Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011) (POMOSCH)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01098097

First received: April 1, 2010

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Results First Received: October 17, 2012

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Hepatitis C, Chronic
Interventions:	Biological: Peginterferon alpha Drug: Ribavirin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First participant enrolled: 9 February 2009; last participant completed: 17 October 2011. The study was conducted in 117 centers in 12 countries.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Peginterferon Alpha and Ribavirin	Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.

Participant Flow: Overall Study

	Peginterferon Alpha and Ribavirin
STARTED	963
COMPLETED	881 ^[1]
NOT COMPLETED	82
Adverse Event	17
Lost to Follow-up	18
Status unknown	16
No reason reported	31

[1]	Participants completing the study received at least 12 weeks of treatment

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Peginterferon Alpha and Ribavirin	Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.

Baseline Measures

	Peginterferon Alpha and Ribavirin
Number of Participants [units: participants]	963
Age [units: years] Median ( Full Range )	50 ( 18 to 78 )
Gender [units: participants]
Female	420
Male	543
Previous non-response type ^[1] [units: participants]
Null responder	346
Virologic breakthrough	67
Relapse	544
Previous non-response type not known	6

[1]	Participants in the study previously failed to respond with a sustained virologic response to treatment with interferon alpha with or without ribavirin. The type of previous non-response was categorized at study baseline.

Outcome Measures

Show All Outcome Measures

1. Primary:

Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) [ Time Frame: Up to 12 Weeks ]

Show Outcome Measure 1

2. Primary:

Incidence of Thrombocytopenia [ Time Frame: Up to 12 Weeks ]

Show Outcome Measure 2

3. Primary:

Incidence of Treatment Discontinuations Due to Adverse Events [ Time Frame: Up to 12 Weeks ]

Show Outcome Measure 3

4. Primary:

Incidence of Particular Adverse Events Resulting in Treatment Discontinuation [ Time Frame: Up to 12 Weeks ]

Show Outcome Measure 4

5. Primary:

Incidence of Dose Modifications Due to Adverse Events [ Time Frame: Up to 12 Weeks ]

Show Outcome Measure 5

6. Secondary:

Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) [ Time Frame: Week 12 ]

Show Outcome Measure 6

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. Restriction Description: The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts. Investigator agrees to meet with sponsor's representatives prior to submission for publication to discuss and resolve any disagreements.

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

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01098097 History of Changes
Other Study ID Numbers:	P06011
Study First Received:	April 1, 2010
Results First Received:	October 17, 2012
Last Updated:	October 17, 2012
Health Authority:	Russia: Ethics Committee at the Federal Service on Surveillance in Healthcare and Social Development

To Top