EUCTR2016-004664-18-ES进行中（未招募）1 期
A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
Prothena Therapeutics Limited0 个研究点目标入组 100 人开始时间: 2017年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Inclusion Criteria (subjects must meet all of the following criteria):
- •1. Completed the EOS Visit in Study NEOD001-201
- •2. Adequate bone marrow reserve, hepatic and renal function, as demonstrated by:
- •- Absolute neutrophil count (ANC) =1.0 × 109/L
- •- Platelet count =75 × 109/L
- •- Hemoglobin =9 g/dL
- •- Total bilirubin =2 × upper limit of normal (ULN)
- •- Aspartate aminotransferase (AST) =3 × ULN
- •- Alanine aminotransferase (ALT) =3 × ULN
- •- Alkaline phosphatase (ALP) =5 × ULN (except for subjects with hepatomegaly and isozymes specific to liver, rather than bone)
- •- Estimated glomerular filtration rate (eGFR) =25 mL/min/1.73 m2 as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, or measured GFR =25 mL/min/1.73 m2
- •3. Systolic blood pressure 80-180 mmHg
- •4. Women of childbearing potential (WOCBP) must have a negative pregnancy test during Screening and must agree to use highly effective physician-approved contraception (Appendix 2) from Screening to 90 days following the last study drug administration
- •5. Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception (Appendix 2) from Screening to 90 days following the last study drug administration
- •6. Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of any study procedures
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria (subjects must not meet any of the following criteria):
- •1. Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiographic (ECG) examination (e.g., atrial fibrillation; with the exception of subjects for whom the ventricular rate is controlled) that precludes continuation or initiation of treatment with NEOD001 or participation in the study
- •2. Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject’s ability to safely receive treatment or complete study assessments
- •3. Myocardial infarction, uncontrolled angina, uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit
- •4. Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
- •5. ECG evidence of acute ischemia or active conduction system abnormalities with the exception of any of the following:
- •- First degree atrioventricular (AV) block
- •- Second degree AV block Type 1 (Mobitz Type 1/ Wenckebach type)
- •- Right or left bundle branch block
- •- Atrial fibrillation with a controlled ventricular rate (uncontrolled [i.e., >110 bpm] ventricular rate is not allowed [determined by an average of three beats in Lead II or 3 representative beats if Lead II is not representative of the overall ECG])
- •6. Has not recovered (i.e., equivalent to a Common Terminology Criteria for Adverse Events [CTCAE] =Grade 2) from the clinically significant toxic effects of prior anticancer therapy. Exception: subjects who have received treatment with a proteasome inhibitor such as bortezomib may have CTCAE Grade 2 neuropathy.
- •7. Received any of the following within the specified time frame prior to the Month 1-Day 1 Visit:
- •- Oral or IV antibiotics, antifungals, or antivirals within 1 week, with the exception of prophylactic oral agents. Note: In the event that a subject requires the chronic use of antivirals, Medical Monitor permission is required for entry into the study.
- •- Hematopoietic growth factors, transfusions of blood or blood products within 1 week
- •- Chemotherapy, radiotherapy, HDAC inhibitors, or other plasma cell directed therapy within 2 weeks
- •- ASCT within 4 weeks (i.e., ASCT is allowed if it occurred before enrollment in Study NEOD001-201 or after completion of Study NEOD001-201 if it was at least 4 weeks before Month 1-Day 1 of this study)
- •- Major surgery within 4 weeks (or within 2 weeks following consultation with and approval of Medical Monitor)
- •- Planned organ transplant during the study
- •- Any investigational agent, other than NEOD001, within 4 weeks
- •- Any experimental imaging agent directed at amyloid within 2 weeks
- •8. Active malignancy with the exception of any of the following:
- •- Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer
- •- Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for =2 years
- •- Low-risk prostate cancer with Gleason score <7 and prostate-specific antigen <10 mg/mL
- •- Any other cancer from which the subject has been disease-free for =2 years
- •9. History of Grade =3 infusion-related adverse events (AEs) or hypersensitivity to NEOD001
- •10. History of severe allergy to any of the components of NEOD001 such as histidine/L-Histidine, Trehalose, or Polysorbate 20
- •11. Currently known uncontrolled bacterial, vi
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