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Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema (ELEVAATE)

Primary Purpose

Alpha 1-Antitrypsin Deficiency, Emphysema

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INBRX-101
Zemaira
Sponsored by
Inhibrx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alpha 1-Antitrypsin Deficiency focused on measuring AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, A1PI, AAT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females 18-80 years of age, inclusive, at the time of screening Diagnosis of AATD Evidence of emphysema secondary to AATD FEV1 of ≥ 30% and ≤ 80% predicted at screening Current non-smoking status. Exclusion Criteria: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug Known or suspected allergy to components of INBRX-101, A1PI or human IgG Known selective or severe Immunoglobulin A (IgA) deficiency Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days On waiting list for lung or liver transplant Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening Evidence of decompensated cirrhosis Active cancers or has a history of malignancy within 5 years prior to screening History of unstable cor pulmonale Clinically significant congestive heart failure

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • St Joseph's Hospital and Medical Center
  • David Geffen School of Medicine at UCLA
  • UC Davis Medical Center
  • National Jewish Medical and Research Center
  • Western Connecticut Medical GroupRecruiting
  • GW Medical Faculty Associates - GW Cancer& Blood Disorders
  • GW Medical Faculty AssociatesRecruiting
  • University of FloridaRecruiting
  • University of Miami
  • Pulmonary and Sleep of Tampa Bay
  • Cleveland Clinic Florida
  • University of Chicago
  • Loyola University Medical Center
  • Indiana University
  • M Health Fairview Clinics and Surgery Center - Minneapolis
  • Hannibal ClinicRecruiting
  • Columbia University
  • Oregon Health and Science UniversityRecruiting
  • Clinical Research Associates Of Central PA , LLC
  • Penn State Health Milton S. Hershey Medical Center
  • Velocity Clinical Research - Spartanburg - PPDSRecruiting
  • Houston Methodist Hospital
  • University of Utah Health
  • Donna McIntyreRecruiting
  • Queensland Centre for Pulmonary TransplantationRecruiting
  • Royal Adelaide Hospital
  • Eastern Health Clinical School
  • St Vincent Hospital MelbourneRecruiting
  • Frankston HospitalRecruiting
  • NZRSIRecruiting
  • Ninewells Hospital - PPDS
  • Medicines Evaluation Unit
  • Royal Devon and Exeter Hospital (Wonford) - Barrack Rd
  • Southampton General Hospital
  • Queen Elizabeth Hospital Birmingham
  • Royal Infirmary of Edinburgh - PPDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

INBRX-101 Q3W

INBRX-101 Q4W

Zemaira (A1PI)

Arm Description

IV every 3-weeks (Q3W) and placebo (normal saline)

IV every 4-weeks (Q4W) and placebo (normal saline)

60 mg/kg IV once weekly (QW) and placebo (normal saline)

Outcomes

Primary Outcome Measures

Serum functional AAT (fAAT) levels at steady-state
To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity [ANEC] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in patients treated with INBRX-101 compared to A1PI

Secondary Outcome Measures

fAAT Concentration changes
Mean change in fAAT concentration from baseline to fAAT average concentration at steady-state (Cavg, ss) in patients treated with INBRX-101 compared to A1PI.
Days with fAAT above the lower limit of the normal range
Percentage of days with fAAT above the lower limit of the normal range during steady-state dosing in patients treated with INBRX-101 compared to A1PI.
Incidence of TEAEs
Incidence of all treatment-emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from IP treatment, and infusion reactions will be determined.
Anti-drug antibodies
Frequency of anti-drug antibodies (ADA) against INBRX-101 and endogenous AAT, as well as neutralizing ADA (NAb) against INBRX-101 and endogenous AAT will be determined.
Population Pharmacokinetics: Clearance
Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter clearance
Population Pharmacokinetics: Volume of Distribution
Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter volume of distribution
Covariate Analysis: Biometric Values: Weight
Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101
Covariate Analysis: Biometric Values: Height
Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101
Covariate Analysis: Biometric Values: Age
Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101
Covariate Analysis: Biometric Values: Sex
Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101

Full Information

First Posted
March 28, 2023
Last Updated
October 18, 2023
Sponsor
Inhibrx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05856331
Brief Title
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Acronym
ELEVAATE
Official Title
Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inhibrx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema
Detailed Description
This is a Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of INBRX-101 Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alpha 1-Antitrypsin Deficiency, Emphysema
Keywords
AATD, Alpha 1-Antitrypsin Deficiency, Emphysema, INBRX-101, A1PI, AAT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, active-control, parallel group interventional study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INBRX-101 Q3W
Arm Type
Experimental
Arm Description
IV every 3-weeks (Q3W) and placebo (normal saline)
Arm Title
INBRX-101 Q4W
Arm Type
Experimental
Arm Description
IV every 4-weeks (Q4W) and placebo (normal saline)
Arm Title
Zemaira (A1PI)
Arm Type
Active Comparator
Arm Description
60 mg/kg IV once weekly (QW) and placebo (normal saline)
Intervention Type
Drug
Intervention Name(s)
INBRX-101
Intervention Description
A1PI, Recombinant, Bivalent Fc Fusion Protein
Intervention Type
Drug
Intervention Name(s)
Zemaira
Intervention Description
Alpha1-Proteinase Inhibitor (Human)
Primary Outcome Measure Information:
Title
Serum functional AAT (fAAT) levels at steady-state
Description
To assess the mean change in average fAAT concentration as measured by anti-neutrophil elastase capacity [ANEC] from baseline to average serum trough fAAT concentration at steady-state (Ctrough,ss) in patients treated with INBRX-101 compared to A1PI
Time Frame
32 Weeks
Secondary Outcome Measure Information:
Title
fAAT Concentration changes
Description
Mean change in fAAT concentration from baseline to fAAT average concentration at steady-state (Cavg, ss) in patients treated with INBRX-101 compared to A1PI.
Time Frame
32 Weeks
Title
Days with fAAT above the lower limit of the normal range
Description
Percentage of days with fAAT above the lower limit of the normal range during steady-state dosing in patients treated with INBRX-101 compared to A1PI.
Time Frame
32 weeks
Title
Incidence of TEAEs
Description
Incidence of all treatment-emergent adverse events (TEAEs), TEAEs ≥ Grade 3, serious adverse events (SAEs), TEAEs requiring withdrawal from IP treatment, and infusion reactions will be determined.
Time Frame
32 Weeks
Title
Anti-drug antibodies
Description
Frequency of anti-drug antibodies (ADA) against INBRX-101 and endogenous AAT, as well as neutralizing ADA (NAb) against INBRX-101 and endogenous AAT will be determined.
Time Frame
32 Weeks
Title
Population Pharmacokinetics: Clearance
Description
Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter clearance
Time Frame
32 Weeks
Title
Population Pharmacokinetics: Volume of Distribution
Description
Modeling by means of appropriate software to characterize the pharmacokinetic profile of INBRX-101 via estimation of the parameter volume of distribution
Time Frame
32 Weeks
Title
Covariate Analysis: Biometric Values: Weight
Description
Assessment of the impact of patient's weight [in kg] on the pharmacokinetic profile of INBRX-101
Time Frame
32 Weeks
Title
Covariate Analysis: Biometric Values: Height
Description
Assessment of the impact of patient's height [in cm] on the pharmacokinetic profile of INBRX-101
Time Frame
32 Weeks
Title
Covariate Analysis: Biometric Values: Age
Description
Assessment of the impact of patient's age [in years] on the pharmacokinetic profile of INBRX-101
Time Frame
32 Weeks
Title
Covariate Analysis: Biometric Values: Sex
Description
Assessment of the impact of patient's sex [male or female] on the pharmacokinetic profile of INBRX-101
Time Frame
32 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females 18-80 years of age, inclusive, at the time of screening Diagnosis of AATD Evidence of emphysema secondary to AATD FEV1 of ≥ 30% and ≤ 80% predicted at screening Current non-smoking status. Exclusion Criteria: Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug Known or suspected allergy to components of INBRX-101, A1PI or human IgG Known selective or severe Immunoglobulin A (IgA) deficiency Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days On waiting list for lung or liver transplant Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening Evidence of decompensated cirrhosis Active cancers or has a history of malignancy within 5 years prior to screening History of unstable cor pulmonale Clinically significant congestive heart failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabe Berman
Phone
858-500-7833
Email
clinicaltrials@inhibrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kalabus
Organizational Affiliation
Inhibrx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dianne Freemen
Phone
205-996-2709
Email
dsmurphy@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Cara Porter
Phone
205-975-4440
Email
ceporter@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Michael Wells
Facility Name
St Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4220
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajat Walia, MD
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Semi Yoon
Phone
310-794-2156
Email
Semiyoon0113@g.ucla.edu
First Name & Middle Initial & Last Name & Degree
Roslynn Marzan-McGill
Phone
(310)825-2616
Email
rmcgill@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
John Belperio
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Tompkins
Phone
916-734-3845
Email
dgtompkins@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Tina Tham
Phone
916-734-3351
Email
ttham@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Brooks Kuhn
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Brandorff
Phone
303-398-1811
Email
brandorffj@njhealth.org
First Name & Middle Initial & Last Name & Degree
Robert Sandhaus
Facility Name
Western Connecticut Medical Group
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Najwa Brown
Phone
203-739-6490
Email
Najwa.brown@nuvancehealth.org
First Name & Middle Initial & Last Name & Degree
Margaret Mukwaya
Phone
203-739-5610
Email
margaret.mukwaya@nuvancehealth.org
First Name & Middle Initial & Last Name & Degree
Douglas Kahn
Facility Name
GW Medical Faculty Associates - GW Cancer& Blood Disorders
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haider Nadhem
Phone
202-741-3582
Email
hnadhem@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Daniel Diab
Facility Name
GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haider Nadhem
Phone
202-741-3582
Email
hnadhem@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Khalil Diab
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse West, RN, CCRC
Phone
352-273-8666
Email
jesserwest@ufl.edu
First Name & Middle Initial & Last Name & Degree
(Sandra) Michelle Owens, RN, CRC
Phone
352-273-6339
Email
sowens1@ufl.edu
First Name & Middle Initial & Last Name & Degree
Jorge Lascano
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Biondo
Phone
305-243-2568
Email
jnb184@miami.edu
First Name & Middle Initial & Last Name & Degree
Eliana Mendes
Phone
(305) 243-2568
Email
emendes@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Michael Campos
Facility Name
Pulmonary and Sleep of Tampa Bay
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Thompson
Phone
813-413-7218
Email
athompson@pasotb.com
First Name & Middle Initial & Last Name & Degree
Loraine S Vidal
Phone
8134137218
Email
lsalgado@pasotb.com
First Name & Middle Initial & Last Name & Degree
Rafael Martinez
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3609
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Gurevich
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Spring Maleckar
Phone
773-834-4053
Email
smaleckar@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Michael Allegretti
Phone
773-702-6156
Email
mdallegretti@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Kyle Hogarth
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josie Corral, RN
Phone
708-216-5744
Email
jcorral@luc.edu
First Name & Middle Initial & Last Name & Degree
Adriana Martinez
Phone
708-216-2057
Email
Amartinez59@luc.edu
First Name & Middle Initial & Last Name & Degree
Daniel Dilling
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5128
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Brown, MD
Facility Name
M Health Fairview Clinics and Surgery Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-4800
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Reilkoff, MD
Facility Name
Hannibal Clinic
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Laks
Phone
573-629-3926
Email
Rachel.Laks@hannibalregional.org
First Name & Middle Initial & Last Name & Degree
Humam Farah
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Fisher
Phone
212-305-3745
Email
Acf2163@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Laura D. Fonseca, MS, CCRC
Phone
347-645-347
Email
Lf2560@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Monica Goldklang
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Redmond
Phone
503-494-5531
Email
redmonlo@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Haeun Jung
Phone
503-494-5830
Email
Jungha@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Alan Barker
Facility Name
Clinical Research Associates Of Central PA , LLC
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801-2277
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derica Skarbek
Phone
814-375-3770
Email
derica@clinicalresearchassoc.com
First Name & Middle Initial & Last Name & Degree
Sandeep Bansal
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Grim
Phone
717-531-4513
Email
kgrim@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Kristina Richwine
Phone
717-531-4506
Email
krichwine@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
Timothy Craig
Facility Name
Velocity Clinical Research - Spartanburg - PPDS
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Lanier, RN
Phone
864-515-0092
Email
slanier@velocityclinical.com
First Name & Middle Initial & Last Name & Degree
Janice Morris
Phone
864-515-0092
Email
jmorris@velocityclinical.com
First Name & Middle Initial & Last Name & Degree
Farhan Siddiqui
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manikantha Bolloju
Phone
713-441-3248
Email
mmbolloju@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Valentina Villarroel
Phone
346-238-4365
Email
vvillarroel@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Jihad Youssef
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn Barrus
Phone
801-581-5811
First Name & Middle Initial & Last Name & Degree
Cheryl Pirozzi
Facility Name
Donna McIntyre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
2650
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stevie Anderson
Phone
07 3163 1366
Email
stevie.anderson@mater.org.au
First Name & Middle Initial & Last Name & Degree
Sam Ryan
Phone
07 3163 1366
Email
stevie.anderson@mater.org.au
First Name & Middle Initial & Last Name & Degree
Lucy Burr
Facility Name
Queensland Centre for Pulmonary Transplantation
City
Chermside
State/Province
Queensland
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Bancroft
Phone
61731880211
Email
sandy@lrq.com.au
First Name & Middle Initial & Last Name & Degree
Tracie Corish
Phone
61731880211
Email
tracie@lrq.com.au
First Name & Middle Initial & Last Name & Degree
Daniel Chambers
Facility Name
Royal Adelaide Hospital
City
North Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Holmes
Facility Name
Eastern Health Clinical School
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Menzies
Phone
0390949513
Email
katherine.menzies@monash.edu
First Name & Middle Initial & Last Name & Degree
Emma Jackson
Phone
0390952439
Email
emma.jackson1@monash.edu
First Name & Middle Initial & Last Name & Degree
Francis Thien
Facility Name
St Vincent Hospital Melbourne
City
Fitzroy
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Brenton
Phone
(03) 9231 3135
Email
Sue.brenton@svha.org.au
First Name & Middle Initial & Last Name & Degree
Tamara Matthews
Phone
(03) 9231 3522
Email
Tamara.matthews@svha.org.au
First Name & Middle Initial & Last Name & Degree
Matthew Conron
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Wood
Phone
03 9784 7149
Email
SWood@phcn.vic.gov.au
First Name & Middle Initial & Last Name & Degree
Georgia Noonan
Phone
03 9784 7040
Email
GNoonan@phcn.vic.gov.au
First Name & Middle Initial & Last Name & Degree
David Langton
Facility Name
NZRSI
City
Greenlane
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Gane
Phone
+64 (9) 6385255
Email
mel@nzrsi.health.nz
First Name & Middle Initial & Last Name & Degree
Fay Sommerville
Phone
+64 (9) 6385255
Ext
212
Email
fay@nzrsi.health.nz
First Name & Middle Initial & Last Name & Degree
Michelle Baker
Facility Name
Ninewells Hospital - PPDS
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Spears, MD
Facility Name
Medicines Evaluation Unit
City
Manchester
State/Province
Cheshire
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naimat (Naimatullah) Khan, MD
Facility Name
Royal Devon and Exeter Hospital (Wonford) - Barrack Rd
City
Exeter
State/Province
Devon
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Burden, MD
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aisha Fazleen
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
State/Province
Warwickshire
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Turner
Facility Name
Royal Infirmary of Edinburgh - PPDS
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Rabinovich

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

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