Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

This study has been completed.

Study NCT00675103 Information provided by Savient Pharmaceuticals

First Received on May 6, 2008. Last Updated on June 7, 2011 History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Gout Refractory to Conventional Therapy
Intervention:	Drug: pegloticase 8 mg i.v.

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
Pegloticase 8 mg Every 2 Wks	No text entered.

Participant Flow: Overall Study

	Pegloticase 8 mg Every 2 Wks
STARTED	7
COMPLETED	4
NOT COMPLETED	3
Lack of Efficacy	2
Adverse Event	1

Baseline Characteristics

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Reporting Groups

	Description
Pegloticase 8 mg Every 2 Wks	No text entered.

Baseline Measures

	Pegloticase 8 mg Every 2 Wks
Number of Participants [units: participants]	7
Age [units: participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	3
Age [units: years] Mean ± Standard Deviation	66.4 ± 8.77
Gender [units: participants]
Female	1
Male	6
Region of Enrollment [units: participants]
United States	7

Outcome Measures

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1. Primary:

Adverse Event Profile [ Time Frame: 6 months ]

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2. Secondary:

Mean Plasma Uric Acid [ Time Frame: Baseline, Week 3 and Week 7 ]

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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.

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
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Savient Pharmaceuticals, Inc.
phone: 732-418-9300

No publications provided

Responsible Party:	Chief Medical Officer, Savient Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00675103 History of Changes
Other Study ID Numbers:	C0409
Study First Received:	May 6, 2008
Results First Received:	June 7, 2011
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration