Alpha1-antitrypsin DeficiencyPhase 4NCT01651351
GLASSIA Infusion Rate Study
A Phase 4 study testing Alpha1-proteinase inhibitor in people with Alpha1-antitrypsin Deficiency and Healthy Volunteers, run by Baxalta now part of Shire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alpha1-antitrypsin Deficiency, Healthy Volunteers
- What is being tested?
- Alpha1-proteinase inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2012to 16 Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers
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.
Read the 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.
- Conditions
- Alpha1-antitrypsin Deficiency, Healthy Volunteers
- Being tested
- Alpha1-proteinase inhibitor, Placebo: Human albumin 2.5%
- Keywords
- for this study, volunteers, Focus, Condition:
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha1-proteinase inhibitorBiological
Also called GLASSIA
GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.
Placebo: Human albumin 2.5%Biological
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Alpha1-proteinase inhibitor; Biological: Placebo: Human albumin 2.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment
Measured: 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 AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment
Measured: 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
Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment
Measured: Within 72 hours of the end of infusion
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
Measured: Day 1 and Day 15
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
Measured: 72 hours post infusion to 14 days post 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
Number of participants with seroconversion
Measured: 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study start31 Jul 2012
- Primary completion16 Jan 2013
- Study completion16 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alpha1-antitrypsin DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651351
- Sponsor's protocol ID
- 471201
- Status last verified
- May 2021
- First submitted
- 23 Jul 2012
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01651351
- Acronym / sponsor ID
- 471201
- Conditions
- Alpha1-antitrypsin Deficiency, Healthy Volunteers
- Keywords
- for this study, volunteers, Focus, Condition:
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2012 (actual)
- Primary completion
- 16 Jan 2013 (actual)
- Study completion
- 16 Jan 2013 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Posted 29 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Alpha1-proteinase inhibitor, Biological: Placebo: Human albumin 2.5%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 |
| Cohort 2 | Experimental | Biological: Alpha1-proteinase inhibitor, Biological: Placebo: Human albumin 2.5%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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha1-proteinase inhibitorAlso: GLASSIAGLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. | Biological | Cohort 1, Cohort 2 |
| Placebo: Human albumin 2.5%Intravenous administration | Biological | Cohort 1, Cohort 2 |
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)
Time frame: Day 1 and Day 15
6 secondary outcomes
Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion
Time frame: 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
Time frame: 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
Time frame: Within 72 hours of the end of infusion
Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion
Time frame: Day 1 and Day 15
Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion
Time frame: 72 hours post infusion to 14 days post 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
Time frame: 105 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha1-proteinase inhibitor in people with Alpha1-antitrypsin Deficiency and Healthy Volunteers, run by Baxalta now part of Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 1 and Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.