GLASSIA Infusion Rate Study

NCT01651351 | Completed Phase 4 Results

• 1 other identifier: 471201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alpha1-antitrypsin Deficiency; Healthy Volunteers

Keywords

for this study; volunteers; Focus; Condition:

Outcome Measures

Primary Outcomes (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)

  Day 1 and Day 15

Secondary Outcomes (6)

• Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion

  Within 1 hour of infusion completion

• Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion

  Within 24 hours of the end of infusion

• Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion

  Within 72 hours of the end of infusion

• Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion

  Day 1 and Day 15

• Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion

  72 hours post infusion to 14 days post infusion

Study Arms (2)

Cohort 1

EXPERIMENTAL

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; Biological: Placebo: Human albumin 2.5%

Cohort 2

EXPERIMENTAL

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; Biological: Placebo: Human albumin 2.5%

Interventions

Alpha1-proteinase inhibitor BIOLOGICAL

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

Also known as: GLASSIA

Cohort 1; Cohort 2

Placebo: Human albumin 2.5% BIOLOGICAL

Intravenous administration

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency; Disease

Interventions

alpha 1-Antitrypsin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Proteins; Alpha-Globulins; Serum Globulins; Globulins

Limitations and Caveats

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.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 27, 2012
• Study Start: July 31, 2012
• Primary Completion: January 16, 2013
• Study Completion: January 16, 2013
• Last Updated: May 25, 2021
• Results First Posted: May 29, 2014

Record last verified: 2021-05

Locations

US (1)