Chronic Obstructive Pulmonary DiseasePhase 3NCT02722304
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
A Phase 3 study testing ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg and GLASSIA 60 mg/kg in people with Chronic Obstructive Pulmonary Disease and Alpha1-antitrypsin Deficiency, run by Baxalta now part of Shire at 17 sites in 3 countries.
Trial summary
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency
- What is being tested?
- ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg and GLASSIA 60 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 2 Nov 2016to 14 Sep 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at the time of screening
- Endogenous plasma Alpha1-Proteinase Inhibitor (A1PI) level <8 μM at any time during the Screening period for treatment-naïve participants, or following 4-weeks minimum wash-out from previous augmentation therapy in treatment-experienced participants. The screening plasma A1PI level may be repeated if a participant obtains an exclusionary value that is suspected to be due to inadequate washout of A1PI).
- Participant has documented A1PI genotype of Pi*Z/Z, Pi*Z/Null, Pi*Malton/Z, Pi*Null/Null, or other rare genotypes (except PI*MS, PI*MZ, or PI*SZ).
- Clinically evident mild-moderate chronic obstructive pulmonary disease (COPD) (according to GOLD criteria for diagnosis) at the time of screening.
- If the participant is treated with any respiratory medications including inhaled bronchodilators, inhaled corticosteroids, or systemic corticosteroids (e.g. prednisone ≤ 10 mg/day or its equivalent), the doses of the participant's medications have remained stable for at least 28 days prior to screening.
- No clinically significant abnormalities (other than emphysema, bronchitis or bronchiectasis) detected via a chest computed tomography (CT) or chest X-ray at the time of screening.
- If female of childbearing potential, participant must have a negative pregnancy test at screening and agree to employ adequate birth control measures for the duration of the study.
- Participant is willing and able to comply with the requirements of the protocol.
Who cannot join
- Known ongoing or history of clinically significant pulmonary impairment other than emphysema/ COPD.
- The participant is experiencing lower respiratory infection (LRTI)/acute pulmonary exacerbation (APE) at the time of enrollment (signing Informed consent form (ICF)). Participant may be rescreened after both clinical resolution of LRTI/APE and having also remained stable for at least 4 weeks after the end of LRTI/APE).
- Known ongoing or history of cor pulmonale.
- Known resting partial pressure of carbon dioxide (PaCO2) levels of > 45 mmHg.
- Clinically significant congestive heart failure with New York Heart Association (NYHA) Class III/IV symptoms.
- The participant has received an organ transplant, has undergone major lung surgery, or is currently on a transplant list.
Show all 20Show fewer
- Known history of ongoing malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix).
- Smoker or participant that has ceased smoking for less than one year prior to screening whose levels of cotinine are outside of the normal range of a nonsmoker.
- All participants must agree to refrain from smoking throughout the course of the study.
- The participant is receiving long-term therapy (> 28 days) of parenteral corticosteroids or oral corticosteroids at doses greater than 10 mg/day of prednisone or its equivalent).
- The participant is receiving long-term round-the-clock oxygen supplementation (other than temporary for acute COPD exacerbation, or supplemental oxygen (O2) with continuous positive airway pressure [CPAP], or bi-level positive airway pressure [BiPAP] during the day).
- Participant has contraindications for CT (e.g. body weight and/or body size exceeding the weight and gantry size limits specified by the manufacturer of the CT scanner, inability to lie flat in the CT scanner, claustrophobia, metal prosthesis or pacemaker in the chest wall or upper extremity that would impact lung density assessment).
- Participant is unwilling or unable to modify bronchodilator medications for 6 hours for short acting β2 agonists, 24 hours for long-acting β2 agonists, and 48 hours for long acting anticholinergics prior to the scheduled quantitative CT scan.
- Known severe immunoglobulin A (IgA) deficiency (ie, IgA level < 8 mg/dL at screening).
- Known history of hypersensitivity following infusions of human blood or blood components (eg, human immunoglobulins or human albumin).
