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GLASSIA Infusion Rate Study

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alpha1-antitrypsin Deficiency; Healthy

Intervention: Alpha1-proteinase inhibitor (Biological); Placebo: Human albumin 2.5% (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Leman Yel, MD, Study Director, Affiliation: Baxter Healthcare Corporation

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.

Clinical Details

Official title: A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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:

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 Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion

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

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

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

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

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Overland Park, Kansas 66211, United States
Additional Information

Starting date: July 2012
Last updated: June 26, 2015

Page last updated: August 23, 2015

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