EUCTR2016-000868-42-DE进行中（未招募）1 期
A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OFTAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 study.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1330
排除标准
- •1. Chronic use of diflunisal, TTR stabilizer, tauroursodeoxycholate, doxycycline, digitalis, calcium channel blockers, investigational drug(s) or other experimental interventions, other than tafamidis, independently or as part of a study within 30 days prior to enrollment.
- •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.
研究者
相似试验
进行中（未招募）
1 期
Phase 3, double-blind randomized, long-term extension safety study designed to obtain additional safety data for 20 mg and 80 mg tafamidis and to continue to provide subjects who have completed 30 months of blinded treatment on Protocol B3461028 with tafamidis for up to 60 additional months, or until subject has access to tafamidis for ATTR-CM via prescription, whichever occurs first.EUCTR2016-000868-42-ITPFIZER INC1,440
进行中（未招募）
1 期
Phase 3, open label study designed to obtain additional safety data for 20mg and 80mg tafamidis or tafamidis 61mg where available, continue providing to subjects who have completed 30 months of blinded treatment on Protocol B3461028 with tafamidis for up to 60 additional months, or until subject has access to tafamidis for ATTR-CM via prescription. Additional group of patients who have not previously participated in B3461028 included to received tafamidis until local availability by precription.EUCTR2016-000868-42-GBPfizer Inc.2,000
进行中（未招募）
1 期
Phase 3, open label study designed to obtain additional safety data for 20mg and 80mg tafamidis or tafamidis 61mg where available, continue providing to subjects who have completed 30 months of blinded treatment on Protocol B3461028 with tafamidis for up to 60 additional months, or until subject has access to tafamidis for ATTR-CM via prescription. Additional group of patients who have not previously participated in B3461028 included to received tafamidis until local availability by precription.Transthyretin amyloid cardiomyopathy (ATTR-CM)MedDRA version: 20.0Level: LLTClassification code 10002020Term: Amyloid cardiomyopathySystem Organ Class: 100000004849EUCTR2016-000868-42-NLPfizer Inc.2,000
招募中
不适用
PHARMACOKINETICS, EFFICACY AND SAFETY OF ABATACEPT ADMINISTERED SUBCUTANEOUSLY (SC) IN CHILDREN AND ADOLESCENTS WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) AND INADEQUATE RESPONSE (IR) TO BIOLOGIC OR NON BIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS)PER-065-13BRISTOL MYERS SQUIBB COMPANY,9
进行中（未招募）
不适用
A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIOMedDRA version: 9.1Level: HLTClassification code 10037401Term: Pulmonary hypertensionsPULMONARY ARTERIAL HYPERTENSIONEUCTR2008-005886-78-BGPfizer Inc., 235 East 42nd Street, New York, NY 10017150