Phase 4
Completed N=30
GLASSIA Infusion Rate Study
Alpha1-antitrypsin Deficiency · Healthy Volunteers
Source: ClinicalTrials.gov NCT01651351 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: 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) — 0; 0 Infusions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
0; 0 | — |
| SECONDARY Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion |
3; 1 | — |
| SECONDARY Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion |
5; 3 | — |
| SECONDARY Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion |
7; 5 | — |
| SECONDARY Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion |
1; 0 | — |
| SECONDARY Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion |
0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0 | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT01651351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.