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GLASSIA Infusion Rate Study

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ClinicalTrials.gov Identifier: NCT01651351
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : May 29, 2014
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Alpha1-antitrypsin Deficiency
Healthy Volunteers
Interventions: Biological: Alpha1-proteinase inhibitor
Biological: Placebo: Human albumin 2.5%

  Participant Flow

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 U.S at 1 study site. The first participant was enrolled in July 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty five healthy potential participants were enrolled at the clinical study site. Four were screen failures, and one was a back up participant who did not participate. Therefore, 30 participants were randomized.

Reporting Groups
  Description
Cohort 1

Day 1:

  • GLASSIA at 0.04 mL/kg/min
  • Placebo at 0.2 mL/kg/min

Day 15:

  • GLASSIA at 0.2 mL/kg/min
  • Placebo at 0.04 mL/kg/min

Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.

Placebo: Human albumin 2.5%: Intravenous administration

Cohort 2

Day 1:

  • GLASSIA at 0.2 mL/kg/min
  • Placebo at 0.04 mL/kg/min

Day 15:

  • GLASSIA at 0.04 mL/kg/min
  • Placebo at 0.2 mL/kg/min

Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.

Placebo: Human albumin 2.5%: Intravenous administration


Participant Flow:   Overall Study
    Cohort 1   Cohort 2
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics

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

Reporting Groups
  Description
Cohort 1

Day 1:

  • GLASSIA at 0.04 mL/kg/min
  • Placebo at 0.2 mL/kg/min

Day 15:

  • GLASSIA at 0.2 mL/kg/min
  • Placebo at 0.04 mL/kg/min

Placebo: Human albumin 2.5%: Intravenous administration

Cohort 2

Day 1:

  • GLASSIA at 0.2 mL/kg/min
  • Placebo at 0.04 mL/kg/min

Day 15:

  • GLASSIA at 0.04 mL/kg/min
  • Placebo at 0.2 mL/kg/min

Placebo: Human albumin 2.5%: Intravenous administration

Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 27  (8)   29  (13)   28  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  20.0%      4  26.7%      7  23.3% 
Male      12  80.0%      11  73.3%      23  76.7% 
Region of Enrollment 
[Units: Participants]
     
United States   15   15   30 


  Outcome Measures

1.  Primary:   Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)   [ Time Frame: Day 1 and Day 15 ]

2.  Secondary:   Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion   [ Time Frame: Within 1 hour of infusion completion ]

3.  Secondary:   Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion   [ Time Frame: Within 24 hours of the end of infusion ]

4.  Secondary:   Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion   [ Time Frame: Within 72 hours of the end of infusion ]

5.  Secondary:   Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion   [ Time Frame: Day 1 and Day 15 ]

6.  Secondary:   Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion   [ Time Frame: 72 hours post infusion to 14 days post infusion ]

7.  Secondary:   Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA   [ Time Frame: 105 days ]


  Serious Adverse Events


  Other Adverse Events


  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
Simultaneous infusion of GLASSIA and placebo did not allow adverse events (AEs) to be unquestionably ascribed to either one. Any observed AE which was assessed by the investigator as related to treatment was conservatively attributed to GLASSIA.


  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:
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: Leman Yel, MD, Medical Director, Biotherapeutics
Organization: Baxter Healthcare Corporation
e-mail: leman_yel@baxter.com



Responsible Party: Shire ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT01651351     History of Changes
Other Study ID Numbers: 471201
First Submitted: July 23, 2012
First Posted: July 27, 2012
Results First Submitted: April 29, 2014
Results First Posted: May 29, 2014
Last Update Posted: February 12, 2018