- Presence of clinically significant laboratory abnormalities at the screening
- The participant has a clinically significant medical, psychiatric, or cognitive illness, is a recreational drug/alcohol user, or has any other uncontrolled medical condition (eg, unstable angina, transient ischemic attack, uncontrolled hypertension) that, in the opinion of the investigator, would affect participant's safety or compliance or confound the results of the study.
- Participant has been exposed to another IP within 28 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
- Participant is a family member or employee of the investigator.
- If female, participant is pregnant or nursing at the time of enrollment.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States14 sites
Metroplex Pulmonary and Sleep Center
Allen, Texas, 75013
Pulmonary Health Physicians
Fayetteville, New York, 13066
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Houston Pulmonary and Sleep Associates
Houston, Texas, 77065
Indiana University Health
Indianapolis, Indiana, 46202
Pulmonary Disease Specialists, P.A., / PDS Research
Kissimmee, Florida, 34741
Loyola University Health System
Maywood, Illinois, 60153
L&C Professional Medical Research Institute
Miami, Florida, 33144
La Porte County Institute for Clinical Research, Inc.
Michigan City, Indiana, 46360
Newport Native MD, Inc
Newport Beach, California, 92663
Phoenix Medical Research Institute, LLC
Peoria, Arizona, 85381
Element Research Group
San Antonio, Texas, 78258
Renovatio Clinical-Respiratory & Sleep Disorders Specialists
The Woodlands, Texas, 77005
Southeastern Research Center LLC
Winston-Salem, North Carolina, 27103
Canada2 sites
LHSC - Victoria Hospital
London, Ontario, N6A 5W9
Inspiration Research Limited
Toronto, Ontario, M5T 3A9
About this study
Official title: A Stage 1, Prospective, Randomized, Placebo-Controlled, Double- Blind Study to Evaluate the Safety and Efficacy of Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).
- Being tested
- ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg, GLASSIA 60 mg/kg, GLASSIA 120 mg/kg, Human Albumin 2%
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARALAST NP 60 mg/kgBiological
Also called Alpha1-Proteinase Inhibitor (Human), A1PI, Alpha1-Proteinase Inhibitor
ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
ARALAST NP 120 mg/kgBiological
Also called Alpha1-Proteinase Inhibitor, Alpha1-Proteinase Inhibitor (Human), A1PI
ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
GLASSIA 60 mg/kgBiological
Also called Alpha1-Proteinase Inhibitor (Human), A1PI, Alpha1-Proteinase Inhibitor
GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
GLASSIA 120 mg/kgBiological
Also called Alpha1-Proteinase Inhibitor, Alpha1-Proteinase Inhibitor (Human), A1PI
GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
Human Albumin 2%Biological
Human albumin 2% (by appropriate dilution with normal saline solution)
| Study group | Role | What they receive |
|---|---|---|
| ARALAST NP 60 mg/kg | Experimental | 60 mg/kg body weight/week Receives: Biological: ARALAST NP 60 mg/kg |
| ARALAST NP 120 mg/kg | Experimental | 120 mg/kg body weight/week Receives: Biological: ARALAST NP 120 mg/kg |
| GLASSIA 60 mg/kg | Experimental | 60 mg/kg body weight/week Receives: Biological: GLASSIA 60 mg/kg |
| GLASSIA 120 mg/kg | Experimental | 120 mg/kg body weight/week Receives: Biological: GLASSIA 120 mg/kg |
| Placebo | Placebo comparator | Human Albumin 2% Receives: Biological: Human Albumin 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Change in Lung Density Based on Group 1 (ARALAST NP) Versus Placebo, Group 3 and Group 4 (GLASSIA) Versus Placebo
Rate of change in lung density was assessed by computed tomography (CT) densitometry. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. CT lung density at the 15th percentile (PD15) is the threshold below which 15% of the voxels have lower densities, and was used as the parameter for estimating the rate of lung density decline. Rate of change in lung density based on Group 1 (ARALAST NP) versus Placebo, Group 3 and Group 4 (GLASSIA) versus Placebo were reported. The safety analysis set used for all the efficacy parameter assessment.
