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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 : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Description
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Brief Summary:
The purpose of this study was to generate sufficient safety and tolerability information in support of an increase in the infusion rate of intravenous GLASSIA in the prescribing information from 0.04 to 0.2 mL/kg/min.

Condition or disease Intervention/treatment Phase
Alpha1-antitrypsin Deficiency Healthy Volunteers Biological: Alpha1-proteinase inhibitor Biological: Placebo: Human albumin 2.5% Phase 4

Detailed Description:

To achieve proper masking, 30 participants were randomly assigned to receive either GLASSIA at 0.04 mL/kg/min with a simultaneous administration of placebo (2.5% human albumin in normal saline) at 0.2 mL/kg/min (Cohort 1) or GLASSIA at 0.2 mL/kg/min with a simultaneous administration of placebo at 0.04 mL/kg/min (Cohort 2) on Day 1.

Two weeks later (Day 15), the same participants received the second infusion with the opposite rate of GLASSIA infusion and the corresponding masking placebo infusion.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers
Actual Study Start Date : July 31, 2012
Actual Primary Completion Date : January 16, 2013
Actual Study Completion Date : January 16, 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Biological: 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.
Other Name: GLASSIA

Biological: Placebo: Human albumin 2.5%
Intravenous administration
Experimental: 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
 Biological: 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.
Other Name: GLASSIA

Biological: Placebo: Human albumin 2.5%
Intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment

  2. 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 ]
    Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment

  3. 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 ]
    Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment

  4. Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion [ Time Frame: Day 1 and Day 15 ]
    Number of AEs that occurred during an infusion and were deemed related to study product administration

  5. 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 ]
    Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration

  6. 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 ]
    Number of participants with seroconversion


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 18 to 65 years of age inclusive, at the time of screening
  • Body mass index (BMI) in the range of 19.0 to 32.0 kg/m2 (inclusive) and body weight >= 50 kg at the time of screening
  • Healthy subject with no clinical evidence of acute and/or chronic disease and no clinically significant abnormalities on hematology panel, clinical chemistry panel, urinalysis, or electrocardiogram (ECG) at the time of screening
  • Negative drug screen test at screening. Subject must agree to refrain from heavy alcohol consumption (defined as more than 2 drinks per day on a regular basis) and use of narcotic drugs or illegal substances for at least 2 weeks prior to screening and throughout the course of the study. Subject must also agree to drug screen testing at the discretion of the investigator at any time during the course of the study.
  • If female of childbearing potential, subject presents with a negative serum pregnancy test and agrees to employ adequate birth control measures for the duration of the study
  • If male, the subject must agree to use an acceptable form of birth control throughout the study and for at least 90 days after dosing. Additionally, the subject must agree to abstain from sperm donation for 90 days after the last administration of investigational product.
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Known history of OR positive serological evidence at the time of screening for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus B19 (PVB19) or human immunodeficiency virus (HIV) type 1/2 infection
  • Known history of hypersensitivity or adverse reactions (e.g. urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components
  • Documented immunoglobulin A (IgA) deficiency (<7 mg/dL at screening)
  • Evidence of uncontrolled hypertension (systolic blood pressure of >160 mm Hg, and/or diastolic blood pressure of >100 mm Hg despite anti-hypertensive medications)
  • Subject is nursing or intends to begin nursing during the course of the study
  • Subject has participated in a clinical trial and has received an investigational product within 60 days prior to screening
  • Subject has a planned medical procedure within the study period
  • Any clinically significant medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, may impede the subject's ability to comply with the study procedures, pose increased risk to the subject's safety, or confound the interpretation of study results
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651351


Locations
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United States, Kansas
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01651351    
Other Study ID Numbers: 471201
First Posted: July 27, 2012    Key Record Dates
Results First Posted: May 29, 2014
Last Update Posted: May 25, 2021
Last Verified: May 2021
Keywords provided by Takeda ( Baxalta now part of Shire ):
for this study
volunteers
Focus
Condition:
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
 Pathologic Processes
Protease Inhibitors
Alpha 1-Antitrypsin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors