Drug: 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
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Reporting Groups

	Description
Peg-IFN Alfa-2b + Ribavirin	Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).

Participant Flow: Overall Study

	Peg-IFN Alfa-2b + Ribavirin
STARTED	97
Participants Eligible for Analysis	90
COMPLETED	57
NOT COMPLETED	40
Lost to Follow-up	19
Death	1
Positive HCV-RNA at Visit 2	13
Consent date prior to study start date	5
Inclusion criterion not met	1
No Visit 1 data	1

Baseline Characteristics

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Reporting Groups

	Description
Peg-IFN Alfa-2b + Ribavirin	Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).

Baseline Measures

	Peg-IFN Alfa-2b + Ribavirin
Number of Participants [units: participants]	90
Age ^[1] [units: years] Mean ± Standard Deviation	46.0 ± 12.5
Gender ^[2] [units: participants]
Female	25
Male	65

[1]	Age data unavailable for the 7 participants excluded from analysis.
[2]	Gender data unavailable for the 7 participants excluded from analysis.

Outcome Measures

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1. Primary:

Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment [ Time Frame: 24 weeks post end of treatment (EOT) ]

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2. Secondary:

Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment [ Time Frame: 24 weeks post EOT ]

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3. Secondary:

Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response [ Time Frame: Baseline and 24 weeks post EOT ]

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4. Secondary:

Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment [ Time Frame: 72 weeks post EOT ]

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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: Study data disclosure is prohibited; data and study results are the exclusive property of the Sponsor.

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
Due to low enrollment some planned analyses were not performed.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00725842 History of Changes
Other Study ID Numbers:	P05484
Study First Received:	July 28, 2008
Results First Received:	June 13, 2012
Last Updated:	June 25, 2012
Health Authority:	France: Physicians National Council

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