Phase 2 study for people with Alpha-1 Antitrypsin Deficiency
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Clinical Study Center | Adelaide | Australia | Recruiting |
| Clinical Study Center | Fitzroy | Australia | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Part A:
Key Inclusion Criteria:
* Age 18-70 years.
* Confirmed PiZZ AATD diagnosis.
* Blood total AAT level \<11 μM.
* Willing to discontinue augmentation therapy as required by protocol.
* A postbronchodilator FEV1 ≥40% (Ph 1) of predicted or ≥35% (Ph 2) and an FEV1/FVC \<70% at screening (Ph 1 only).
* Evidence of emphysema on chest imaging.
Key Exclusion Criteria:
* BMI \>30.
* Lung or liver transplant or on waiting list for lung or liver transplant or status post lung volume reduction.
* Clinical evidence of severe bronchiectasis.
* Significant liver disease as defined in the protocol.
* Active hepatitis A, B or C infection
Part B:
Key Inclusion Criteria:
* Age 18-70 years.
* Confirmed PiZZ AATD diagnosis.
* Clinical diagnosis of AATD-related liver disease along with evidence of METAVIR F1, F2, or F3 liver fibrosis.
* A postbronchodilator FEV1 ≥40% (Phase 1) or ≥35% (Phase 2) of predicted at screening.
* FibroScan ≤12 kPa.
Key Exclusion Criteria:
* Lung or liver transplant or on waiting list for lung or liver transplant or status post lung volume reduction.
* Clinical evidence of severe bronchiectasis.
* Previous diagnosis of liver cirrhosis or complications of cirrhosis.
Part C:
Key Inclusion Criteria:
* Age 18-75 years.
* Confirmed PiZZ AATD diagnosis.
* Willing to discontinue augmentation therapy as required by protocol.
* A postbronchodilator FEV1 ≥30% of predicted.
* Evidence of emphysema chest imaging.
* Liver stiffness \<12 kPa.
Key Exclusion Criteria:
* Lung or liver transplant or on waiting list for lung or liver transplant or status post lung volume reduction.
* Clinical evidence of severe bronchiectasis.
* BMI \>40.
* Known history of liver cirrhosis or complications of cirrhosis.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 5 October 2026.
- This page last checked by Voxsanity: 12 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.