Measured: Baseline, Early termination of the study (approximately 22 months)
Secondary outcomes (10)
Rate of Change in Lung Density for Each Treatment Group
Rate of change in lung density was assessed by computed tomography (CT) densitometry for each treatment group. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. The safety analysis set used for all the efficacy parameter assessment.
Measured: Baseline, Early termination of the study (approximately 22 months)
Mean Steady State Trough Concentration of Antigenic and Functional Alpha1-Proteinase Inhibitor (A1PI) for ARALAST NP and GLASSIA at Each Dose Level
Mean steady state trough concentration of antigenic and functional alpha1-proteinase inhibitor (a1pi) for ARALAST NP and GLASSIA at each dose level was reported.
Measured: Baseline, Early termination of the study (approximately 22 months)
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. TEAE related to Investigational Product (IP) and Study Procedures (SP) were considered. A non-serious AE is an AE that does not meet the criteria of an SAE. Number of events with related and unrelated serious and non-serious TEAE were reported.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAE related to IP and Study Procedures were considered. Percentage of participants with related and unrelated serious and non-serious TEAE were reported.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Number of Events With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAEs were temporally related to treatment administration (ie, occurred within 72 hours following the end of the infusion). TEAE Related to IP were considered.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAEs were temporally related to treatment administration (ie, occurred within 72 hours following the end of the infusion). TEAE Related to IP were considered.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Number of Events With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
An Adverse Reactions (ARs) plus suspected adverse reaction is any adverse event which met any of the following criteria: an adverse event that began during infusion or within 72 hours following the end of IP infusion; an adverse event considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration; an adverse event for which causality assessment was missing or indeterminate. Adverse reaction included both serious and non-serious ARs.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
An Adverse Reactions (AR) plus suspected adverse reaction is any adverse event which met any of the following criteria: an adverse event that began during infusion or within 72 hours following the end of IP infusion; an adverse event considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration; an adverse event for which causality assessment was missing or indeterminate. Adverse reaction included both serious and non-serious ARs.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With at Least One Infusion Rate Change or Infusion Interruption or Stopped Due to AEs
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Number of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped due to adverse events (AEs) were reported.
Measured: From start of study treatment up to early termination of the study (approximately 22 months)
Number of Participants Who Developed Anti-A1PI Antibodies Following Treatment With ARALAST NP or GLASSIA
Number of participants who developed anti- A1PI antibodies following treatment with ARALAST NP or GLASSIA were reported. Anti-A1PI binding antibody were determined for the samples that tested positive or negative at each assessment time point.
Measured: Baseline, Early termination of the study (approximately 22 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start2 Nov 2016
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
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 Chronic Obstructive Pulmonary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722304
- Sponsor's protocol ID
- 460503
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2016
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stage 1, Prospective, Randomized, Placebo-Controlled, Double- Blind Study to Evaluate the Safety and Efficacy of Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02722304
- Acronym / sponsor ID
- 460503
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 8 Oct 2019
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 is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ARALAST NP 60 mg/kg | Experimental | Biological: ARALAST NP 60 mg/kg60 mg/kg body weight/week |
| ARALAST NP 120 mg/kg | Experimental | Biological: ARALAST NP 120 mg/kg120 mg/kg body weight/week |
| GLASSIA 60 mg/kg | Experimental | Biological: GLASSIA 60 mg/kg60 mg/kg body weight/week |
| GLASSIA 120 mg/kg | Experimental | Biological: GLASSIA 120 mg/kg120 mg/kg body weight/week |
| Placebo | Placebo comparator | Biological: Human Albumin 2%Human Albumin 2% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age at the time of screening
- Endogenous plasma Alpha1-Proteinase Inhibitor (A1PI) level <8 μM at any time during the Screening period for treatment-naïve participants, or following 4-weeks minimum wash-out from previous augmentation therapy in treatment-experienced participants. The screening plasma A1PI level may be repeated if a participant obtains an exclusionary value that is suspected to be due to inadequate washout of A1PI).
- Participant has documented A1PI genotype of Pi*Z/Z, Pi*Z/Null, Pi*Malton/Z, Pi*Null/Null, or other rare genotypes (except PI*MS, PI*MZ, or PI*SZ).
