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Study of the Safety of HPN-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyperion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00947297
First received: July 24, 2009
Last updated: July 15, 2013
Last verified: July 2013
Results First Received: April 30, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urea Cycle Disorders
Intervention: Drug: HPN-100

  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
No text entered.

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
HPN-100 Patients who were treated with HPN-100

Participant Flow:   Overall Study
    HPN-100  
STARTED     60  
COMPLETED     53  
NOT COMPLETED     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HPN-100 Patients who were treated with HPN-100

Baseline Measures
    HPN-100  
Number of Participants  
[units: participants]
  60  
Age  
[units: participants]
 
<=18 years     9  
Between 18 and 65 years     51  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.83  ± 13.933  
Gender  
[units: participants]
 
Female     41  
Male     19  
Region of Enrollment  
[units: participants]
 
United States     54  
Canada     6  



  Outcome Measures
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1.  Primary:   Rate of Adverse Events (Number of Participants Who Experienced Any AE Considered Related to Study Drug)   [ Time Frame: 1 year ]

2.  Secondary:   Number and Causes of Hyperammonemic Events   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tristen Moors - Associate Director, Clinical Operations
Organization: Hyperion Therapeutics
phone: 650-745-7840
e-mail: tristen.moors@hyperiontx.com


No publications provided by Hyperion Therapeutics, Inc.

Publications automatically indexed to this study:

Responsible Party: Hyperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00947297     History of Changes
Other Study ID Numbers: HPN-100-007
Study First Received: July 24, 2009
Results First Received: April 30, 2013
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration