GLASSIA Infusion Rate Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01651351
First received: July 23, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Alpha1-antitrypsin Deficiency
Healthy
Biological: Alpha1-proteinase inhibitor
Biological: Placebo: Human albumin 2.5%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment

  • 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 ] [ Designated as safety issue: Yes ]
    Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment

  • 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 ] [ Designated as safety issue: Yes ]
    Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment

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

  • 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 ] [ Designated as safety issue: Yes ]
    Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration

  • 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 ] [ Designated as safety issue: Yes ]
    Number of participants with seroconversion


Enrollment: 30
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651351

Locations
United States, Kansas
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Leman Yel, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01651351     History of Changes
Other Study ID Numbers: 471201
Study First Received: July 23, 2012
Results First Received: April 29, 2014
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
Condition:
for this study
Focus
volunteers

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protease Inhibitors
Albunex
Trypsin Inhibitors
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 11, 2014