Trial Search Results

Open-Label Study of AG10 in Patients With Cardiomyopathy

This prospective, multicenter open-label study will evaluate the long-term safety, tolerability, PK and PD of AG10 administered on a background of stable heart failure therapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Eidos Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Drug: AG10

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Completed participation in study AG10-201.

   2. Willing and able to comply with the study medication regimen and all study
   requirements.

   3. The ability to understand and provide informed consent, which must be obtained prior
   to initiation of study participation.

   4. Male patients and female patients of childbearing potential who engage in heterosexual
   intercourse must agree to use effective method(s) of contraception.

Exclusion Criteria:

   1. Hemodynamic instability that would pose too great a risk to the subject.

   2. Abnormalities in clinical laboratory tests that would pose too great a risk to the
   subject.

   3. Any clinically significant ongoing medical condition or any laboratory abnormality or
   condition that could adversely affect the safety of the patient.

   4. Known hypersensitivity to study drug (AG10), its metabolites, or formulation
   excipients.

   5. Likely to undergo heart transplantation or placement of a mechanical circulatory
   device within the next year.

   6. Receiving current treatment with diflunisal, tafamidis, green tea, doxycycline,
   TUDCA/Ursodiol, patisiran, inotersen or any other investigational ATTR agent within 14
   days or 5 half-lives of the prior investigational agent (whichever is longer) prior to
   dosing with study drug.

   7. Females who are pregnant or breastfeeding. Lactating females must agree to discontinue
   nursing before the study drug is administered.

Ages Eligible for Study

18 Years - 90 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting