Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Anti… (NCT02900183) | Clinical Trial Compass
WithdrawnPhase 2
Safety, Tolerability and Effect of ARC-AAT Injection on Circulating and Intrahepatic Alpha-1 Antitrypsin Levels
Stopped: Company decision to not initiate trial
Canada, Ireland, Italy0Started 2016-10
Plain-language summary
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 last dose.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* Uncontrolled hypertension
* 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 yea…
What they're measuring
1
Incidence and frequency of adverse events as a measure of safety and tolerability of multiple doses of ARC-AAT Injection
Timeframe: Baseline through Day 287 End-of Study Visit