AG10-304

Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called acoramidis (AG10) for the treatment of a rare disease called symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM occurs when a protein in the blood, called transthyretin, clumps together in the blood and accumulates in the heart. This accumulation in the heart is called amyloidosis. Acoramidis binds to transthyretin and by making transthyretin stable, acoramidis may slow the accumulation in the heart. All participants will receive acoramidis by taking 2 pills twice a day.


Inclusion Criteria

  • Completed 30 months of the blinded study treatment in Study AG10-301 and the Study AG10-301 Month 30 visit including assessments and procedures.
  • Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
  • Female participants of childbearing potential who engage in heterosexual intercourse must agree to use a highly effective method of contraception beginning with enrollment and continuing for 30 days after the last dose of acoramidis. Female participants using oral contraceptives must agree to use an additional birth control method. While not considered highly effective, a double-barrier method is acceptable. A male participant who is sexually active with a female of childbearing potential and has not had a vasectomy must agree to use a double-barrier method of birth control.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

An Open-Label Extension and Safety Monitoring Study of Acoramidis in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial

Details
Disease Type/Condition

ATTR-CM

Principal Investigator

Patel, Jignesh

Age Group

Adult

Phase

III

IRB Number

STUDY00001728

ClinicalTrials.gov ID

NCT04988386

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

ATTR-CM

Principal Investigator

Patel, Jignesh

Age Group

Adult

Phase

III

IRB Number

AG10-304

ClinicalTrials.gov ID

NCT04988386

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?