ABOUT THIS STUDY
- Subject had successfully completed either Protocol Fx-006 or Fx-1A-201.
- Male or female subjects with ATTR-PN who had not undergone liver or heart transplantation at time of enrollment.
- If female, subject was post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control
- Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs)
- Pregnant or breast feeding female subjects.
- Clinically significant medical condition that, in the opinion of the investigator,
would place the subject at an increased risk to participate in the study.
- An alanine aminotransferase (ALT) and aspartate aminotransferase (AST) value >3 ×
upper limit of normal (ULN) that, in the medical judgment of the investigator, was due
to reduced liver function or active liver disease.
- Sexually active males with partners of childbearing potential not using highly
effective contraception or not agreeing to continue highly effective contraception for
at least 3 months after last dose of study drug.
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