Patients with Alpha-1 Antitrypsin Deficiency (AATD) will be enrolled to receive multiple
doses of ARC-AAT Injection. All subjects will require a pre-dose biopsy and a biopsy post
Drug: ARC-AAT Injection
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02900183
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or non-nursing female patients 18-75 years of age, inclusive, at the time of Screening
Previous diagnosis of PiZZ genotype Alpha-1 Antitrypsin Deficiency (AATD)
Non-smoker (not a daily cigarette smoker) for at least three years with current non-smoking status confirmed by urine cotinine at screening.
Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the last dose of ARC-AAT Injection
Suitable venous access for blood sampling
Known diagnosis of hepatic fibrosis from a cause other than AATD
History of poorly controlled autoimmune disease, or any history of autoimmune hepatitis
Human immunodeficiency virus (HIV) infection
Seropositive for Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
History of cardiac rhythm disturbances
Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease, transient ischemic attack (TIA) or cerebrovascular accident
(CVA) within 6 months prior to study entry
History of malignancy within the last 2 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
History of major surgery within 1 month of Screening
Regular use of alcohol within one month prior to the Screening visit
Use of illicit drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to Screening or positive urine drug screen at Screening
Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving a therapeutic intervention
Any clinically significant history/presence of an uncontrolled systemic disease
Blood donation (≥500 mL) within 7 days prior to study treatment administration
All locations for NCT02900183
Inspiration Research Limited
Toronto, Ontario, Canada, M5T3A9
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Skane University Hospital, Department of Gastroenterology
Malmo, Sweden, SE-205 02
View full eligibility
Tris trial is registered with FDA with number: NCT02900183. The sponsor of the trial is Arrowhead Pharmaceuticals and it is looking for 0 volunteers for the current phase.
Official trial title: An Open-Label, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Effect on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels of ARC-AAT as Evidenced by Changes in Liver Biopsy in Patients With Alpha-1 Antitrypsin Deficiency (AATD)
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