Clinical Trials

OVERVIEW

The Division of Gastroenterology and Hepatology conducts clinical trials on novel therapeutics for various liver diseases, bringing promising and innovative therapies to our patients.

Our team has extensive experience selecting the right patients for the right trials.

Clinical trials are an important part of the research involved in developing new medical treatments. Enrolling in a clinical trial enables participants to take an active role in their own health care, gain entrance to new research, and contribute to medical science.

Participants must meet specific criteria to be eligible for enrollment in a clinical trial. Some research studies seek participants with illnesses or specific conditions to be studied in the clinicaltrial, while others ask for healthy participants.

CURRENT AND ONGOING TRIALS

Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)

The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: Placebo
  • drug: Fazisiran Injection

Eligibility


Inclusion Criteria:

   - Diagnosis of AATD

   - Liver biopsy at Screening indicating liver fibrosis (score less than F4); a patient
   with no fibrosis may participate based on a previous biopsy conducted within one year

   - Women of childbearing potential must have a negative pregnancy test, cannot be
   breastfeeding, 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

   - Previous lung or liver transplant due to AATD

   - 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

NOTE: additional inclusion/exclusion criteria may apply, per protocol

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Swati Toppo
650-497-4151
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