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GLASSIA Infusion Rate Study

Primary Purpose

Alpha1-antitrypsin Deficiency, Healthy Volunteers

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Alpha1-proteinase inhibitor

Placebo: Human albumin 2.5%

About this trial

This is an interventional treatment trial for Alpha1-antitrypsin Deficiency focused on measuring for this study, volunteers, Focus, Condition:

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Arm 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

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

Outcomes

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)

Secondary Outcome Measures

Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or 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

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

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

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

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

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

Number of participants with seroconversion

Full Information

NCT ID

NCT01651351

First Posted

July 23, 2012

Last Updated

May 3, 2021

Sponsor

Baxalta now part of Shire

1. Study Identification

Unique Protocol Identification Number

NCT01651351

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 31, 2012 (Actual)

Primary Completion Date

January 16, 2013 (Actual)

Study Completion Date

January 16, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxalta now part of Shire

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alpha1-antitrypsin Deficiency, Healthy Volunteers

Keywords

for this study, volunteers, Focus, Condition:

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm 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

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Alpha1-proteinase inhibitor

Other Intervention Name(s)

GLASSIA

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo: Human albumin 2.5%

Intervention Description

Intravenous administration

Primary Outcome Measure Information:

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)

Time Frame

Day 1 and Day 15

Secondary Outcome Measure Information:

Title

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

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

Title

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

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

Title

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

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

Title

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

Description

Number of AEs that occurred during an infusion and were deemed related to study product administration

Time Frame

Day 1 and Day 15

Title

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

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

Title

Description

Number of participants with seroconversion

Time Frame

105 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

12. IPD Sharing Statement

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GLASSIA Infusion Rate Study

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