EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-… (NCT06194825) | Clinical Trial Compass
Active — Not RecruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
China64 participantsStarted 2023-12-01
Plain-language summary
The purpose of this study is to investigate the effect of eplontersen compared to placebo on the reduction of serum TTR concentration and long-term safety in Chinese participants with hereditary or wild-type transthyretin amyloid cardiomyopathy.
Who can participate
Age range20 Years – 90 Years
SexALL
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Inclusion criteria
✓. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
✓. 20 to 90 years of age (inclusive).
✓. Females: must be non-pregnant and non-lactating and either:
✓. post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the post-menopausal range for the laboratory involved);
✓. abstinent\* or,
✓. if engaged in sexual relations of child-bearing potential, agree to use 1 highly effective contraceptive method from the time of signing the informed consent form until at least 24 weeks after the last dose of study intervention (eplontersen or placebo).
✓. Willing to be genetically tested for mutations in the TTR gene before study intervention administration, if it was not done before.
Exclusion criteria
✕. Acute coronary syndrome, unstable angina, stroke, TIA, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months prior or during screening.
✕. Hospitalization or urgent visit to emergency department/emergency room for worsening of HF with discharge date within 4 weeks prior to or during screening.
What they're measuring
1
Percent change of serum TTR concentration from baseline
✕. Uncontrolled hypertension (systolic BP \> 160 mmHg or diastolic BP \> 100 mmHg).
✕. Uncontrolled clinically significant cardiac arrhythmia, per investigator's assessment (e.g., no pacemaker, although indicated).
✕. Severe uncorrected cardiac valvular disease.
✕. Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
✕. Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion, per investigator's assessment.