Study Evaluating Refacto For Pharmacovigilance

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00195442

First received: September 13, 2005

Last updated: February 7, 2011

Last verified: February 2011

History of Changes

Results First Received: January 12, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Hemophilia A
Intervention:	Drug: Moroctocog alfa

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
A total of 288 participants were observed during the study in 48 centers (44 Germany and 4 Austria) from time of First subject first visit May 1999 to Last subject last visit January 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was terminated January 2010 due to the introduction of a successor product ReFacto® AF.

Reporting Groups

	Description
ReFacto (Moroctocog Alfa)	B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.

Participant Flow: Overall Study

	ReFacto (Moroctocog Alfa)
STARTED	288
COMPLETED	152
NOT COMPLETED	136
Less than expected therapeutic effect	38
Lost to Follow-up	27
Switch to other Factor VIII preparation	23
Intermittent product shortage	21
Death	7
No reason specified	4
Poor cooperation	2
Unknown	14

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
ReFacto (Moroctocog Alfa)	B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.

Baseline Measures

	ReFacto (Moroctocog Alfa)
Number of Participants [units: participants]	288
Age, Customized [units: participants]
Children < 18 years of age	106
Adults ≥ 18 years of age	182
Gender [units: participants]
Female	0
Male	288

Outcome Measures

Show All Outcome Measures

1. Primary:

Mean Number of Bleeding Episodes Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 1

2. Primary:

Mean Number of Bleeding-related Exposure Days Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 2

3. Primary:

Mean Number of Exposure Days Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 3

4. Secondary:

Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 4

5. Secondary:

Number of Participants With de Novo Inhibitor Formation [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 5

6. Secondary:

Mean Annual ReFacto Consumption Per Patient Year [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 6

7. Secondary:

Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 7

8. Secondary:

Number of Participants for Physicians' Assessment of Efficacy [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 8

9. Secondary:

Number of Participants for Patients' Assessment of Efficacy [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 9

10. Secondary:

Number of Participants for Physicians' Assessment of Tolerance [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 10

11. Secondary:

Number of Participants for Patients' Assessment of Tolerance [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 11

12. Secondary:

Number of Participants for Physicians' Assessment of Handling of ReFacto [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 12

13. Secondary:

Number of Participants for Patients' Assessment of Handling of ReFacto [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 13

14. Secondary:

Number of Participants for Days of Sick Leave Per Month [ Time Frame: Baseline up to a mean duration of 54 months ]

Show Outcome Measure 14

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: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00195442 History of Changes
Other Study ID Numbers:	3082A-100690
Study First Received:	September 13, 2005
Results First Received:	January 12, 2011
Last Updated:	February 7, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut

To Top