Assessment of Changes in a Novel Histological Activity Scale in Response to ARO-AAT
Alpha 1-Antitrypsin Deficiency / Posted 1 year ago
The purpose of this study is to evaluate the effect of ARO-AAT Injection (also referred to as ARO-AAT) on a histological liver disease activity scale in participants with AAT-associated liver disease over time. Participants will receive multiple subcutaneous doses of ARO-AAT.
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Inclusion Criteria :
- Diagnosis of AATD
- Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception
- Willing to provide written informed consent and to comply with study requirements
- Non-smoker for at least 1 year
- No abnormal finding of clinical relevance at screening
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Exclusion Criteria :
- Clinically significant health concerns other than AATD
- Previous diagnosis or diagnosis at Screening of definitive liver cirrhosis
- Regular use of alcohol within one month prior to Screening
- Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving therapeutic intervention
- Use of illicit drugs within 1 year prior to Screening
- Study start date : 15/11/2019
- Study end date : 15/11/2021
- Wales-Based Study Contact : please speak to your clinician
- Principal Investigator : Alice Turner