- Clinically evident mild-moderate chronic obstructive pulmonary disease (COPD) (according to GOLD criteria for diagnosis) at the time of screening.
- If the participant is treated with any respiratory medications including inhaled bronchodilators, inhaled corticosteroids, or systemic corticosteroids (e.g. prednisone ≤ 10 mg/day or its equivalent), the doses of the participant's medications have remained stable for at least 28 days prior to screening.
Key exclusion criteria (20 listed)
- Known ongoing or history of clinically significant pulmonary impairment other than emphysema/ COPD.
- The participant is experiencing lower respiratory infection (LRTI)/acute pulmonary exacerbation (APE) at the time of enrollment (signing Informed consent form (ICF)). Participant may be rescreened after both clinical resolution of LRTI/APE and having also remained stable for at least 4 weeks after the end of LRTI/APE).
- Known ongoing or history of cor pulmonale.
- Known resting partial pressure of carbon dioxide (PaCO2) levels of > 45 mmHg.
- Clinically significant congestive heart failure with New York Heart Association (NYHA) Class III/IV symptoms.
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 |
|---|---|---|
| ARALAST NP 60 mg/kgAlso: Alpha1-Proteinase Inhibitor (Human), A1PI, Alpha1-Proteinase InhibitorARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy | Biological | ARALAST NP 60 mg/kg |
| ARALAST NP 120 mg/kgAlso: Alpha1-Proteinase Inhibitor, Alpha1-Proteinase Inhibitor (Human), A1PIARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy | Biological | ARALAST NP 120 mg/kg |
| GLASSIA 60 mg/kgAlso: Alpha1-Proteinase Inhibitor (Human), A1PI, Alpha1-Proteinase InhibitorGLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy | Biological | GLASSIA 60 mg/kg |
| GLASSIA 120 mg/kgAlso: Alpha1-Proteinase Inhibitor, Alpha1-Proteinase Inhibitor (Human), A1PIGLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy | Biological | GLASSIA 120 mg/kg |
| Human Albumin 2%Human albumin 2% (by appropriate dilution with normal saline solution) | Biological | Placebo |
Primary outcome
Rate of Change in Lung Density Based on Group 1 (ARALAST NP) Versus Placebo, Group 3 and Group 4 (GLASSIA) Versus Placebo
Time frame: Baseline, Early termination of the study (approximately 22 months)
Rate of change in lung density was assessed by computed tomography (CT) densitometry. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. CT lung density at the 15th percentile (PD15) is the threshold below which 15% of the voxels have lower densities, and was used as the parameter for estimating the rate of lung density decline. Rate of change in lung density based on Group 1 (ARALAST NP) versus Placebo, Group 3 and Group 4 (GLASSIA) versus Placebo were reported. The safety analysis set used for all the efficacy parameter assessment.
10 secondary outcomes
Rate of Change in Lung Density for Each Treatment Group
Time frame: Baseline, Early termination of the study (approximately 22 months)
Mean Steady State Trough Concentration of Antigenic and Functional Alpha1-Proteinase Inhibitor (A1PI) for ARALAST NP and GLASSIA at Each Dose Level
Time frame: Baseline, Early termination of the study (approximately 22 months)
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Number of Events With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Number of Events With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Percentage of Participants With at Least One Infusion Rate Change or Infusion Interruption or Stopped Due to AEs
Time frame: From start of study treatment up to early termination of the study (approximately 22 months)
Number of Participants Who Developed Anti-A1PI Antibodies Following Treatment With ARALAST NP or GLASSIA
Time frame: Baseline, Early termination of the study (approximately 22 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).
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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
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg and GLASSIA 60 mg/kg in people with Chronic Obstructive Pulmonary Disease and Alpha1-antitrypsin Deficiency, run by Baxalta now part of Shire at 17 sites in 3 countries.
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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 13 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 17 sites in United States, Canada, Australia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Oct 2019). 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?
Rate of Change in Lung Density Based on Group 1 (ARALAST NP) Versus Placebo, Group 3 and Group 4 (GLASSIA) Versus Placebo (time frame: Baseline, Early termination of the study (approximately 22 months)). 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 13 May 2021.