Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

This study has been completed.

Sponsor:

Information provided by:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00289536

First received: February 9, 2006

Last updated: May 4, 2011

Last verified: May 2011

History of Changes

Results First Received: September 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hemophilia A
Intervention:	Biological: Antihemophilic factor, recombinant, manufactured protein-free

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
Recruitment was conducted in the United States at 8 study sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened for a maximum of 30 days. Participants were randomized to a single sequence of the 3 doses of Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM). Before each pharmacokinetic evaluation, at least a 3 day washout period and negative factor VIII inhibitor titer was required.

Reporting Groups

	Description
Low Dose	15 IU/kg rAHF-PFM
Medium Dose	30 IU/kg rAHF-PFM
High Dose	50 IU/kg rAHF-PFM

Participant Flow for 3 periods

Period 1: Period 1

	Low Dose	Medium Dose	High Dose
STARTED	9	8	9
COMPLETED	9	8	9
NOT COMPLETED	0	0	0

Period 2: Period 2

	Low Dose	Medium Dose	High Dose
STARTED	10 ^[1]	9 ^[2]	7 ^[3]
COMPLETED	10	9	7
NOT COMPLETED	0	0	0

[1]	5 participants received Medium Dose and 5 participants received High Dose in Period 1
[2]	5 participants received Low Dose and 4 participants received High Dose in Period 1
[3]	4 participants received Low Dose and 3 participants received Medium Dose in Period 1

Period 3: Period 3

	Low Dose	Medium Dose	High Dose
STARTED	7 ^[1]	9 ^[2]	10 ^[3]
COMPLETED	7	9	9
NOT COMPLETED	0	0	1
Lost to Follow-up	0	0	1

[1]	3 participants received Medium Dose and 4 participants received High Dose in Period 2
[2]	5 participants received Low Dose and 4 participants received High Dose in Period 2
[3]	5 participants received Low Dose and 5 participants received Medium Dose in Period 2

Baseline Characteristics

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Reporting Groups

	Description
Treated Participants	Participants who received at least 1 infusion of rAHF-PFM.

Baseline Measures

	Treated Participants
Number of Participants [units: participants]	26
Age [units: participants]
<=18 years	7
Between 18 and 65 years	19
>=65 years	0
Age [units: years] Mean ± Standard Deviation	23.8 ± 9.6
Gender [units: participants]
Female	0
Male	26
Region of Enrollment [units: participants]
United States	26

Outcome Measures

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1. Primary:

Initial Recovery [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion ]

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2. Secondary:

Area Under the Curve/Dose [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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3. Secondary:

Terminal Half-life [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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4. Secondary:

Area Under the Curve [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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5. Secondary:

Total Area Under the Curve [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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6. Secondary:

Total Area Under the Moment Curve [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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7. Secondary:

Weight-adjusted Clearance [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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8. Secondary:

Mean Residence Time [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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9. Secondary:

Volume of Distribution at Steady State [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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10. Secondary:

Maximum Plasma Concentration [ Time Frame: Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion ]

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11. Secondary:

Pre-infusion Von Willebrand Factor Ristocetin Cofactor Activity (VWF:Rco) [ Time Frame: At baseline and before each pharmacokinetic evaluation ]

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12. Secondary:

Pre-infusion Von Willebrand Factor Antigen (VWF:Ag) [ Time Frame: At baseline and before each pharmacokinetic evaluation ]

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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: Baxter’s agreements with PIs vary per individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥45 days prior to submission or communication. Baxter may request an additional delay of up to 60 days (e.g., to allow for intellectual property protection).

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: Wing-Yen Wong, MD, Global Sr Medical Dir Hemophilia
Organization: Baxter Healthcare Corporation
e-mail: wing_yen_wong@baxter.com

No publications provided

Responsible Party:	Jorge Escobar, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00289536 History of Changes
Other Study ID Numbers:	060403
Study First Received:	February 9, 2006
Results First Received:	September 30, 2010
Last Updated:	May 4, 2011
Health Authority:	United States: Food and Drug Administration

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