ClinicalTrials.gov
ClinicalTrials.gov Menu

GLASSIA Infusion Rate Study

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.
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%
Enrollment 30

Recruitment Details Recruitment was conducted in the U.S at 1 study site. The first participant was enrolled in July 2012.
Pre-assignment Details 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.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
Safety Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
27  (8) 29  (13) 28  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
3
  20.0%
4
  26.7%
7
  23.3%
Male
12
  80.0%
11
  73.3%
23
  76.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Day 1 and Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Infusions
0 0
2.Secondary Outcome
Title Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion
Hide Description Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment
Time Frame Within 1 hour of infusion completion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Infusions
3 1
3.Secondary Outcome
Title Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion
Hide Description Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment
Time Frame Within 24 hours of the end of infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Infusions
5 3
4.Secondary Outcome
Title Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion
Hide Description Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment
Time Frame Within 72 hours of the end of infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Infusions
7 5
5.Secondary Outcome
Title Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion
Hide Description Number of AEs that occurred during an infusion and were deemed related to study product administration
Time Frame Day 1 and Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: adverse events
1 0
6.Secondary Outcome
Title Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion
Hide Description Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration
Time Frame 72 hours post infusion to 14 days post infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: adverse events
0 0
7.Secondary Outcome
Title 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
Hide Description Number of participants with seroconversion
Time Frame 105 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title All Study Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
HAV 0
HBV 0
HCV 0
PVB19 0
HIV 0
Time Frame Throughout the study period of 105 days per participant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GLASSIA Infusion Rate- 0.04 mL/kg/Min GLASSIA Infusion Rate- 0.2 mL/kg/Min
Hide Arm/Group Description

Participants who received simultaneous infusions of:

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

Participants who received simultaneous infusions of:

  • GLASSIA at 0.2 mL/kg/min
  • Placebo at 0.04 mL/kg/min
All-Cause Mortality
GLASSIA Infusion Rate- 0.04 mL/kg/Min GLASSIA Infusion Rate- 0.2 mL/kg/Min
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GLASSIA Infusion Rate- 0.04 mL/kg/Min GLASSIA Infusion Rate- 0.2 mL/kg/Min
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GLASSIA Infusion Rate- 0.04 mL/kg/Min GLASSIA Infusion Rate- 0.2 mL/kg/Min
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/30 (26.67%)      4/30 (13.33%)    
Musculoskeletal and connective tissue disorders     
Back Pain  1/30 (3.33%)  1 2/30 (6.67%)  2
Pain In Extremity  2/30 (6.67%)  2 0/30 (0.00%)  0
Nervous system disorders     
Headache  6/30 (20.00%)  7 3/30 (10.00%)  5
Dizziness  2/30 (6.67%)  2 1/30 (3.33%)  1
1
Term from vocabulary, MedDRA (Unspecified)
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.
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.
PI may not publish without the prior written consent of Sponsor
Results Point of Contact
Name/Title: Leman Yel, MD, Medical Director, Biotherapeutics
Organization: Baxter Healthcare Corporation
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