NL-OMON53804尚未招募3 期
An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301) - Extension study and safety monitoring of AG10 in ATTR-CM
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible to participate in this OLE study, participants must meet all the
- •following criteria:
- •1. Completed 30 months of the blinded study treatment in Study AG10-301 and the
- •Study AG10-301 Month 30 visit including assessments and procedures.
- •2. Have the ability to understand and sign a written informed consent form,
- •which must be obtained prior to initiation of study procedures.
- •3. 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.
排除标准
- •Participants who meet any of the following criteria at the Day 1 visit will not
- •be eligible to participate in the study:
- •1. Has hemodynamic instability, that in the judgment of the Investigator, would
- •pose too great a risk for participation in the study.
- •2. Has had a heart and/or liver transplant within the year prior to Day 1.
- •3. Has had implantation of a cardiac mechanical assist device (CMAD).
- •4. Has confirmed diagnosis of light-chain (AL) amyloidosis at any time during
- •Study AG10-301.
- •5. Is on dialysis or has a degree of renal impairment that in the opinion of
- •the Investigator might jeopardize the participant*s safety, increase their risk
- •from participation, or interfere with the study.
- •6. Known hypersensitivity to acoramidis, its metabolites, or formulation
- •excipients.
- •7. At the end of Study AG10-301 or at Day 1 of Study AG10-304 (or any time
- •during the study), participant is on prohibited medication.
- •8. Females who are pregnant or breastfeeding. A negative urine pregnancy test
- •at the Day 1 visit and at each study visit are required for female participants
- •of childbearing potential.
- •9. In the judgment of the Investigator or Medical Monitor, has any clinically
- •important ongoing medical condition or laboratory abnormality or condition that
- •might jeopardize the participant*s safety, increase their risk from
- •participation, or interfere with the study.
- •10. Participation in another interventional clinical trial (with the exception
- •of Study AG10-301) within 30 days prior to dosing. Participation in
- •observational and/or registry studies should be discussed with the Medical
- •11. Has any condition that in the opinion of the Investigator or Medical
- •Monitor would preclude compliance with the study protocol such as a history of
- •substance abuse, alcoholism, or a psychiatric condition.
研究者
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