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High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) (NGAM-05)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01313507
First Posted: March 11, 2011
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Octapharma
Results First Submitted: October 21, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Primary Immunodeficiency Disease
Intervention: Biological: NewGam

  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
NewGam Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).

Participant Flow:   Overall Study
    NewGam
STARTED   21 
COMPLETED   21 
NOT COMPLETED   0 



  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.
Safety analysis set: All participants who received at least 1 dose of NewGam.

Reporting Groups
  Description
NewGam Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).

Baseline Measures
   NewGam 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.8  (19.78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  38.1% 
Male      13  61.9% 


  Outcome Measures
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1.  Primary:   Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug   [ Time Frame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months) ]

2.  Primary:   Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug   [ Time Frame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months) ]

3.  Secondary:   Change From Baseline in the Quality of Life (QoL) at the End of the Study   [ Time Frame: Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months) ]


  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 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.


Results Point of Contact:  
Name/Title: Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine
Organization: Octapharma USA
phone: 201 604-1155
e-mail: michael.eppolito@octapharma.com



Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01313507     History of Changes
Other Study ID Numbers: NGAM-05
First Submitted: March 9, 2011
First Posted: March 11, 2011
Results First Submitted: October 21, 2015
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017