NL-OMON53130已完成3 期
A Phase 3 Multicenter, Open Label Study to Evaluate the Safety of Daily Oral Dosing of Tafamidis Meglumine (PF-06291826-83) 20 mg or 80 mg [or Tafamidis (PF-06291826-00) 61mg] in Subjects Diagnosed with Transthyretin Cardiomyopathy (ATTR-CM)) - Tafamidis - B3461045
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 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
- •1. Male and female subjects with TTR amyloid cardiomyopathy who have completed
- •30 months of study treatment on Protocol B3461028.
- •2. Evidence of a personally signed and dated informed consent document
- •indicating that the subject has been informed of all pertinent aspects of the
- •3. Subjects who are willing and able to comply with scheduled visits, treatment
- •plan, laboratory tests, and other study procedures.
- •4. Male subjects able to father children and female subjects of childbearing
- •potential and at risk for pregnancy must agree to use 2 highly effective
- •methods of contraception hroughout the study and for at least 28 days after the
- •last dose of assigned treatment.
- •Female subjects who are not of childbearing potential (ie, meet at least 1 of
- •the following criteria):
- •* Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •* Have medically confirmed ovarian failure; or
- •* Achieved postmenopausal status, defined as follows: cessation of regular
- •menses for at least 12 consecutive months with no alternative pathological or
- •physiological cause; status may be confirmed by having a serum
- •folliclestimulating hormone (FSH) level confirming the post-menopausal state.
- •All other female subjects (including females with tubal ligations) will be
- •considered o be of childbearing potential.
- •Aanvullend voor cohort B:
- •5. Documentatie van de genetische tests voor transthyretineamyloïdose
- •6. Documentatie van diagnose en gebruikte criteria of congestief hartfalen en
- •de aanwezigheid van
- •amyloïde afzettingen in biopsieweefsel, b.v. vetaspiratie, speekselklier,
- •nervus medianus
- •bindweefselschede of cardiaal
- •7.Documentatie dat primaire (lichte keten) amyloïdose ziekte is geëvalueerd en
- •uitgesloten
- •8. Bewijs van NYHA-classificatie I, II, III of IV
排除标准
- •1. Chronic use of diflunisal, TTR stabilizer, tauroursodeoxycholate,
- •doxycycline, digitalis, patisaran, calcium channel blockers, investigational
- •drug(s) or other experimental interventions, other than tafamidis,
- •independently or as part of a study within 30 months prior to enrollment, or
- •inotersen within 6 months prior to enrolment
- •2. Use of certain non-steroidal anti-inflammatory drugs (NSAIDs)
- •3. Liver and/or heart transplant, or implanted cardiac mechanical assist device.
- •4. Pregnant females (or planning to become pregnant during the study interval);
- •breastfeeding females; male subjects with partners currently pregnant.
- •5. Require initiation of treatment with calcium channel blockers.
- •6. Urinary retention requiring chronic self-catheterization.
- •7. Breach of compliance with treatment/significant protocol violations during
- •conduct of B3461028 for which the subject was accountable.
- •8. Subjects who are investigational site staff members directly involved in the
- •conduct of the study and their family members, site staff members otherwise
- •supervised by the investigator, or subjects who are Pfizer employees directly
- •involved in the conduct of he study.
- •9. Other severe acute or chronic medical or psychiatric condition or laboratory
- •bnormality that may increase the risk associated with study participation or
- •investigational product administration, or that may interfere with the
- •interpretation of study results and, in the judgment of the investigator, would
- •make the subject an appropriate for entry into this study.
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