Assessment of Changes in a Novel Histological Activity Scale in Response to ARO-AAT

 Alpha 1-Antitrypsin Deficiency / Posted 11 months 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.

  • 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
  • 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
Contact details

England- Birmingham/Cambridge Scotland- EdinburghEngland Anita.Pye@uhb.nhs.uk clinicaltrials.gov

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