Clinical trial NCT01651351: GLASSIA Infusion Rate Study
Official title: A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alpha1-antitrypsin Deficiency
Healthy Volunteers
Keywords: for this study
volunteers
Focus
Condition:
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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)
timeFrame: Day 1 and Day 15
Secondary outcomes:
measure: Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion
timeFrame: Within 1 hour of infusion completion
measure: Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion
timeFrame: Within 24 hours of the end of infusion
measure: Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion
timeFrame: Within 72 hours of the end of infusion
measure: Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion
timeFrame: Day 1 and Day 15
measure: Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion
timeFrame: 72 hours post infusion to 14 days post infusion
measure: 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
timeFrame: 105 days
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: