Long-term safety of weekly alpha1-proteinase inhibitor in alpha1 antitrypsin deficiency
Tests weekly intravenous alpha1-proteinase inhibitor in adults with emphysema from alpha1 antitrypsin deficiency.
Plain-language title generated from the registry record
Registry title: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
Key facts
- Where
- Adelaide, Chermside, Darlinghurst, Fitzroy, and Nedlands, AustraliaSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with emphysema from alpha1-antitrypsin deficiency who took part in the earlier GTi1201 study. It gives weekly Alpha1-MP 60 mg/kg for 2 more years to check safety.
- Age
- 20 Years to 72 Years
- Sex
- All sexes can join.
- Disease stage
- Pulmonary emphysema due to alpha1-antitrypsin deficiency. People must have finished study GTi1201 (Week 156 and Week 160/End-of-Study Visit), or had a lung function (FEV1) decline of ≥134.4 mL/year at or after the Week 104 Visit.
- Earlier treatment
- Must have taken part in the earlier study GTi1201. Cannot be in another investigational product study now.
Main reasons for not taking part
- Cannot have a CT scan, for example cannot fit in the scanner or is claustrophobic
- Severe other disease, such as congestive heart failure or liver cirrhosis
- Current smoking, including e-cigarettes, or a positive urine cotinine test due to smoking
- Pregnant or breastfeeding, or unwilling to use highly effective contraception if able to have children
- Past anaphylaxis or severe reaction to plasma-derived alpha1-PI or other blood products
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 72 years old?
Source: NCT02796937, who can take part
Where in Australia
- AdelaideHospital not named in the registryNo longer taking part
- ChermsideHospital not named in the registryNo longer taking part
- Darlinghurst, New South WalesHospital not named in the registryNo longer taking part
- FitzroyHospital not named in the registryNo longer taking part
- NedlandsHospital not named in the registryNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Grifols Therapeutics LLC
- Trial code
- NCT02796937
- Record updated
- 23 June 2026
- Original description
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).Read full original descriptionShow less
An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).
Inclusion: Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160/End-of-Study Visit) OR has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL/year at or after the Week 104 Visit in GTi1201; Is willing and able to provide informed consent.
Exclusion: Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis; Has a metal object (newly received since starting GTi1201) that might interfere with chest CT quality and quantification. Metal objects include, but are not limited to, cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile, metal weapon fragments, or metal shoulder prosthesis; Has current evidence of chronic alcoholism or illicit drug abuse (addiction); Is currently participating in another investigational product (IP) study; Has primary and/or secondary (metastatic disease) pulmonary malignancy or other current malignancy with <1 year predicted overall survival; Has clinical signs and symptoms of viral infection requiring virus safety testing at the Week 160/End-of-Study Visit or Early Discontinuation Visit in Study GTi1201, and the virus safety test results are indicative of acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V). Note: If the virus safety test results are indicative of acute or chronic infection with HAV, HBV, HCV, HIV, or B19V, the subject will be considered a screen failure and must be withdrawn from the study; Has a history of anaphylaxis or severe systemic response to any plasma- derived alpha1-PI preparation or other blood product(s); Has any medical condition that the investigator feels might confound the results of the study or pose an additional risk to the subject during study participation; Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic); Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom or occlusive cap with spermicidal foam/gel/film/cream/suppository; male sterilization; or abstinence) throughout the study; Has current evidence of smoking, which includes electronic/vapor cigarettes, or has a positive urine cotinine test at the Week 160/End-of- Study Visit in Study GTi1201 that is due to smoking; In the opinion of the investigator, is likely to have compliance problems with the protocol and the procedures of the protocol.